StemCell Therapy

Jounce Therapeutics (NASDAQ:JNCE) is a biotech that should be on your radar in the coming weeks. That's because it is set to present new data from the ICONIC trial for its vopratelimab drug to treat patients with advanced solid tumors. This presentation will pretty much show why an RNA signature was selected to become a predictive biomarker for the potential of improved clinical outcomes in cancer patients. With such data on hand, there is an ability to initiate the phase 2 SELECT study in 2020 to use vopratelimab in combination with its other PD-1 inhibitor product known as JTX-4014. Besides this mid-stage SELECT study, there is another trial ongoing known as EMERGE. Both of these studies provide shots on goal for the monoclonal antibody of vopratelimab. A few catalysts in 2020 could help boost the value of the stock.

Why I believe that Jounce Therapeutics is a good speculative biotech is because of its approach to using a predictive RNA signature biomarker to potentially help increase clinical response rates in patients with certain types of cancer. I am taking the stance that future immunotherapy products are leaning more towards biomarker targeted drugs. That's why Jounce intends to initiate a phase 2 study with vopratelimab in mid-2020 known as SELECT. The basis of this study is that a predictive RNA signature biomarker will help choose only those patients who are to likely respond to treatment. I'm not bullish on this speculative biotech only because of the predictive biomarker approach being deployed in this study. It is also because along with the use of vopratelimab, Jounce intends to add into the mix its mid-stage ready PD-1 inhibitor asset known as JTX-4014. The data to be presented at the ASCO-SITC 2020 conference, taking place between February 6th through the 8th, will display the biomarker RNA signature of ICOS hi CD4 T-cells to be described below. Specifically, from the ICONIC study. What's the rational reason for deploying such a study? That's because in a prior phase 1 study, known as ICONIC, it was shown that patients were able to show a benefit against multiple measures when using vopratelimab alone or in combination with another PD-1 inhibitor known as Opdivo (nivolumab). Such positive measures observed were:

The main mechanism of action for vopratelimab (monoclonal antibody) is that it binds to T-cells and activates "Inducible T-cell Co-Stimulator", thus the name ICOS. ICOS is a protein that is found on the surface of certain T-cells. What's important to note, which is shown above, is that ICOS only activates what is known as ICOS hi CD4 T-cells. These ICOS hi CD4 T-cells are the predictive biomarker to be deployed for the SELECT study. This brings up another point in that vopratelimab only engages CD4 T-cells and not CD8 T-cells. Why is that important? That's because CD4 T-cells are known to elicit a more robust response, while CD8 T-cells are not as keen. One other fact is that CD4 T-cells are known as helper cells, and they stimulate other immune cells in the body. They offer an adaptive immune response in both helping suppress and/or regulate immune responses. The initiation of the phase 2 SELECT study will be an important milestone for Jounce, which I believe will be a catalyst for the stock. The presentation of biomarker data at the ASCO-SITC 2020 conference will act as another catalyst. The mid-stage SELECT study will be initiated in mid-2020. From there, interim results from this study won't be released until 2021.

There is another shot on goal with the use of vopratelimab. This is a phase 2 study known as EMERGENCE, which had already been initiated in June of 2019. What's different about the EMERGENCE study is that it doesn't include a biomarker like the phase 2 SELECT study noted above. In other words, this is more of a broad approach to treating patients with cancer. Having said that, it doesn't get away from the main mechanism of action of vopratelimab, which is inducing ICOS hi CD4 T-cells to kill cancer cells. This phase 2 EMERGENCE study is going to be using the combination of vopratelimab + Yervoy (ipilimumab). Wait a second, why the need for Yervoy to be incorporated into this study? That's because Yervoy is an anti-CTLA4 inhibitor. It attaches to cancer cells and inhibits the CTLA4 response, which in essence helps boost the immune response against target cancer cells. There is another item that Yervoy does which is crucial and lines up with the mechanism of action of vopratelimab. It also induces ICOS hi T-cells like vopratelimab. Thus, the two products together each have a goal in this study:

So Yervoy acts like the launcher of inducing ICOS hi, and then vopratelimab is responsible for increasing such activity and then letting it sustain for a longer period of time. I believe such a mechanism has the chance to exhibit a more sustained durable response for cancer patients. This phase 2 study is being tested in patients with non-small cell lung cancer (NSCLC) and urothelial cancer. It is expected that efficacy and biomarker data from the EMERGE study will be revealed by the 2nd half of 2020.

According to the 10-Q SEC Filing, Jounce Therapeutics had cash, cash equivalents and investments of $185.1 million as of September 30, 2019. The company believes that it will have a gross cash burn between $80 million and $95 million for 2020. The company believes it has enough cash on hand to fund its operations into the second half of 2021. In my opinion, this is just an estimate. I think that once it initiates the phase 2 SELECT study, along with possibly advancing other early-stage studies, it is possible that the gross cash burn rate could increase. Another possible scenario is that it may choose to raise cash after positive data is released. When a company's stock trades higher on the back of positive clinical data, biotechs tend to take advantage with an immediate cash raise.

While some good preliminary data came from the phase 1 ICONIC study using vopratelimab in solid tumors was achieved, it is important to note that it is still in early-stage studies. There is no guarantee that the biomarker data to be presented at the ASCO-SITC 2020 conference is going to be highly positive. If that's the case, then it could be a non-event type of a catalyst. The other phase 2 studies noted above, EMERGE and SELECT still have a way to go before data is released for either of those. As for the EMERGE study, clinical data is not expected until the second half of 2020. The SELECT study has yet to be initiated and is not expected to begin until mid-2020. This means that in the short-term, it's quite possible that the stock could trade lower until such data is revealed.

Jounce Therapeutics is looking to take a differentiated approach with the use of its monoclonal antibody vopratelimab. As I laid out above, both phase 2 studies shown above will have one thing in common. That is the mechanism of action of vopratelimab in being able to induce ICOS hi T-cell responses to improved multiple measures in patients with cancer. One approach is to use Yervoy in combination with vopratelimab to accomplish this task. The other approach in the SELECT study is the use of a biomarker (ICOS hi T-cell population to benefit from treatment) and the addition of Jounce's very own PD-1 inhibitor JTX-4014. I believe that Jounce Therapeutics has a good shot to increase clinical outcomes for several cancer patient populations. Thus, I view it as a good speculative buy.

This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33.50% discount price of $399 per year.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Jounce Should Be On Your Radar With Differentiated Approach To Activating Immune System - Seeking Alpha

Q: What is immunotherapy, and what kinds of cancer can it treat?

A: Immunotherapy is a cancer treatment that activates a patients immune system to identify and destroy diseases such as cancer.

Immunotherapy is the future of cancer care, said Dr. Theodoros Teknos, president and scientific director of the University Hospitals Seidman Cancer Center and deputy director of the Case Comprehensive Cancer Center.

This type of treatment is being used to fight a number of cancers of the blood and solid organs such as the liver, spleen, kidneys, adrenals, pancreas, ovaries and uterus. It has been shown most effective in lymphomas, leukemias, melanoma and lung cancer, Teknos said.

The Cleveland Clinic annually treats a few dozen patients with immunotherapy vaccines, the health system said.

Some patients who undergo immunotherapy treatments see their cancerous tumors disappear, said Dr. Dale Shepard, medical oncologist at the Cleveland Clinics Taussig Cancer Center.

A 2019 clinical trial suggested that immunotherapy could give some men with advanced prostate cancer who have exhausted all other treatment options two years or more of life.

UH and the Cleveland Clinic are using these therapies to treat cancer and conducting clinical trials of new immunotherapies. MetroHealth System is holding clinical trials of a new form of immunotherapy for women with recurrent cervical cancer.

UH is the only Midwest site taking part in a new clinical trial investigating the use of immunotherapy on glioblastoma, a type of brain cancer. The trial uses a modified polio virus to target tumor cells and kill them directly, and create an anti-tumor immune response to kill additional tumors.

This is the hottest area of research, Teknos said.

A patients age has no bearing on how well immunotherapy will work, Shepard said. He gave the example of former President Jimmy Carter, who at age 95 is being treated with immunotherapy.

Immunotherapy holds great promise, but it has limitations. The treatments can be used for only some types of cancer, and can come with severe side effects. Costs also can spiral north of $100,000.

Here are some often-used types of immunotherapy:

Immune checkpoint inhibitors

Cancer cells secrete a protein that turns off the immune system. Checkpoint drugs allow the bodys immune system to identify cancer cells and fight them, Teknos said.

Checkpoint inhibitors take the tumors Invisibility Cloak off, UHs Teknos said, using a Harry Potter reference.

Checkpoint inhibitors currently on the market include the brands Keytruda (Pembrolizumab) and Opdivo (Nivolumab).

Checkpoint inhibitors hold the potential for very, very good and long-lasting responses, Shepard said. Chemotherapy typically will not do that.

CAR-T cell therapy

Bodies fight infection using a type of immune cell called T cells. CAR-T-cell therapy works by removing T-cells from a patients blood and modifying them in a laboratory to chimeric antigen receptors (CAR). These altered T-cells are returned to the patients body, where they recognize and destroy cancer cells.

They go out and seek tumors, Shepard said.

Cancer vaccines

Some types of anti-cancer vaccines target specific proteins found on cancer tumors. This type of anti-cancer vaccine has to be specially tailored for a specific patient.

FDA-approved vaccines include Provenge (sipuleucel-T), which is infused through an IV, for prostate cancer, the Clinic said. Another anti-cancer vaccine is talimogene laherparepvec (T-VEC) for melanoma; it is injected into the tumor.

Other anti-cancer vaccines utilize viruses that grow inside tumors and cause the cancerous cells to break apart. This allows the bodys immune system to recognize and destroy cancer cells.

There are serious risks

Immunotherapy isnt always successful. Some patients see their tumors shrink, but others see no response, or their tumor increases in size, Shepard said.

We dont know how to tell whos who, Shepard said.

Theres evidence that in some cases, ramped-up immune systems created by these therapies attack healthy organs, according to a 2016 New York Times article.

Studies suggest that severe reactions occur nearly 20% of the time with certain drugs, and in more than half of patients when some drugs are used in combination.

Patient deaths led Seattle-based Juno Theraputics to permanently shut down its clinical trial of an immunotherapy to treat acute lymphoblasic leukemia in adults, according to a 2017 Seattle Times article. Five patients in the trials died, but the fifth death could not be tied to the trial. Juno Theraputics did not respond to requests for comment.

Expensive care

Because immunotherapy treatments are time-consuming to make, and sometimes must be personalized for individual patients, they often cost more than $100,000 per patient.

When the therapies are used in combination, costs can double or triple, according to the online publication Vox. For example, CAR-T is $350,000 to $500,000 per treatment, Teknos said.

Private health insurance companies sometimes wont cover immunotherapy costs, even if a physician recommends the treatment, according to Vox. Copays are so high that they put the treatment out of reach for most people, the article said.

Medicare doesnt cover the costs of Keytruda or Optivo, according to GoodRx.

When immunotherapy is given to a hospital inpatient, it is included under the diagnosis-related group payment system used to determine hospital payments, a Medicare spokesman said. Local Medicare administrators determine Medicare coverage for outpatient immunotherapy treatments.

Further reading

More detail about Medicare coverage of immunotherapy

The Society for Immunotherapy of Cancer (SITC)

This professional society for the advancement of immunotherapy offers a 40-page booklet free to download.

Cancer.Net

Additional information on immunotherapy in each cancer-specific section.

GoodRx lists patient assistance programs for Opdivo.

ResearchMatch

This is an NIH-funded free registry for people trying to find research studies to join.

Recent Health Matters columns by Julie Washington:

Hospitals say leave meds at home; readers say otherwise

Where to get help paying your medical bill

Tips for a smooth transition to a skilled nursing facility

Local celebrities share their healthy 2020 resolutions: Health Matters

Creating healthy habits for 2020: Health Matters

Shingles vaccine and virus: What you need to know: Health Matters

In her column, patient advocacy writer Julie Washington will answer readers questions about navigating health-care systems. (She will not address individual treatments.) Your comments may be published in a future story or column. Send questions and comments for publication including your name, city and daytime phone number to jwashington@plaind.com. You can also find Julie on Twitter @JulieEWash.

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Immunotherapy called the future of cancer care, but not without risks, costs: Health Matters - cleveland.com

Work has begun at multiple organizations, including the National Institutes of Health, to develop a vaccine for this new strain of coronavirus, known among scientists as 2019-nCoV.

Scientists are just getting started working, but their vaccine development strategy will benefit both from work that has been done on closely related viruses, such as SARS and MERS, as well as advances that have been made in vaccine technologies, such as nucleic acid vaccines, which are DNA- and RNA-based vaccines that produce the vaccine antigen in your own body.

No, but work was ongoing for other closely related coronaviruses that have caused severe disease in humans, namely MERS and SARS.

Scientists had not been concerned about this particular strain, as we did not know that it existed and could cause disease in humans until it started causing this outbreak.

Work on vaccines for severe coronaviruses has historically begun once the viruses start infecting humans.

Given that this is the third major outbreak of a new coronavirus that we have had in the past two decades and also given the severity of disease caused by these viruses, we should consider investing in the development of a vaccine that would be broadly protective against these viruses.

This work involves designing the vaccine constructs for example, producing the right target antigens, viral proteins that are targeted by the immune system, followed by testing in animal models to show that they are protective and safe.

Once safety and efficacy are established, vaccines can advance into clinical trials in humans. If the vaccines induce the expected immune response and protection and are found safe, they can be mass produced for vaccination of the population.

Currently, we lack virus isolates or samples of the virus to test the vaccines against. We also lack antibodies to make sure the vaccine is in good shape. We need the virus in order to test if the immune response induced by the vaccine works.

Also, we need to establish what animals to test the vaccine on. That potentially could include mice and nonhuman primates.

Vaccine development will likely take months.

We expect that these types of outbreaks will occur for the foreseeable future in irregular intervals.

To try to prevent large outbreaks and pandemics, we need to improve surveillance in both humans and animals worldwide as well as invest in risk assessment, allowing scientists to evaluate the potential threat to human health from the virus, for detected viruses.

We believe that global action is needed to invest in novel vaccine approaches that can be employed quickly whenever a new virus like the current coronavirus and also viruses similar to Zika, Ebola or influenza emerges.

Currently, responses to emerging pathogens are mostly reactive, meaning they start after the outbreak happens. We need a more proactive approach supported by continuous funding.

Aubree Gordon, Professor of Public Health, University of Michigan and Florian Krammer, Professor of Vaccinology, Icahn School of Medicine at Mount Sinai.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Link:
Will There Be a Vaccine For The New Wuhan Coronavirus? If So, When? - ScienceAlert

Inducing immune bee genes

Honey bees are prone to parasitism by the Varroa mite, which is a vector for several bee pathogens. However, honey bees are also host to the symbiotic gut bacterium Snodgrasella alvi. Leonard et al. engineered S. alvi to produce double-stranded RNA (dsRNA)a stimulus for insect RNA interference defense responsesfrom a plasmid containing two inverted promoters tagged with a fluorescent label (see the Perspective by Paxton). This dsRNA module can be targeted to interfere with specific bee genes as well as crucial viral and mite genes. The authors found that gene expression could be blocked for at least 15 days as the symbionts established in the bees' guts and continuously expressed the dsRNA constructs. S. alvi with specifically targeted plasmids not only suppressed infection with deformed wing virus but also effectively reduced Varroa mite survival.

Science, this issue p. 573; see also p. 504

Honey bees are essential pollinators threatened by colony losses linked to the spread of parasites and pathogens. Here, we report a new approach for manipulating bee gene expression and protecting bee health. We engineered a symbiotic bee gut bacterium, Snodgrassella alvi, to induce eukaryotic RNA interference (RNAi) immune responses. We show that engineered S. alvi can stably recolonize bees and produce double-stranded RNA to activate RNAi and repress host gene expression, thereby altering bee physiology, behavior, and growth. We used this approach to improve bee survival after a viral challenge, and we show that engineered S. alvi can kill parasitic Varroa mites by triggering the mite RNAi response. This symbiont-mediated RNAi approach is a tool for studying bee functional genomics and potentially for safeguarding bee health.

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Engineered symbionts activate honey bee immunity and limit pathogens - Science Magazine

MANILA - A strong immune system and avoiding interaction with those infected with the new coronavirus are the best ways to block the illness, a public health expert said Tuesday.

The mysterious new strain, which can cause a pneumonia-like acute respiratory infection, has so far killed 106 people in China and infected some 4,000 across the world.

"The only thing that will help us fight off the disease is not interact with those who are sick," Dr. Susan Mercado told ANC's Headstart.

"Have a balanced diet, sleep the right number of hours, get good physical exercise. Its about staying healthy, eating fruits and vegetables, drinking a lot of water."

The new virus could be spreading through droplets, for instance when people sneeze or cough, or through direct contact with infected people or with objects they have touched, the World Health Organization said.

It remains unclear if the virus, known as 2019nCoV, is contagious before symptoms of fever or respiratory difficulties appear, it added.

"This virus is in human beings. What we need to do is limit the movement of those who are sick and avoid those who are sick. If they get well and they fight off the virus, the virus dies in them," Mercado said.

The Philippines has yet to confirm a case of the mysterious new strain of virus but it will be able to conduct tests for the virus "within the week," according to Mercado.

Manila earlier sent to Australia the specimen of a child in Cebu who came from Wuhan and tested positive for non-specific coronavirus. The child's specimen later yielded a negative result for the 2019nCoV.

Eleven foreigners in the Philippines are quarantined for possible infection from the Wuhan coronavirus, the health department said Monday.

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Water therapy, adequate sleep: Ways to boost immune system to avoid 2019nCoV - ABS-CBN News

LOS ALAMOS, N.M., Jan. 28, 2020 /PRNewswire/ --Knoze Jr Corp releases the study that led to the development of AllerPops, a prebiotic lollipop that gives people lasting allergy relief. The theory proposed in the article explains not only why we have allergies but also how the immune system starts to fight cancer after an infection, which leads to the rare natural cancer regressions. This understanding makes it possible to develop a novel immune therapy that is inexpensive and without dangerous side effects.

When cancer goes away on its own, it's so rare that people often say it's a miracle.

Peregrine Laziosi (12601345) is the patron saint of cancer patients. When he was in his sixties, he developed bone cancer and his only option was to have his leg amputated. The cancer swelled his bone so much that it broke through the skin and it became infected and gave a stinky smell. Miraculously, by the time of his scheduled operation, the doctor found his cancer completely disappeared. Saint Peregrine lived another 20 years before he died at age of eighty-five years old.1

A more recent miracle was used as evidence for the canonization of St. Elizabeth Ann Seton (1774-1821) in 1975. In 1952, Anne Theresa, who was 4, was dying of leukemia. A relic, a cloth touched to Mother Seton's remains, was pinned to the child's gown. Anne almost immediately recovered, and her leukemia was completely healed. 2

The record also shows that just before her recovery, Anne Theresa had severe chickenpox with high fever and nutritionally, she could only tolerate sips ofCoca-Cola. 2

Is there a medical explanation for these miracles?

Cliff Han is the founder of Knoze Jr Corp, a startup firm located in Los Alamos, NM, and inventor of AllerPops. When he reviewed the cases of these cancer miracles, he wanted to find a medical explanation for these acts of God.

"In the two miracles, the people who experienced a natural cancer regression had a serious infection right before the miracle occurred," said Han. "Other than the fact that their immune systems were stimulated by the infections, we still do not know the mechanism leading to the cancer regression."

His study that led to the development of AllerPops, may shed some light on the matter.

AllerPops are prebiotic lollipops that give people lasting allergy relief by targeting the root cause of allergies, a lack of friendly bacteria in the oral cavity.

But what do allergies have to do with cancer?

Han's Theory of Negative Trigger (TNT), developed to explain why we have allergies, can also elucidate how an infection initiate the immune system to fight for cancer.

"If we know how these cancers went away miraculously, we can lead the way for these types of miracles to happen to more people more often," said Han.

TNT describes the relationship between our microbiota and immune systems. Briefly, our immune system is like a car with an accelerator to speed it up and brakes to slow it down. Pathogens acts as an accelerator, stimulating the immune system so it can protect us from infectious diseases. Probiotics (friendly bacteria) act as brakes, slowing it down when there is no infection. Like the car, our immune system is designed to be parked most of the time by the brakes our probiotics.

Our immune system operates in the gut (70%), airway (25%) and under our skin. Different probiotics live in these biological niches and send signals to pacify our immune system. These interactions are primarily local and limited by space and time. The peace agreement between probiotics and the immune system makes it possible for us to live peacefully in the environment.

Read the article that explains TNT here, https://allerpops.com/oral-probiotic-deficiency-may-cause-common-allergies/

How can you stimulate the immune system so it's ready to fight off cancer?

According to Han, a biologist worked at Los Alamos National Laboratory (LANL) for 22 years, two things must happen so that our immune system can be ready to go into battle with cancer.

Both conditions can be automatically fulfilled when a natural infection takes place. A high fever will remove the probiotics that live in the mouth and airway. Diarrhea will remove probiotics in the gut. Reduced appetites will also starve the probiotics in the gut. Pathogens and the damage they cause stimulate the immune system.

Story continues

For example, in the miracle of Anne Theresa described above, the chickenpox infection stimulated Anne's immune system. She had a high fever which inhibited the growth of probiotics in the airway. Drinking only Coca-Cola provided no fiber (food) to the gut probiotics. Without those probiotics, her immune system mobilized at a high level so it could fight the chickenpox virus and the leukemia cells without reservation.

Cancer miracles may happen more frequently if we do these things intentionally. Stimulating the immune system and removing brakes (the friendly bacteria) are both necessary to kick-start the immune system.

How to remove probiotics from your system

Probiotics need food to survive, and so you can slow down their growth by not giving them food. Han said, "I personally did a liquid-only fast (two cups cranberry juice, about 200 calories each day) for a week together with intensified oral hygiene."

How do you activate the immune system?

Recent studies of germ-free mice tested in a sterilized environment where there are no pathogens or probiotics3 indirectly show that removal of probiotics by itself will not activate the immune system.

Some cancer may stimulate the immune system, while most do not.

Therefore, in most cases, one will need vaccines or pathogens to stimulate the immune system. Currently, it is not known how strong the stimulation should be. Stimulation from common cold virus might be too weak. Can controlled chickenpox infection be applied? Only future study will tell.

A bio-firm is developing cancer treatment with Dengue virus stimulating an immune response.4 It is not certain if they included any procedure to remove the brakes.

Instead of using real pathogens/vaccines, controlled infusion of a proper combination of cytokines may be another way to stimulate the immune system.5

The stimulation of the immune system should be done the same time as removing the probiotics in both the airway and gut. Repetitive stimulation may be needed. This method can work alone or be used to improve the performance of modern immune therapy such as PD-1 blocker.

In addition to the explanation of the cancer miracle, the TNT theory suggests other beneficial health practices as well, such as how to prevent allergies, how to recover from a cold faster and why you should keep a fever.

Please check related blogs at allerpops.com/blogs/.

Contact:Cliff HanFounder of AllerPops and owner of Knoze Jr505-695-4236 233085@email4pr.comhttps://www.allerpops.com

References:

View original content to download multimedia:http://www.prnewswire.com/news-releases/mechanism-of-natural-cancer-regression-revealed-through-theory-behind-allerpops-300994081.html

SOURCE Knoze Jr Corp

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Mechanism of Natural Cancer Regression Revealed Through Theory Behind AllerPops - Yahoo Finance

Cases of the flu spiked statewide in Connecticut, with more than 250 people hospitalized and three more deaths in the past week.

According to the Department of Health, the flu is currently widespread statewide, with a total of 1,036 influenza-related hospitalizations reported since the beginning of the flu season.

As of Saturday, Jan. 25, there has been a total of 23 deaths reported, all from residents over the age of 65. No pediatric deaths have been tied to the flu.

There were 4,684 positive influenza tests reported to the Department of Health, with the percentage of emergency department visits for influenza-like illness up 14.36 percent statewide, higher than at this time last year. Influenza-like illnesses were at 7.39 percent, up from 5.87 percent last week.

Nationally, there have been there has been no less than 9.7 million flu illnesses, 87,000 hospitalizations and 4,800 deaths from flu during the current flu season, and health officials said things are expected to get worse before they get better.

In 2018 and 2019, 3,506 people were hospitalized with influenza-associated illness in Connecticut and 88 people died.

According to health officials, "in Connecticut, the Department of Public Health uses multiple systems to monitor circulating influenza viruses. During the influenza season, weekly flu updates are posted from October of the current year, through May of the following year."

The CDC said that reported cases of the flu tend to increase in November before peaking between December and February. Flu season typically lasts through the middle of the spring.

The organization estimates that flu has resulted in between 9.2 million and 35.6 million illnesses each year in the United States and several deaths. Of those illnesses, an estimated 9 percent were hospitalized.

According to the CDC, the flu infects the respiratory tract. As the infection progresses, the bodys immune system responds to fight the virus.

"This results in inflammation that can trigger respiratory symptoms such as a cough and sore throat. The immune system response can also trigger fever and cause muscle or body aches.

"When infected persons cough, sneeze, or talk, they can spread influenza viruses in respiratory droplets to people who are nearby. People might also get flu by touching a contaminated surface or object that has flu virus on it and then touching their own mouth or nose.

Click here to sign up for Daily Voice's free daily emails and news alerts.

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Connecticut Sees Spike In Number Of Flu Cases - Daily Voice

The epicenter of Chinas coronavirus outbreak is widely thought to be a wet market in Wuhan. At such markets, seafood, chicken, and other conventional foodstuffs are on sale alongside live animals. You can buy more than just dogs and cats there. Local epicures also shop for more exotic fare like foxes, badgers, civets, and snakes.

The coronavirus is a pathogen that jumps from animals to humans. The wet market is the perfect environment for the disease to incubate, mutate, and eventually infect the unwary.

Think of Washington, D.C. as Americas political wet market.

Donald Trump is Patient Zero for Americas "kings disease," which is the metonymic translation of coronavirus.

Washington is a place where ordinary politics takes place. But sometimes exotic species are introduced into the nations capital. And thats when a new disease can incubate and mutate and spread throughout the system.

Donald Trump is Patient Zero for Americas kings disease, which is the metonymic translation of coronavirus. His delusions of grandeur were always dangerously infectious, but they only became lethal when he took up residence in the White House.

As Trump came into contact with the ordinary Republican members of Congress, the disease leaped into the American body politic. Virtually the entire Republican Party began to treat the president not as the head of state or the head of the party but as a kingand thus above politics and not subject to the same congressional constraints as previous presidents.

Political scientists are frankly incapable of explaining the current impeachment saga in Washington. It takes an epidemiologist to figure out how a set of politicians, with a wide range of intellectual capabilities from grandmaster to moron, can all deny over and over again the clear evidence in front of their eyes that the president committed impeachable offenses.

Sure, they are marching in lockstep with the party leadership. But it really seems as if theyre suffering from a more serious infection when so many of them have refused to accept the admission of more evidence even as they insist that the existing evidence is insufficient.

Trumpism is not, of course, restricted to the political wet market of Washington, D.C. Plenty of Americans scattered across the country are willing to kneel down before the putative king.

Its unclear how to address this larger outbreak or even if its possible. After all, despite incontrovertible evidence to the contrary, two-thirds of Trump supporters back in 2016 still believed Obama to be a Muslim. Theyve since added more Trump-inspired conspiracy theories to the list, such as Ukraines supposed involvement in hacking the 2016 presidential election. As with mad cow disease, there simply might not be a cure for this political dementia.

But the continuing outbreak of Trumpism goes beyond the headlines about Republican derangement syndrome in Washington or the fever dreams of the presidents so-called base. An equally concerning problem is how Trumpism has infected the entire American system. This is where the political coronavirus actually threatens lives.

Indeed, this systemic infection has put American democracy on life support.

But This Is Evil

Omar Ameen risked his life to bring his family to America. He didnt have a choice.

Born in Iraq, Ameen worried that he and his whole family would be killed by someone taking revenge for the crimes of his cousin, who belonged to al-Qaeda. He left for Turkey in 2012 and, after an exhaustive set of interviews with U.S. screeners, made it into the United States in 2014.

For four years, as Ben Taub relates in a fascinating story in The New Yorker, Ameen worked hard in America to provide for his family. In July 2018, however, U.S. authorities arrested him on the grounds that he had acted on behalf of the Islamic State by killing a police officer in Iraq. The Trump administration had determined that Ameen was a terrorist, one of those bad skittles that Donald Trump Jr. once tweeted about. A network of federal agencies worked overtime to compile an airtight case against Ameen.

The only problem was: Ameen was not in Iraq when the guard was killed. And he could prove it.

This proof, however, didnt seem to matter. The government pursued its case against Ameen regardless, arguing that any evidence gathered after Ameens arrest was only admissible in an Iraqi court, which meant that Ameen would have to be deported. In Iraq, meanwhile, a fair trial is unlikely. Suspected terrorists are routinely tortured into making confessions and then either executed or detained indefinitely.

Its bad enough when Donald Trump lies about, for instance, the big terrorist threat coming from refugees when, in fact, there are virtually no refugee terrorists (aside from several anti-Castro Cubans who arrived before 1980).

Its even worse when the entire federal government is restructured around this lie, when the federal agencies perpetuate this lie on a daily basis, and when innocent people like Omar Ameen get caught up in the web of these lies.

Ameens lawyer, Ben Galloway has been losing sleep over the case.

Its not the stress of going into the hearingits the trauma of coming out of it, the trauma of realizing what theyre doing. Its unconscionable. Seeing the level of infection, this willingness to go along, it makes me realize that we are not safe I hope we can recover from it. I hope we can regain institutional integrity in some of these agencies. None of them is perfectthey all have problematic historiesbut this is evil.

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Mark those words: level of infection. As I said, it takes an epidemiologist to understand the impact of Trumpism on American institutions.

At the Border

It used to be difficult but not impossible to seek asylum at the border. Now, thanks to the Trump administration, its simply impossible.

If the desperate manage to get an interview, which itself is a major challenge, they meet with asylum officers. The Trump administration, arguing that people from south of the border in particular are lying about their cases, has tightened the eligibility requirements by adopting what it calls the Migration Protection Protocols (MPP).

Tightened the eligibility requirementsthats actually a euphemism. The Trump administration has violated international law by refusing asylum to those who face a risk of harm if theyre sent back to the country they left. Some asylum officers, according to This American Life, protested the new rules. They didnt get anywhere.

As reporter Molly OToole explains:

So the standard today is upside down from what it used to be under credible fear. Instead of, lets err on the side of letting people in because we dont want anyone to be tortured or die, under MPP the standard is almost impossibly high, so almost nobody gets in.

In numerical terms, it works out to about one in a thousand (11 out of 10,000, according to Syracuse University). In human terms, it means that every day, U.S. asylum officers are sending people directly into harms way. The use of the phrase concentration camp to describe detention facilities begins to sound grimly appropriate.

Trumps Willing Executioners

Such is the banality of evil. The problem lies not just in the upper echelons of the Trump administration setting the rules. Its everyone down the chain of command who is executing those policies.

True, some people are quitting. Others are blowing the whistle, as weve seen in the cases of the courageous few who testified in the House impeachment hearings. But they are the exceptions. The system continues to function.

Its not just ICE or Homeland Security. A cadre of federal employees at the Department of the Interior is currently opening up public lands to drilling. The Pentagon is expediting millions of dollars of weapons sales to one of the most despicable regimes on the planet, Saudi Arabia. Officials at USAID are enforcing the global gag rule by cutting off funding to organizations that provide access to reproductive health and family planning.

All across the country, tens of thousands of people are implementing the Trump administrations egregious policies. Of course, not everyone working for the federal government is involved in such crimes. Thousands and thousands of civil servants are maintaining programs that the Trump administration has yet to alter or close down that offer essential services or direct critical resources to individuals and communities in need.

But in a post-Trump future, whenever that day comes, how will we deal with the myriad willing executionersto quote Daniel Goldhagens book on the complicity of ordinary Germans in the Holocaust? The contagion spreads far beyond Trump, his cabinet, the Republicans on the Hill, and a few familiar faces in the media.

Compromised Immune System

Trumpism is an acute outbreak of a chronic disease. Americas body politic has been seriously compromised for years.

In Democracy in Chains, Nancy McLean chronicles the efforts by economist James M. Buchanan, the Koch brothers, and a raft of conservative foundations to systematically reduce the influence of the majority of citizens in politics. They have done so through a variety of mechanisms: privatizing federal programs that hitherto had majority support, challenging the power of unions, empowering states at the expense of the federal center.

She asks:

Is what we are dealing with merely a social movement of the right whose radical ideas must eventually face public scrutiny and rise or fall on their merits? Or is this the story of something quite different, something never before seen in American history? Could it beand I use these words quite hesitantly and carefullya fifth-column assault on American democratic governance?

The forces that have engineered this hostile take-over of Washington, D.C. never imagined that Donald Trump would lead their movement. Neither did conservative evangelicals or the NRA. They all expected someone more sober-minded, more calculating, more consistently ideological. Still, a useful idiot is a useful idiot.

Trumpism is what happens when a compromised immune system meets an unusual pathogen. America might be lucky enough to remove the proximate cause of infection through a victory at the polls. The top tier of Trump appointees can then be removed from office.

Unless we address the underlying susceptibility of the body politic to diseases of this nature, however, such outbreaks will continue flaring up for years to come. America faces a political pandemic unlike any in the last 200-plus years. To eradicate this kings disease the last time around, didnt we have to fight a revolution?

Originally posted here:
Americas Coronavirus: Containing the Outbreak of Trumpism - Common Dreams

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The novel coronavirusthat's sickening thousands globally -- andat least five people in the US-- is inspiring countries to close their borders and Americans tobuy up surgical masksquicker than major retailers can restock them.

There's another virus that has infected 15 million Americans across the country and killed more than 8,200 people this season alone. It's not a new pandemic -- it's influenza.

The 2019-2020 flu season is projected to beone of the worst in a decade, according to the National Institute of Allergy and Infectious Diseases. At least 140,000 people have been hospitalized with complications from the flu, and that number is predicted to climb as flu activity swirls.

The flu is a constant in Americans' lives. It's that familiarity that makes it more dangerous to underestimate, said Dr. Margot Savoy, chair of Family and Community Medicine at Temple University's Lewis Katz School of Medicine.

"Lumping all the viral illness we tend to catch in the winter sometimes makes us too comfortable thinking everything is 'just a bad cold,'" she said. "We underestimate how deadly influenza really is."

Even the low-end estimate of deaths each year is startling, Savoy said: The Centers for Disease Control predictsat least 12,000 people will die from the fluin the US every year. In the 2017-2018 flu season, as many as 61,000 people died, and 45 million were sickened.

In the 2019-2020 season so far, 15 million people in the US have gotten the flu and 8,200 people have died from it, including at least 54 children. Flu activity has been elevated for 11 weeks straight, the CDC reported, and will likely continue for the next several weeks.

Savoy, who also serves on the American Academy of Family Physician's board of directors, said the novelty of emerging infections can overshadow the flu. People are less panicked about the flu because healthcare providers "appear to have control" over the infection.

"We fear the unknown and we crave information about new and emerging infections," she said. "We can't quickly tell what is truly a threat and what isn't, so we begin to panic -- often when we don't need to."

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Dr. Nathan Chomilo, an adjunct assistant professor of pediatrics at University of Minnesota Medical School, said that the commonness of the flu often underplays its severity, but people should take it seriously.

"Severe cases of the flu are not mild illnesses," Chomilo said. "Getting the actual flu, you are miserable."

The flu becomes dangerous when secondary infections emerge, the result of an already weakened immune system. Bacterial and viral infections compound the flu's symptoms. People with chronic illnesses are also at a heightened risk for flu complications.

Those complications include pneumonia, inflammation in the heart and brain and organ failure -- which, in some cases, can be fatal.

Chomilo, an internist and pediatrician for Park Nicollet Health Services, said this flu season has been one of the worst his Minnesota practice has seen since the H1N1 virus outbreak in 2009. Some of his patients, healthy adults in their 30s, have been sent to the Intensive Care Unit, relying on ventilators, due to flu complications.

Influenza is tricky because the virus changes every year. Sometimes, the dominant strain in a flu season will be more virulent than in previous years, which can impact the number of people infected and the severity of their symptoms.

Most of these changes in the virus are small and insignificant, a process called antigenic drift. That year's flu vaccine is mostly effective in protecting patients in spite of these small changes, said Melissa Nolan, an assistant professor at the University of South Carolina's School of Public Health.

Occasionally, the flu undergoes a rare antigenic shift, which results when a completely new strain of virus emerges that human bodies haven't experienced before, she said.

Savoy compares it to a block party: The body thinks it knows who -- or in this case, which virus -- will show up, and therefore, which virus it needs to keep out. But if a virus shows up in a completely new getup, it becomes difficult for the body's "bouncers" -- that's the immune system -- to know who to look for and keep out. The stealthy virus can infiltrate easily when the body doesn't recognize it.

This flu season, there's no sign of antigenic shift, the most extreme change. But it's happened before, most recently in 2009 with the H1N1 virus. It became a pandemic because people had no immunity against it, theCDC reported.

To avoid complications from the flu, Savoy, Chomilo and Nolan have the same recommendation: Get vaccinated.

It's not easy to tell how flu vaccination rates impact the number of people infected, but Savoy said it seems that the years she struggles to get her patients vaccinated are the years when more patients end up hospitalized with the flu, even if the total number of infections doesn't budge.

The CDC reported at least173 million flu vaccine doseshave been administered this flu season so far -- that's about 4 million more doses than the manufacturers who make the vaccines projected to provide this season.

Still, there are some who decide skipping the vaccine is worth the risk. A2017 studyfound that people decline the flu vaccine because they don't think it's effective or they're worried it's unsafe, even though CDCresearch showsthe vaccine effectively reduces the risk of flu in up to 60% of the population.

Chomilo said some of his most frustrating cases of the flu are in patients who can't be vaccinated because of preexisting conditions or their age (children under 6 months old can't be vaccinated).

There are two important reasons to get the flu vaccine, he said -- "Protecting yourself and being a good community member."

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Virus has claimed more than 8,000 lives this season, but its not a new pandemic - CBS 4 Indianapolis

Mikhail V. Pletnikov has been named professor and chair of the Department of Physiology and Biophysics in the Jacobs School of Medicine and Biomedical Sciences at UB.

The appointment was announced by Michael Cain, vice president for health sciences and dean of the Jacobs School.

Dr. Pletnikov rapidly emerged as our top candidate possessing the administrative, scientific, leadership and visionary skills needed to move the department forward and further align the department with the Jacobs Schools strategic plans, Cain said in a statement.

Pletnikov, a native of Moscow, Russia, will relocate to Buffalo and join UB on July 1. He will be accompanied by his wife, Olga Pletnikova.

I feel honored to be appointed to this position, Pletnikov said. I am grateful to the members of the search committee, the faculty of the department and personally to Dr. Cain for placing their trust in me to lead the department. I look forward to working with the faculty, staff and students to support and promote education and biomedical research in the department and the school.

On a personal note, Olga and I are excited to move to Buffalo, he said. As for its weather, I am sure we will appreciate all four seasons there as, after all, we used to live in Moscow.

Pletnikov will succeed Perry Hogan, who has served as department chair since 2015.

Pletnikovs research focuses on understanding how neurons and non-neuronal cells (glial cells) interact with one another to support critical brain functions, including emotion and cognition. He also studies the mechanisms whereby the brain regulates functions of different organs in the body and itself is influenced by peripheral systems, particularly the immune system and the gut.

A growing number of studies suggest that abnormalities in these complex interactions lead to the development of disorders of the brain and peripheral organs, he said. Targeting cells, processes and pathways involved in the brain-periphery interplay is emerging as a new promising direction in treatment of complex brain disorders.

Pletnikovs research has been published in numerous journals. He lectures nationally and internationally, and serves on the editorial boards of leading scientific journals in his field, including Genes, Brains and Behavior; Biobehavioral Review; and Biological Psychiatry.

He received his doctorate in medicine from the I.M. Sechenov Moscow Medical Institute and his PhD in normal physiology from the PK Anokhin Institute of Normal Physiology in Moscow. He completed his postdoctoral training in behavioral neuroscience and neurovirology at Johns Hopkins University .

In 2000, Pletnikov joined the faculty at Johns Hopkins as an assistant professor and is currently a professor of psychiatry and behavioral sciences, neuroscience, and molecular and comparative pathology.

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Jacobs School names chair of Physiology and Biophysics - UB Now: News and views for UB faculty and staff - University at Buffalo Reporter

Ever since the coronavirus was identified by Chinese officials in early January, news reports have alerted us to its escalation on an almost hourly basis. With over 4,000 cases in China, 106 of which have proved fatal, new outbreaks of the virus have since been confirmed in Australia, Canada, France and Germany. A respiratory infection similar to SARS, the nature of the coronavirus means it has the potential to spread far and wide, and quickly.

If the virus is actually as contagious as is being currently asserted, modern air travel and the purported time of incubation and asymptomatic status (about two weeks) really means it can spread anywhere on the planet, says cardiologist and vitamin C expert Dr Thomas E. Levy. As with nearly all other contagious viruses, spread is most commonly due to airborne virus in microdroplets from sneezing, coughing and the exhalation of infected individuals.

A sensible first step? A strong immune system is really the only significant protection for an individual, says Dr Levy. And a great deal of immune system strength comes from the vitamin C content in the immune cells. When the levels of vitamin C in the body are low, the immune system can never function at full capacity, he adds. (To boost your natural defences try a daily dose of oral supplementation, anywhere up to 2000mg.)

Understandably, the possibility of a pandemic is enough to cause serious panic. While avoiding exposure to anyone likely affected is an obvious precaution, there are practical ways you can protect yourself and allay your worries. Here are Vogues tips to help you keep calm and carry on.

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Washing your hands frequently isnt just good daily etiquette, its the first line of defence when it comes to warding off the spread of infection. For the most effective results apply warm water to your hands before lathering up with your chosen soap Floriss Luxury Hand Washes make the job more enjoyable. Scrub vigorously for at least 20 seconds to kill any germs, making sure you reach every part including the backs of your hands and under your fingernails, then rinse well and dry. If the occasion means its impossible to get to running water, then a hand sanitiser will suffice; just ensure it contains at least 60 per cent alcohol, which is enough to get to work eliminating almost all classes of germ immediately. When it comes to mixing form and function, Byredos Rinse-Free Hand Wash, (25) does a sterling job: combining Scandi-chic packaging with breezy florals and soft musks, it makes pulling it out of your handbag every hour a pleasure, rather than a chore.

While you might be more familiar with the power of LED therapy when it comes to treating myriad skin ailments (everything from increasing collagen and bounce in the skin to fading acne scars), its also an effective tool in combatting feelings of stress and anxiety. Near-Infrared has a balancing effect on cortisol, which is commonly referred to as the stress hormone, while happy hormones like serotonin and dopamine are triggered by the lights, explains The Light Salon co-founder Laura Ferguson. Add to that the sensation of warmth that gently spreads over your skin for the duration of the treatment, and chances are youll re-emerge much more zen than you went in. Plus, of course, glowing, healthy skin is always a welcome bonus. For a quick but effective blast of bliss without even having to remove your make-up, book in for The Pick-Me-Up (35 for 15mins) at The Light Salon.

Read more: How To Survive A Hormone Crisis In Your Twenties

Meditation can play a key role in providing a sense of clarity and perspective during times of intense worry, something youll already know if youre one of the 40 million global users of the Headspace app. On a physical level, things like meditation, sound healing, reiki healing and breathwork kick in your parasympathetic nervous system, which is responsible for rest and relaxation, and tone down your fight or flight response, explains Yulia Kovaleva, Founder of Re:Mind Studio. To engage with this ancient relaxation technique, regardless of your experience or skill, Yulia suggests the simple step of connecting with your breath. Breathe in, collecting all the tension and tight feelings around your chest, and then exhale. Imagine it moving down through your body, down to your belly, into your pelvis and all the way down into your feet and leaving your body, releasing it into the ground. Best of all, the practice can be done anywhere and anytime, even (and perhaps aptly) on the Central line at 8am.

Not just a way to perk up your evening bath, aromatherapy has a proven impact on issues including depression and insomnia. As we breathe the essential oil, some constituents are absorbed through the nose via the olfactory bulb which communicates with the limbic system, says Annee de Mamiel, aromatherapist and skin practitioner. The limbic system is directly connected to those parts of the brain that control heart rate, blood pressure, breathing, memory, stress levels and hormone balance. Harness the potency by sprinkling a few drops of an inhalation blend inside a tissue; de Mamiels Altitude Oil (30) was created to help protect the immune system and contains linalool-rich lavender to relax the mind, and antiviral eucalyptus, pine and lemon myrtle to fight bacteria and viral pathogens.

Even if not directly affected by trauma, often the thought of perceived risk is enough to make us feel anxious. To set your mind at ease, enlist the help of an herbal tincture to soothe frayed nerves, re-establish a sense of equilibrium and sharpen brain function. Lauded in Ayurvedic medicine, studies have shown that ashwagandha, also known as Indian ginseng, is an adaptogenic herb (meaning it can help your body handle stress better) that can have a significant effect on fighting symptoms of anxiety by modulating cortisol. Try adding a teaspoon to your morning smoothie, or mixing with warm milk and honey before bed.

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5 Ways To Avoid Freaking Out About The Coronavirus - British Vogue

As the emerging Wuhan coronavirus outbreak dominates the daily news, you might be wondering just how the pathogen is working its way around the world. This virus travels from place to place by infecting one person at a time. Some sick people might not spread the virus much further, but it looks like some people infected with the novel coronavirus are what epidemiologists call super spreaders.

Elizabeth McGraw, the director of the Center for Infectious Disease Dynamics at Pennsylvania State University, explains just what that means and why super spreaders can be crucial to a diseases transmission.

Researchers currently estimate that a person carrying the Wuhan coronaviruswill, on average, infect approximately 2.6 people.

Recent reports out of Wuhan also cite a case of a single patient who infected 14 health care workers. That qualifies him as a super spreader: someone who is responsible for infecting an especially large number of other people.

During an emerging outbreak, epidemiologists want to determine whether super spreaders are part of the picture. Their existence can accelerate the rate of new infections or substantially expand the geographic distribution of the disease.

In response to super spreaders, officials can recommend various ways to limit their impact and slow the spread of disease, depending on how the pathogen is transmitted. Pathogens transmitted via air droplets, contaminated surfaces, sexual contact, needles, food or drinking water will require different interventions. For example, the recommendation for face masks would be specific to airborne transmission, while hand-washing and surface sterilization are needed for germs that can live for a while on surfaces.

Whether someone is a super spreader or not will depend on some combination of the pathogen and the patients biology and their environment or behavior at the given time. And in a society with so much global connectivity, the ability to move pathogens rapidly across great distances, often before people are even aware they are sick, helps create environments ripe for super spreading.

Some infected individuals might shed more virus into the environment than others because of how their immune system works. Highly tolerant people do not feel sick and so may continue about their daily routines, inadvertently infecting more people. Alternatively, people with weaker immune systems that allow very high amounts of virus replication may be very good at transmitting even if they reduce their contacts with others. Individuals who have more symptoms for example, coughing or sneezing more can also be better at spreading the virus to new human hosts.

A persons behaviors, travel patterns and degree of contact with others can also contribute to super spreading. An infected shopkeeper might come in contact with a large number of people and goods each day. An international business traveler may crisscross the globe in a short period of time. A sick health care worker might come in contact with large numbers of people who are especially susceptible, given the presence of other underlying illnesses.

There are a number of historical examples of super spreaders. The most famous is Typhoid Mary, who in the early 20th century purportedly infected 51 people with typhoid through the food she prepared as a cook. Since Mary was an asymptomatic carrier of the bacteria, she didnt feel sick, and so was not motivated to use good hand-washing practices.

During the last two decades, super spreaders have started a number of measles outbreaks in the United States. Sick, unvaccinated individuals visited densely crowded places like schools, hospitals, airplanes and theme parks where they infected many others.

Super spreaders have also played a key role in the outbreaks of other coronaviruses, including SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome). A traveler sick with SARS and staying in a Hong Kong hotel infected a number of overseas guests who then returned home and introduced the virus into four other countries.

For both SARS and MERS, super spreading commonly occurred in hospitals, with scores of people being infected at a time. In South Korea in 2015, one MERS patient infected over 80 other patients, medical personnel and visitors in a crowded emergency department over a three-day period. In this case, proximity to the original patient was the biggest risk factor for getting sick.

Yes. Some scientists estimate that in any given outbreak, 20% of the population is usually responsible for causing over 80% of all cases of the disease. Researchers have identified super spreaders in outbreaks of diseases from those caused by bacteria, such as tuberculosis, as well as those caused by viruses, including measles, MERS and Ebola.

The good news is that with the right control practices specific to how pathogens are transmitted hand-washing, masks, quarantine, vaccination and so on the transmission rate can be slowed and epidemics halted.

This article has been updated to correct a typo concerning the disease Typhoid Mary spread.

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What is a super spreader? An infectious disease expert explains - The Conversation US

NIH research is working hard to solve the puzzle of how genes and lifestyle connect to affect our lives and our health. Today, researchers can scan and compare entire genomes very quickly. These studies have already turned up disease signatures for type 2 diabetes, heart disorders, prostate cancer, Crohns disease, Parkinsons disease, and age-related macular degeneration. More disease-related gene variants are identified every few months.

The Human Genome Project and thousands of follow-on studies are helping scientists to develop gene-targeted treatments. A poignant example is the case of a woman with lung cancer that had spread to her brain. Diagnosed in 2002, this 44-year-olda vegetarian who had never smokedunderwent various therapies to stave off what seemed inevitable. Then came a miracle: she learned of a clinical trial testing a new drug, getfitinib, that for some tumors appeared to work as a genetic smart weapon. Her tumor was one of those, and she is alive today because of medical research.

Thanks to NIH-funded basic research that gave us genetic engineering and launched the $40 billion biotech industry, DNA is a household name. Virtually every biomedical research lab and pharmaceutical company throughout the world uses the power of the genomic revolution every day to demystify diseases and find new cures. Within 5 years, the complete DNA instruction bookor whole genomeof an individual will read out for less than $1,000, making genetic analysis a routine part of medical care.

One recent study provides a glimpse of how whole-genome sequencing might eventually be used in the clinic. Scientists evaluated the entire genome of a 40-year-old man to determine his risk for dozens of diseases and his likely response to common drugs. They pinpointed gene variants linked to several diseases in the mans family, including vascular disease and early sudden death. They also found variants linked to conditions not known to be in his family, such as thyroid and parathyroid diseases. Other gene variants predicted the patients likely responses to certain heart medicationsinformation thats especially relevant since hes at risk for cardiovascular disorders.

Remarkable advances in the field of pharmacogenomicshow individuals react differently to medicinesindicate that we are moving away from one-size-fits-all medicine. Scientists can now identify glitches in our DNA scripts that reveal what drugs may be dangerousor completely ineffectivefor certain people. This information will help doctors calculate precise dosages that match a persons DNA.

Collectively, research results in this important area of biomedicine are prompting the U.S. Food and Drug Administration (FDA) to consider changing the labeling requirements for important medicines taken by millions of Americans. Already, pharmacogenomic information is contained in about 10% of labels for drugs approved by the FDA to treat a range of conditions including HIV/AIDS, cancer, seizures, and cardiovascular disorders.

Next: Stem Cells

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Personalized Medicine | National Institutes of Health (NIH)

Say precision medicine and people think of personalized cancer treatment. But this innovation has already begun to revolutionize primary care tooeven though the jury is still out, in many cases, on whether it makes a clear difference in outcomes.

Just what precision (alias personalized) medicine is isnt always spelled out precisely. But usually it is discussed as prevention or treatment that takes into account individual differences among patients, most often genetic differences. Some people expand the concept to consider individual differences in environment and lifestyle.

In adult primary care, two subsets of precision medicine have attracted the most attention recently: predictive genetic testing and pharmacogenomics.

Predictive genetic testing is what it sounds like: A genetic test that forecasts a persons chance of getting a disease. The term is also applied to germline genetic tests that provide some indication of the predisposition being passed down to offspring. Proponents see predictive genetic testing for certain inherited conditions as a way to unearth risks in people who can then get early treatment or take preventive steps to head off serious and possibly costly conditions. Actor Angelina Jolie put BRCA testing as a predictive genetic test into the public consciousness with her announcement in 2013 that she underwent a double mastectomy after testing positive for a BRCA mutation.

Pharmacogenomics studies show how a persons genes can affect his or her response to medications. Ideally, pharmacogenomic (sometimes called pharmacogenetic) results could end some of the trial and error with drugs and help providers and patients choose the most effective drug right off the bat.

Where federal dollars are concerned, precision medicine has already stepped out of the cancer box. In 2015, President Barack Obama committed $215 million to precision medicine research, including a genomic study of more than a million Americans to extend precision medicine from cancer to other diseases. A year later, the 21st Century Cures Act expanded this funding to $1.5 billion over the next 10 years.

Aided by a multibillion-dollar genomic testing industry, some providers have started testing precision medicine beyond oncology. In 2018, Geisinger Health System in central Pennsylvania made a splash by announcing that it would add DNA sequencing to routine primary care. A small number of other hospitals are starting to monetize these tests. In August 2019, STAT reported that a handful of academic medical centers, including Brigham and Womens Hospital and the Mayo Clinic, have started elective genome sequencing clinics for generally healthy patients willing to pay hundreds, sometimes thousands of dollars in cash for a genetic workup.

Skeptics see carts preceding horses; solid evidence that routine genetic testing results in better outcomes is lacking. As one genome-sequencing clinic leader conceded in the STAT article, such testing can lead to expensive follow-up testing. Not surprisingly, payers have been reluctant to cover sequencing tests of various kinds.

Regulators have breathed life into some kinds of testing and poured cold water on others. Last year, 23andMe was the first testing company to get FDA approval to market a direct-to-consumer genetic test for three (of the more than 1,000 known) BRCA gene mutations linked to increased risk of breast, ovarian, and prostate cancer. But in April 2019, the agency issued a warning letter to Inova Health System in Northern Virginia to stop marketing pharmacogenomics tests it claimed could predict patients responses to antidepressants, opioids, and other drugs. The FDA said it was unaware of data to support these claims.

A survey published two years ago in Clinical Pharmacology and Therapeutics found that clopidogrel, a blood thinner, was the medication most commonly tested for a druggene interaction, followed by simvastatin and warfarin. Nearly 40 academic medical centers and community health systems testing ways to implement pharmacogenomics in clinical practice were surveyed.

Some evidence suggests that traditional screening methods may not identify everyone at risk for certain inherited conditions. In a study published in Science three years ago, researchers at Geisinger and Regeneron (which manufactures Praluent, a drug used to treat familial hypercholesterolemia) found that only about one in four people carrying the familial hypercholesterolemia gene variant met the Dutch Lipid Clinic Network criteria (widely used diagnostic criteria) for genetic testing. Still, evidence for the clinical utility of many pharmacogenomic or predictive genetic tests is pretty scanty at this point.

Right now, for the average primary care provider, there are a relatively limited number of situations where pharmacogenomic testing is clearly beneficial to outcomes in a way thats dramatic, says Greg Feero, MD, a faculty member at Maine Dartmouth Family Medicine Residency and a former senior advisor to the director of the NIHs genomics research division.

For predictive genetic testing, there are a few notable exceptionshereditary breast and ovarian cancer, Lynch syndrome, and familial hypercholesterolemiaif certain criteria such as family history of the condition are met. The CDC has designated genomics applications for these conditions as Tier 1, the highest tier on its evidence-based ranking system of genomic applications by their potential for a positive public health impact.

In a 2017 editorial published in American Family Physician, Vinay Prasad, MD, and Adam Obley, MD, of Oregon Health and Science University said that rigorous meta-analyses havent yet shown that genotype-guided dosing for warfarin, clopidogrel, or antidepressant selection is better than usual care. Prasad is a well-known critic of what he sees as the proliferation of medical treatments and therapies without good evidence behind them. We need to know on a broad scale that [these tests] improve outcomes for patients, and dont just reassure physicians theyre choosing a better drug, Obley tells Managed Care.

Prasad and Obley also argued in their editorial that without further proof of improved outcomes, routine genetic testing could just fuel more inappropriate care. Guidelines carve out clear boundaries for who should get tested because there are scenarios in which the risks and benefits of preventive measures arent known, they said, noting that the U.S. Preventive Services Task Force advises against genetic testing for BRCA mutations in women without a family history of BRCA-related cancers.

A small pilot study suggests that genetic testing in primary care may not lead to improved outcomes. In 2017, The Annals of Internal Medicine published the first randomized trial of whole-genome sequencing in primary care. Gene variants were found in 20% of the participants whose genomes were sequenced. But six months later none of them had improved outcomes.

The test produces lots of information, says Obley, who wasnt involved in the study. But its not clear that any patient was managed differently in a way that improved their health.

Without evidence supporting the clinical utility of routine pharmacogenomics or genetic testing, most payers are unwilling to cover them. Some exceptions exist, such as employers that offer routine genetic testing as an employee benefit. In a blog post published in 2018, Color Genomics touted Visa and the German software company SAP as customers. Medicare covers pharmacogenomic testing of two gene variants that predict warfarin responsiveness for beneficiaries enrolled in a randomized, controlled clinical study that meets certain standards.

The high cost of genetic testing has been cited as another reason insurance coverage is limited, but payers may not budge even as testing gets cheaper. The cost of doing the test itself has been declining quite rapidly, says Kathryn Phillips, a health economics professor at University of CaliforniaSan Francisco who researches personalized medicine access, quality, and reimbursement. She has disclosed in recent studies that she is a paid consultant for Illumina, a DNA sequencing company. But she says its hardand its going to take longerto figure out where to use genetics in primary care in healthy populations, and [for insurers] to pay for it.

The current state of evidence and bleak reimbursement prospects havent deterred early adopters from embracing precision medicine in primary care. For Megan Mahoney, MD, chief of general primary care at Stanford Medicine, precision medicine begins with going after data on key determinants of healthnot just genes, but also environmental factors, social determinants, and health behaviors.

In a yearlong pilot of 50 patientsmore than half of whom were at risk for cardiovascular conditionsStanford Medicine care teams created personalized care plans to prevent and manage chronic illness. The plans leveraged data from several sources, including genetic-risk assessments and genetic testing for the three CDC Tier 1 conditions and remote monitoring devices.

Before the pilot, which ended in 2018, Stanford did not offer routine genetic testing in primary care. So far, that hasnt changed. But Stanford is making the genetic-risk assessment tested in the pilot available to its primary care providers, hoping it can increase screening rates for the Tier 1 conditions, says Mahoney. Studies show that many primary care providers are uncomfortable evaluating and addressing genetic risk. Five patients in the pilot discovered through the genetic risk screening that theyre at high risk for breast cancer, demonstrating that this type of tool can help to identify previously unknown risks.

Post-pilot, Stanford is also offering patients with poorly controlled blood pressure connection to a Bluetooth-enabled blood pressure cuff and health coaching as part of a larger study. Genetic testing has dominated the discussion of precision medicine in primary care, but Stanfords experience shows that it isnt the only way to tailor preventive care to individual patients needs.

Even if clinical utility is ultimately shown, folding precision medicine into primary care will likely follow the path of many new developments in medicine: There will be some early adopters, but most practices will have a wait-and-see and depends-on-the-reimbursement attitude.

Educating doctors on how to interpret, use, and communicate genetic testing results to patients will be one of the biggest hurdles. Theyll be learning on the job, says Susanne Haga, associate professor of internal medicine at Duke Universitys medical school, who leads educational activities in genetics and genomics for the Duke Center for Applied Genomics. An obstacle course of other possible barriers awaits: the limited number of certified genetic counselors, concerns about privacy and genetic discrimination, and the potential for the lack of diversity in genomic data sets to exacerbate disparities in care.

Still, Haga sees the convergence of three factors that will force the health care systems hand and usher in precision medicine in primary care: patients increasing ability to influence decisions about their care, the declining cost of testing, and a critical mass of people, numbering in the millions, who will have had their DNA sequenced in genome programs such as Geisingers or several national genomics research initiatives.

Its coming, she says, one way or another.

Read more:
Precision Medicine in Primary Care: Bespoke. Genetic and Genomic. And Maybe Not Ready. - Managed Care magazine

Precision medicine promises a new paradigm in oncology where every patient receives truly personalized treatment. This approach to disease diagnosis, treatment and prevention utilizes a holistic view of the patientfrom their genes and their environment to their lifestyleto make more accurate decisions.

Growing at a rate of 10.7 percent, the precision medicine market is expected to exceed $96 billion by 2024.1 Bioinformatics represent a significant share of the market, as bioinformatics tools enable the data mining necessary for rapid identification of new drug targets and repurposing of existing treatments for new indications.1 (Reuters) The oncology segment of the precision market is expected to experience an 11.1 percent compounded annual growth rate (CAGR) leading up to 2024 due to the success of recent targeted therapies and subsequent high demand.

Still, precision medicine is in its infancy, and making personalized treatment a reality for all patients requires a transformation in how novel therapies are developed and delivered. New regulatory, technical, clinical and economic frameworks are needed to ensure that the right patients are able to access the right therapy at the right time. In this article, we review the current state of precision medicine in oncology and explore some of the challenges that must be addressed for precision medicine to reach its full potential.

Great strides toward precision medicine are being made in the area of cancer immunotherapy, which is designed to boost a patients own immunity to combat tumor cells. The introduction of immune checkpoint inhibitors (PD-1/PD-L1 and CTLA-4 inhibitors) revolutionized treatment for certain hematologic malignancies and solid tumors. To date, immune checkpoint inhibitors have been approved by the U.S. Food and Drug Administration (FDA) for more than 15 cancer indications, but their widespread use has been hampered by unpredictable response rates and immune-related adverse events.

The approvals of the first chimeric antigen receptor (CAR)-T cell (CAR-T) therapies in 2017 were the next leap forward in precision medicine. These immunotherapies demonstrated that it was possible to take out a patients own T-cells, genetically modify them, and then put them back in to target cancer cells. With complete remission rates as high as 83 percent within three months of treatment, CAR-T therapies represent a seismic shift in our approach to cancer, bringing the elusive possibility of a cure one step closer. However, longer-term follow-up has shown that these remissions may not be durable2 and prevention of relapse must still be studied.

Ultimately, the goal of cancer immunotherapy is to stimulate the suppressed immune system of a patient with cancer so that it can launch a sustained attack against tumor cells.3 This is complicated, as the interactions between tumors and immune systemsometimes called the Cancer-Immunity Cycle (see Figure 1 in the slider above)4are complex and dynamic. The Cancer-Immunity Cycle manages the delicate balance between the immune systems ability to recognize non-self and the development of autoimmunity.

In some cases, the immune system may fail to recognize tumor cells as non-self and may develop a tolerance to them. Moreover, tumors have an armamentarium of methods for evading the immune system. Given this elaborate interplay between cancer and immunity, there is a wide range of potential cancer immunotherapy approaches:

The immune response to cancer involves a series of carefully regulated events that are optimally addressed as a group, rather than individually.4 The complexity of the immune response to cancer provides a strong rationale for combination therapies, for instance:

Increasingly, the development and deployment of immunotherapy relies on harnessing genomic data to identify the patients most likely to respond to immunotherapy and to customize immunotherapy for a given patient.6 Thus, molecular profiling technologies, such as next-generation sequencing, have become integral to drug development and patient selection. At the same time, researchers are focusing on identifying molecular alterations in tumors that may be linked to response.7 The molecular fingerprints of a tumor can be quite complex and heterogeneous, not only across tumors, but also within a single patient. Consequently, molecular tumor characterization requires both multidimensional data from laboratory and imaging tests and advanced software and computational methods for analyzing these data.8 This emergence of computational precision oncology is associated with both opportunities and challenges, from validation and translation to regulatory oversight and reimbursement.

The regulatory landscape is evolving to keep pace with technological advances in cell engineering and gene editing. Since 2013, the FDA has published four guidance documents on cellular and gene therapy products, as well as two guidance documents providing recommendations on regenerative medicine advanced therapies (RMATs). Specifically, their Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, published in November 2017, provides guidance on the expedited development and review of regenerative medicine therapies for serious or life-threatening diseases and conditions. This document also provides information on the use of the accelerated approval pathway for therapies that have been granted the RMAT designation.9

In the EU, the European Medicines Agency (EMA) published a draft revision of its Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells in July 2018.10 This draft revision includes current thinking on the requirements for nonclinical and clinical studies, as well as specific sections on the scientific principles and clinical aspects of CAR-T products.

Precision medicines such as CAR-T therapies require manufacturers to transform a complex, individualized treatment into a commercial product. In conventional manufacturing, the entire manufacturing process occurs within the confines of the manufacturing facility. With cell therapies, however, the process begins with the collection of cells from the patient and ends with administration of the final product (see Figure 2 in the slider above). In between, the cells are handed off multiple times for the process of genetic modification, creating a complex supply chain that blends manufacturing and administration.11

Moreover, in contrast to traditional manufacturing where the starting materials are standardized or well-defined, the starting materials for cell therapies are derived from patients and, thus, highly variable.

As evidenced by the manufacturing challenges that plagued the launch of Kymriah (tisagenlecleucel), even pharmaceutical giants have struggled with meeting label specifications for commercial use.13 To help address its manufacturing hurdles, Novartis acquired CellforCure, a contract development manufacturing organization, and plans to transform by focusing on data and digital technologies.14,15 What this means for sponsors is that robust, scalable manufacturing must be incorporated into clinical developing planning at its earliest stages.

The high price tags associated with CAR-T therapies illustrate how expensive targeted therapies are in comparison to their traditional counterparts.16 Existing health insurance models have not been structured to reimburse for costly treatments that offer the potential for long-term benefit or even cure. The pricing model for CAR-T therapies may be especially challenging for private insurance companies, which have higher turnover and shorter coverage windows than national health insurance programs. For sponsors of precision medicine therapies, one way to address the challenge of reimbursement is to create innovative, value- or outcomes-based pricing models, rather than focusing on sales volume. The success of these new pricing models will rely on patient selection. To demonstrate value and optimizing outcomes, sponsors will need to develop profiles of patients who are most likely to respond and provide tools for identifying these patients.8

Of note, on August 7, 2019, the Centers for Medicare & Medicaid Services (CMS) finalized the decision to cover FDA-approved CAR-T therapies when provided in healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) for FDA-approved indications. Medicare will also cover FDA-approved CAR-T treatments for off-label uses that are recommended by CMS-approved compendia.17

Beyond the pharmaceutical companies that are working to develop personalized treatments, the precision medicine ecosystem has a number of other key stakeholdersregulators, payers, diagnostic companies, healthcare technology companies, healthcare providers and, of course, patients. Pharmaceutical companies need to engage with each of these stakeholders by providing education or developing partnerships that help demonstrate the need for high-quality data collection, the value of precision medicine, and the process for identifying the right patients.

Sponsors may also benefit from engaging with patient advocacy groups as these groups play a critical role in connecting patients and caregivers with scientific and healthcare experts to learn about how new immunotherapy breakthroughs are changing the standard of care.

Empowered patients pushing for the latest innovations are propelling precision medicine forward, but we still have a way to go before the full potential of precision medicine is realized. In its maturity, precision medicine will not only enable the personalization of treatments for individual patients, but also inform public health at a population level as insights from the genetic and molecular data collected are used to advance our understanding of disease. Robust data collection and analysis, along with standardization, are required for building this foundation of precision medicine, and multi-stakeholder buy-in is necessary for addressing issues around data integration and privacy.

While significant challenges remain, the opportunity to transform patient outcomes and population health with precision medicine is tantalizing. Increasingly, we are seeing advanced technologiessuch as artificial intelligence and machine learningbeing incorporated into the drug discovery and development process. This underscores the critical need for a multidisciplinary approach to precision medicine, from discovery at the bench all the way through to delivery at the bedside, to help ensure that more patients can access the right therapy at the right time, and the right price.

References

Read the original here:
Realizing The Full Potential Of Precision Medicine In Oncology - Contract Pharma

Precision medicine, or personalized medicine as it is sometimes referred to, is a most significant and promising healthcare trend. The National Institutes of Health (NIH) defines precision medicine as an individualized plan that uses a patient's genetic makeup and their environment and lifestyle to deliver the right preventative advice or targeted disease treatment.

For example, precision medicine as it applies to cancer treatment might encompass:

The NIH has also started an ambitious research program designed to advance the study and applications involved in precision medicine, which can have positive ramifications for the future of medicine as a whole. The Precision Medicine Initiative is geared toward learning how genetics, environment, and lifestyle can help determine the best approach to prevent or treat disease.

Through the initiative, for example, scientists at the National Cancer Institute hope that further study of the disease's genetics and biology will lead to better life-extending treatments. The initiative's All of Us Research Program is also using the health data of approximately 1 million volunteers to study many other diseases, and improve prevention, diagnosis, and treatment stats.

Precision medicine has such a huge range of potential applications that the sky is literally the limit in terms of how it may help doctors treat virtually any disease in the future.

But right now, there are several exciting developments that you, as a physician or hospital administrator, should know about and investigate further to see if they may be appropriate for your patients' needs. These developments include:

The Centers for Disease Control has highlighted the fact that that a new small molecule drug, ivacaftor, is improving the outcomes of cystic fibrosis (CF) patients by closely targeting the specifics of why an individual patient has CF, as opposed to treating its symptoms.

Early administration of this therapy has greatly reduced the need for inpatient hospital stays and allowed patients to improve.

The CDC has also highlighted cascade screening, which means a healthcare team contacts the family members of patients with a range of conditions to interview them about and inform them about the hereditary implications of the illness they may all eventually deal with.

Then, patients who wish to be screened for genetic markers or a disease itself can do so. The information that doctors learn from a patient's relative can then be applied to treating the original patient. It's extremely important to take issues of consent and privacy into account in terms of this approach, but if done right, the benefits to patients and their families can be invaluable.

MD Anderson has set up a personalized care therapy resource website, through which any doctor can look up information on a diagnosed genetic marker and find cutting-edge info on clinical trials, disease mutations, and tumor profiling. Patients working with their doctors to better understand their conditions can use the website, too.

It's vitally important to keep up with precision medicine developments in your specialty fields and apply what is available for you as a physician or administrator right now. With precision medicine, you lengthen a patient's odds for a better outcome in so many potential ways. Just as important is that precision medicine can change the way your patients view their disease(s).

Lisa Mulcahy is an internationally established health writer whose credits include the Los Angeles Times, Redbook, Glamour, Elle, Cosmopolitan, Health, Good Housekeeping, Parade, Woman's Day, Family Circle and Seventeen. She is the author of eight best-selling books, including "The Essentials of Theater," an Amazon No. 1 new release.

Her Contemporary Authors biography is available here.

Read more:
New resources in precision medicine that every doctor should know about - MultiBriefs Exclusive

LEIPZIG, Germany and EMERYVILLE, Calif., Jan. 30, 2020 /PRNewswire/ --Profusa, a digital health company that is pioneering the next generation of personalized medicine, today announced research findings that suggest the company's Lumee Oxygen Platform may help improve the clinical management of patients with critical limb ischemia (CLI) who are undergoing endovascular revascularization treatment (EVT). The data, from a recent post-market clinical study called OMNIA (Oxygen Monitoring Near Ischemic Areas), were detailed in a series of presentations at the Leipzig Interventional Course (LINC) in Leipzig, Germany.

The Lumee Oxygen Platform is a tiny, injectable tissue-integrated biosensor with an intelligent data platform intended for continuous, real-time monitoring of tissue oxygen levels.

"Performing revascularization in patients with critical limb ischemia is standard practice, but the tools surgeons and interventionalists typically use to gauge effectiveness of the procedure are not ideal," said Marianne Brodmann, M.D., interim head of the Clinical Division of Angiology, Department of Internal Medicine, at Medical University inGraz, Austria. "These research findings from OMNIA suggest that continuously measuring tissue oxygen may result in better outcomes for these patients."

CLI is a serious form of peripheral artery disease (PAD), a condition that affects more than 200 million people worldwide and results in the narrowing of blood vessels and reduced blood flow to the lower limbs. Decreased tissue oxygen levels in the lower limbs of PAD patients can lead to disabled walking, or in more advanced cases, gangrene and amputation. CLI can result in severe pain in the feet or toes, even while resting.

OMNIA, a multicenter trial of the Lumee Oxygen Platform, monitored tissue oxygen levels in the affected limbs of 35 CLI patients who underwent EVT procedures, which are designed to clear obstructed arteries. Study participants were injected with four Lumee biosensors, three in the foot and one as a reference sensor in the arm. OMNIA collected measurements of oxygen throughout the revascularization process (with measurements performed before, during, and one, three, six, and twelve months post-procedure). OMNIA also recorded traditional hemodynamic metrics, including ankle-brachial index and toe-brachial index, and clinical assessments of wound healing at each follow-up visit.

The OMNIA data presented by Brodmann showed that increases in tissue oxygen during EVT were significantly higher in patients who experienced wound healing than in those who did not (p<0.01). In addition, tissue oxygen levels during revascularization were a better predictor of wound healing than traditional clinical measures, such as ankle-brachial index or toe-brachial index (p=0.59 and p=0.14, respectively).

"These findings show the importance of further investigating how continuous tissue oxygen measurements may satisfy an unmet clinical need to objectively evaluate how the increases in blood flow offered by EVT actually translate into nutritive oxygen delivery to the injured tissue," added Brodmann.

Martin Werner, M.D., an angiologist at Hanusch Hospital in Vienna, noted that traditional angiography during EVT does not sufficiently measure microvascular blood flow, a special concern for people with diabetes who may have microvascular impairment. He presented results of a retrospective classification analysis from OMNIA in which continuous oxygen traces measured by the Lumee Oxygen Platform were analyzed throughout EVT. Findings showed that oxygen changes between discrete time points, specifically start and end of EVT, may not be predictive of wound healing, but dynamic changes continually assessed throughout the procedure were.

"These results indicate that continuous measurements of blood flow in the foot during EVT may reveal factors that provide clues to treatment outcome that would have been missed if only measured at the start and end of the procedure," said Werner.

Stephen Kanick, Ph.D.,data science lead for Profusa, presented data from OMNIA that evaluated how Lumee biosensors assess long-term tissue viability following EVT treatments in patients with CLI. Results showed that patients who improved showed larger oxygen increases after EVT and maintained larger oxygen values at a three-month follow-up compared to patients who did not improve.

Miguel Montero-Baker, M.D., vascular surgeon and associate professor in the Division of Vascular Surgery and Endovascular Therapy at Baylor College of Medicine in Houston, discussed how tissue oxygen measured before, during and after EVT can be combined to provide a more accurate predictor of patient healing. According to Montero-Baker, "The Lumee Oxygen Platform gives us insights we have not had before about how CLI patients are responding to treatment."

"These findings from OMNIA affirm the emerging role of injectable biosensors in informing the treatment of patients with limb-threatening ischemia," said Ben Hwang, Ph.D.,chairman and CEO of Profusa. "Being able to monitor biochemical data such as tissue oxygen on a real-time basis may mean the difference between effective interventions and a catastrophic worsening of the condition."

Profusa's LumeeOxygen Platform and second-generation product, the Wireless LumeeOxygen Platform, are CE (Conformit Europenne) marked for use in the European Union. In the U.S., the Wireless Lumee Oxygen Platform is an Investigational Device limited by federal law to Investigational Use.

About ProfusaBased in Emeryville, Calif., Profusa is a digital health company led by visionary scientific founders, an experienced management team and a world-class board of directors who share the long-term goal of improving health and well-being for patients worldwide. With its long-lasting, injectable and affordable biosensors and its intelligent data platform, Profusa aims to provide people with a personalized biochemical signature rooted in data that clinicians trust and rely upon. These data may allow people to act as an active and educated participant alongside their care team and understand how their choices and decisions impact health and well-being, day-in and day-out.

"LUMEE", "PROFUSA" and the PROFUSA logo are registered trademarks of Profusa Inc. in the United States, Canada, European Union, China, Japan, South Korea and Australia.

For more, visithttps://profusa.com.

AbouttheLumeeOxygen PlatformProfusa's first clinical offering, the LumeeOxygen Platform, and the next-generation Wireless LumeeOxygen Platform, which are CE marked for use in the European Union, are indicated for use in patients with potential acute and/or chronic changes in tissue oxygen levels who may benefit from monitoring. The Lumee Oxygen sensor provides an opportunity for continuous and long-term monitoring of oxygen changes in subcutaneous tissue. After a single injection, measurement thereafter is obtained non-invasively using an optical reader. In contrast to external pulse oximeters, which measure oxygen bound to the hemoglobin in larger blood vessels, the LumeeOxygen Platform measures dissolved oxygen at the tissue level in the fluid that bathes our cells.

Contact: Sylvia ArandaW2O pure424-201-9464saranda@purecommunications.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/research-presented-at-linc-suggests-the-profusa-lumee-oxygen-platform-may-improve-clinical-management-of-patients-with-critical-limb-ischemia-300995818.html

SOURCE Profusa, Inc.

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Research Presented at LINC Suggests the Profusa Lumee Oxygen Platform May Improve Clinical Management of Patients with Critical Limb Ischemia -...

DUBLIN--(BUSINESS WIRE)--Jan 30, 2020--

The Molecular Diagnostics Market Share & Global Forecast, By Application, Technology, End User, Regions, Companies report has been added to ResearchAndMarkets.coms offering.

Increasing prevalence of Infectious diseases such as Influenza, HPV, Hepatitis, HIV and Tuberculosis despite rise in sanitation practices globally. In the past, antimicrobials medicines were used to fight powerful infectious disease but slowly in todays time antimicrobial agent is not able to give the desired results because the problem of drug resistant occurs in many people across the world.

Nowadays, a new diagnostic procedure is being followed to fight infectious disease like molecular diagnostic test is very effective which is quite fast and precise. The number of cancer patients is increasing very fast, so it is believed that in the coming time the molecular diagnostic test market will be growing at rapid pace. Global Molecular Diagnostics Market is likely to surpass US$ 22.5 Billion by the end of year 2025.

There are various reasons that will propel the market growth in forecast year; rising incidence rate of infectious disease, increasing incidence rate of cancer of all type, increasing people awareness regarding molecular diagnostic, rapid technological growth, widely acceptance of personalized medicine, rising healthcare infrastructure, increasing healthcare per capita expenditure across the developed and developing nation, accuracy of diagnosis, growing population of cardiovascular and neurological disorder etc. In addition, increasing prevalence of genetic disorder will further boost the market in forecast period of time.

The report titled Molecular Diagnostics Market Share & Forecast, By Application (Infectious Diseases, Blood Screening, Oncology, Genetic Testing, HLA (Tissue Typing), Microbiology, Cardiovascular Diseases, Neurological Diseases, Pharmacogenomics and Others), By Technology (PCR, Transcription-Mediated Amplification (TMA), Hybridiazation (In-situ Hybridiazation & FISH), DNA Sequencing & NGS, Microarray and Others), By End User (Hospitals & Academic Laboratories, Clinics and Commercial Laboratories, Others), By Regions [United States, Europe (Expect Russia), India, China, Japan, Brazil, South Korea, Mexico, Russia and ROW], Companies (Roche, Abbott, Myriad Genetics, Qiagen, BioMrieux and Others) provides a complete analysis of Molecular Diagnostics Market.

Market Insight by Application

The report provides comprehensive analysis of molecular diagnostic test market by application into ten parts: Infectious Diseases, Genetic Testing, Blood Screening, Oncology, HLA (Tissue Typing), Microbiology, Neurological Diseases, Pharmacogenomics, Cardiovascular Diseases, and Others. This report also provides key opportunities market and specific factors are given by each application market.

Market Insight by Technology

Here the market is fragmented into six parts; PCR, Transcription-Mediated Amplification (TMA), Hybridiazation (In-situ Hybridiazation & FISH), DNA Sequencing & NGS, Microarray and Others. Besides, many factors are analyzed that influence the growth, challenges and opportunities of market in technological context.

Market Insight by End User

The report provides complete insight of market by End User segments: Hospitals & Academic Laboratories, Clinics & Commercial Laboratories and Others. According to the publisher, Hospitals & Academic Laboratories will hold the largest market in global molecular diagnostic test market in forecast period of time.

Market Insight by Regions

This report covers the complete regional profile by 10 geographical market; United States, Europe, India, China, Japan, Brazil, South Korea, Mexico, Russia and Rest of World (ROW).

Key Topics Covered:

1. Executive Summary

2. Global Molecular Diagnostic Market

3. Market Share - Global Molecular Diagnostics

3.1 By Application

3.2 By Technology

3.3 By Countries

3.4 By Companies

4. Application - Molecular Diagnostics Market

4.1 Infectious Diseases

4.1.1 Hospital Acquired Infections (HAI)

4.1.2 HIV / HCV Testing

4.1.3 STD Testing

4.1.4 HPV Testing

4.2 Blood Screening

4.3 Oncology / Cancer

4.3.1 Breast

4.3.2 Colorectal

4.3.3 Prostate

4.3.4 Others

4.4 Genetic Testing

4.5 HLA (Tissue Typing)

4.6 Microbiology

4.7 Cardiovascular Diseases

4.8 Neurological Diseases

4.9 Pharmacogenomics

4.10 Others

5. Technology - Molecular Diagnostics Market

5.1 PCR

5.2 Transcription-Mediated Amplification (TMA)

5.3 Hybridiazation (In-situ Hybridiazation & FISH)

5.4 DNA Sequencing & NGS

5.5 Microarray

5.6 Others

6. Region - Molecular Diagnostics Market

6.1 United States

6.2 Europe

6.3 India

6.4 China

6.5 Japan

6.6 Brazil

6.7 South Korea

6.8 Mexico

6.9 Russia

6.10 Rest of World (ROW)

7. End Users - Molecular Diagnostics Market

7.1 Hospitals & Academic Laboratories

7.2 Clinics and Commercial Laboratories

7.3 Others

8. Roche Diagnostics - Company Analysis

8.1 Merger & Acquisitions

8.2 Sales Analysis

9. Abbott Laboratories - Company Analysis

9.1 Merger & Acquisitions

9.2 Sales Analysis

10. Myriad Genetics - Company Analysis

10.1 Merger & Acquisitions

10.2 Sales Analysis

11. Qiagen - Company Analysis

11.1 Merger & Acquisitions

11.2 Sales Analysis

12. BioMrieuxs Inc - Company Analysis

12.1 Merger & Acquisitions

12.2 Sales Analysis

13. Market Drivers

13.1 Various Developments in the Molecular Diagnostics Landscape

13.2 Integral to Traditional Labs

13.3 Improved Assay / Test Efficiencies

13.4 Targeting Antibiotic Resistance

13.5 Next Generation Ultrasensitive Molecular Diagnostics

13.6 Increasing Investment in Genomics & Proteomics Research

13.7 Technological Advances in Molecular Diagnostics

13.8 Increasing Acceptance of the Personalized Medicine

13.9 Growing Molecular Diagnostics for Food Safety

14. Challenges

14.1 Dearth of Trained Professionals

14.2 Regulatory Issues

14.3 Various Factors Slowing Growth of Molecular Diagnostics

14.4 Reimbursement Capabilities

14.5 Quality Checkpoints, Awareness & Acceptance

For more information about this report visit https://www.researchandmarkets.com/r/j3on5s

View source version on businesswire.com:https://www.businesswire.com/news/home/20200130005474/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

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Global Molecular Diagnostics Market is Likely to Surpass US$ 22.5 Billion by the End of Year 2025 - ResearchAndMarkets.com - Associated Press

As we herald in the new decadeone that will be entirely driven by digital transformation and the agile integration of innovative technology at a rapid paceenterprises across the board are re-evaluating their internal and external operations from the ground up. In the past decade, we have witnessed new technologies come to lifefrom cloud and edge capabilities, blockchain, to 5G connectivity and beyond. Industries are fighting tooth and nail to bring these technologies first-to-market, and oftentimes expand upon the previously-determined boundaries of what purposes these technologies were built to serve.

Were at a vital turning point as we enter 2020, where organizations across all industries must not only continue to integrate innovative technology into their internal and external operationsthey must reimagine their businesses entirely and rebuild their foundational infrastructure to adopt agility and the ability to pivot on a dime, for when the next big technological advancement undoubtedly rises to the surface.

The healthcare industry is no different.

To date, the healthcare industry has been actively digitizing at a rapid pace. In fact, a recent study shows that a whopping 84 percent of U.S. based healthcare organizations utilize digital health records.

The benefits of this investment alone have been far-reaching. Those healthcare organizations that have switched to digital health records deliver better patient care, provide patients with better outcomes on an individual basis, improve the workplace experience for staff members, and even are able to offer cost-efficient healthcare servicesall in comparison to their non-digital counterparts.

Over the next decade, these organizations will not only continue to reap the benefits of their pre-existing digital transformation efforts but will begin to significantly invest in other next-gen technologies and capabilities to continue to bring new, innovative patient care solutions to the reshaping and hyperconnected healthcare ecosystem.

Digital Capabilities will BlossomThere have already been significant advancements in digital capabilities, beyond simply digitizing records. Healthcare leaders have successfully implemented other capabilities, such as remote and self-monitoring medical chatbots, smart pills, implants and more. Such innovation is a direct reflection of the highly-advanced levels of digitalization throughout the industry.

That being said, wider adoption of AI and automation has yet to be fully realized. In fact, only a mere 33 percent of U.S. healthcare organizations have adopted AI technology. Thats not to say that the ambition for adoption isnt there. Back in 2018, over half of healthcare professionals believed that by 2023 there would be widespread AI adoption throughout the industry.

Going into 2020, we expect to see these ambitions become fully realized. AI is becoming increasingly mainstream in all aspects of patient carefrom the overhaul of triage and administrative capabilities to diagnostics and beyond. It can then help doctors understand more about a patient, through the strategic analysis and activation of pre-existing patient data.

Personalized Medicine will ThriveOur experience is that more than two-thirds (75%) of life sciences and healthcare organizations can customize products and services to almost every single interaction. This is an amazing feat for the industry at largeespecially when considering the lack of AI investment to-date.

We will see these capabilities continue to grow in 2020, as personalized medicine becomes increasingly high-tech and data-driven. As AI becomes increasingly ingrained in the process of personalized and precise medicine, the personalized solutions that are developed will become smarter, more specific and more custom-tailored than ever previously imaginable.

Furthermore, in 2020 medical implants will become increasingly agile and be able to perform more functions to minimize patient input for treatment. Bioprinting tech will bring prosthetics and stent technology to new heights as wellas new materials and build processes become fully-realized. The aforementioned bio- and precision-tech will make medical implants significantly less invasive and safer than ever before.

While these personalized capabilities are certainly not new to the industry, a majority of Americans are not familiar with what personalized medicine even is. Additionally, those who are familiar express tend to express concern over the cost of personalized care, and increasingly other elements such as privacy and data concerns. As medical-tech and digital transformation further push personalized care to new heights, there will also be a significant effort to inform the public about what these solutions are, how they are beneficial to patients and how they can remain affordable as well.

The healthcare industry is at a significant turning point. While digitizing records has been a focal point for industry players in the past, investment in next-gen technology will become bolder and more widespread. AI will play an integral role in helping healthcare organizations take a leap of faith toward becoming fully-digital, hyper-connected and mass-personalized. Its an exciting time to work within the healthcare industry, and a hopeful time for patients who will have access to smarter, better and more personalized patient services at lower cost.

Photo: Andreus, Getty Images

See original here:
Transforming healthcare practices and patient care in the digital era - MedCity News

1. Siloed Data Is an Opportunity Lost

Data of all types clinical, financial and operational remain siloed for reasons that range from interoperability issues to legacy systems. This becomes further complicated when redundancies are created through mergers (such as multiple electronic health record systems, enterprise resource planning solutions and enterprise imaging systems).

In addition, payers and providers alike continue to struggle with mining unstructured data for clinical and business insights. For example, the Centers for Medicare and Medicaid Services (CMS) calibrates payments to Medicare Advantage plans based on plan population health as determined through diagnosis codes that identify chronic conditions.

Patient conditions, however, are often not included in the codes captured on claims. As such, payers must conduct a tedious exercise each year to retrieve additional data, sometimes from printed medical charts, to fill in the gaps.

The bottom line: Unused data is an opportunity missed in an industry where resources are stretched increasingly thin, especially when it comes to advancing quality of care and establishing new revenue streams.

Precision medicine has been an extraordinarily important quest for the healthcare community. We are now, at long last, making steady and measurable progress in leveraging genomics to improve outcomes.

In cancer care, for example, it is becoming routine to analyze tumors for known gene mutations or expressions to select treatments likely to be most effective. Yet, despite its tangible benefits, the application of precision medicine, specifically in cancer care, still presents significant challenges. This approach can be expensive, invasive and time-intensive as tumors are analyzed through traditional pathology and genomics.

Increasingly, AI-enabled imaging presents a powerful opportunity to accelerate the identification and application of personalized treatments in ways that are often less invasive, faster and potentially more cost-effective. In the past few years, weve started to see several promising applications of AI in imaging to support precision medicine initiatives.

A study published in the Journal of Neuro-Oncology in April 2019 shows strong potential for using machine learning algorithms to reveal multimodal MRI patterns to accurately and rapidly predict the presence of genotypes and mutations in glioma specifically, isocitrate dehydrogenase (IDH) and 1p19q codeletion status which are good predictors of treatment efficacy.

There has also been substantial progress in AI screening for breast cancer, as shown in this recent study published by Nature in January 2020. These are just a few examples, and the potential for others is limitless.

There are a number of factors at play. First, in our daily lives, weve all come to expect unlimited access to information and services whether online or from our mobile phones. These expectations are now carrying over to our healthcare experience.

At last years HIMSS conference, Dr. Donald Rucker, national coordinator for health IT told attendees, Its long overdue for the healthcare industry to be a part of the smartphone economy and enable patients to access their health data through an app of their choice, at no additional cost.

Giving patients access to their data through mobile devices and apps can drive increased levels of patient engagement and better empower their decision-making. In line with expanding expectations for sharing data with patients, CMS has finalized a rule focused on streamlining patient access to health data.

It is also possible that patients expanded access to their health information might help to fuel nascent interest in crowdsourcing of chronic disease data, which could someday present a wealth of information that clinicians and researchers have struggled to access easily.

HIMSS20: Follow us on Twitter as we gear up for the biggest health IT conference of the year in March.

Even as progress accelerates, the industry continues to face challenges as it works to unlock the greatest value from healthcare data. These include hurdles associated with interoperability, security and privacy as technologies advance faster than policy can keep pace.

Healthcare organizations and payers cannot afford to wait for perfection. Instead, they can make solid advances today that will enable them to accelerate at pace with patient expectations, regulations and technology. It all starts with a data foundation that can support the modern data experience that healthcare organizations and consumers crave.

Creating this new type of data experience requires a new type of data hub one that allows organizations to consolidate their systems on a single platform to unify and share data across applications for better insight. Rather than acting as merely a data repository, the data hub must be able to share and deliver data within an organization for modern analytics and AI so patients and clinicians can benefit from the analysis.

As we enter this data decade, the future is bright for healthcare organizations and the patients they serve. By embracing a modern data experience and building a foundation that ensures its success researchers, providers and payers will be well positioned to improve patient outcomes and elevate operational proficiency in the years to come.

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It's All About the Data in 2020 and Beyond - HealthTech Magazine