StemCell Therapy

It has been predicted that the COVID-19 pandemic would cause business disruption. Now, it has claimed a casualty with Second Sight Medical Products Inc., of Sylmar, Calif., which has been forced to wind down operations, citing the pandemic and the impact it will have on the companys ability to secure financing. Second Sight, which makes the Argus II retinal prosthesis system, said that effective March 31, 84 of its 108 employees will be laid off.

The company expects to bring on an adviser experienced in winding down operations to guide the board on next steps. However, additional layoffs are anticipated in the future based on the companys level of operations.

When asked whether it was looking for buyers for its Argus II/Orion assets and if it could predict how long the wind down would take, the company referred BioWorld to its statement and 8-K filing.

With the wind down announcement came news that the company had named Matthew Pfeffer, chairman of the audit committee of the board, as acting CEO, effective immediately. News of the companys winding down comes roughly three weeks after it reported that Will McGuire, president and CEO, was leaving, effective March 27. He was slated to remain as a director on Second Sights board.

McGuire left to join Carlsbad, Calif.-based Ra Medical Systems Inc. as CEO and a member of the companys board, effective March 30, citing the desire to be closer to his family.

With McGuires departure, Gregg Williams, the board chair, was tapped as acting CEO. However, now the company has decided to go with Pfeffer through this process.

Orion

Before the decision to wind down, the company had high hopes for its Orion visual cortical prosthesis system. The company saw the potential for the product to provide useful artificial vision to individuals blind from many causes, such as glaucoma, eye injury, diabetic retinopathy, optic nerve disease or injury and retinitis pigmentosa.

Indeed, during the companys March 19 fourth-quarter earnings call, COO Pat Ryan provided an update on the companys Orion early feasibility study. Specifically, it had wrapped up the 12-month testing for the sixth and final subject in February. Ryan detailed some results, noting that on square localization, 83% of individuals scored significantly better with the device on than off. All individuals scored significantly better with the device on than off on direction of motion.

From a safety perspective, as previously shared, there was one serious adverse event in seven nonserious adverse events over the same time period. These results are extremely encouraging, and we believe sufficient to support moving forward with a pivotal study in the U.S., Ryan said.

The company had reached an agreement with the U.S. FDA on the primary efficacy endpoint for the pivotal trial, which will be FLORA [Functional Low Vision Observer Rated Assessment] 20. As of that date, three of 15 subjects have begun participation in the FLORA 20 validation. However, due to COVID-19 social distancing protocols, we have suspended validation efforts until further notice, he said at the time.

Kyle Bauser from Dougherty & Co. asked whether COVID-19 had had an impact on the IDE application, given that it was now slated for the first half of next year. Ryan said no, adding that the company was being conservative in light of ongoing discussions with the FDA.

Competition

For its part, a big competitor of Second Sight, Paris-based Pixium Vision SA, reported March 31 positive follow-up data from a feasibility trial of the Prima system in patients with dry age-related macular degeneration (AMD). Specifically, the Prima system sustainably elicited light perception in all four dry AMD patients with favorable safety profile. The company said the results build on the previously reported positive 12-month clinical data. The Prima system is intended to partially replace the normal physiological function of the eyes photoreceptor cells by electrically stimulating the nerve cells of the inner retina. Those then transmit the visual information to the brain via the optic nerve.

But COVID-19 is having an impact on this company as well. Pixium reported March 23 that it had decided to postpone continuing its feasibility studies in France and the U.S., aside from ongoing safety monitoring. It added that the initiation of the PRIMAvera pivotal study with the Prima system in dry AMD may be delayed.

See the rest here:
Citing COVID-19, Second Sight to wind down operations - BioWorld Online

ACCORDING to the Health Ministry, at least 80% of all blindness or limited vision cases can be prevented or treated.

A national eye survey in 2014 showed that at least 1.2% or 63,000 Malaysians have been diagnosed as blind.

To address this, the role of eye care specialists has taken on significance in fighting preventable vision impairment.

There is much more than meets the eye when it comes to the role of an eye care specialist beyond just examining your eye and prescribing lenses.

An optometrist not only helps you see clearly and detects signs of eye disease, but also assesses how well your visual system which encompasses the eyes, brain and eye muscles work.

The World Council of Optometry (WCO) states that optometrists provide comprehensive eye and vision care, which includes refraction and dispensing, detection and diagnosis, management of eye disease, and rehabilitation of the visual system conditions.

The importance of eye care specialists be it an optician, optometrist or ophthalmologist is imperative and crucial to the general healthcare of patients in need of eye care.

The need for optometrists in Malaysia is worrying. At present, there are over 2,000 optometrists and the ratio of optometrist to patient stands at around 1:22,000. The WCO recommended ratio is 1:10,000.

As such, UCSI University Malaysias best private university for two years in a row according to the two recent QS World University Rankings offers the Bachelor of Optometry (Hons) programme to play its role in creating more eye care specialists.

Optometrists are naturally high-income earners with tremendous potential for growth, job security and satisfaction.

During clinical trainings, students at UCSI learn in a simulated optometric environment.

A career in optometry is virtually stress-free and not physically demanding. During clinical trainings, UCSI students learn in a simulated optometric environment, practising on each other before moving on to real patients, under the supervision of experienced lecturers.

This training provides procedural experiences in case history taking, performing eye examinations, employing diagnostic techniques and applying the necessary communication skills to discuss treatment plans and options with patients.

Not all graduate studies are scientific theories; many are very practice-oriented. Students in their final year will be able to manage a practice and work with children and the elderly with a clear knowledge of healthcare laws and policies, ethics and economics that are applicable to the field of optometry.

Asst Prof Shah says optometry is a rewarding career for those who are prepared to care for people to see clearly.

UCSI Universitys head of Optometry School Asst Prof Shah Farez Othman pointed out that optometrists, upon completion of the programme, develop specific interests to advance in other eye care areas such as contact lens practice, low vision, sports vision, childrens vision and consultancy in an industry.

Optometry is a rewarding profession for those prepared to accept the obligation of caring for peoples sight. Optometrists enjoy great satisfaction through helping their patients overcome vision problems, he said.

The four-year optometry programme at UCSI follows guidelines set by the WCO and is fully accredited by the Malaysian Qualification Agency (MQA).

The four-year optometry at UCSI follows guidelines set by the WCO and is fully accredited by the Malaysian Qualification Agency (MQA).

Graduates from this programme will enter the workforce as an optometrist registered with the Malaysian Optical Council, Health Ministry, giving them an edge to secure jobs much easier.

For more information, visit http://online.ucsiuniversity.edu.my/ or email your queries to info.sec@ucsiuniversity.edu.my

Continued here:
Through the lenses of an eye care expert - The Star Online

Executives at Second Sight, the Nasdaq-listed company that has developed a series of implants designed to restore a form of vision to blind people, have decided to wind down the companys operations with immediate effect.

The decision comes after attempts to secure additional financing were hindered by the global coronavirus pandemic. Second Sight says 84 of the companys 108 employees were laid off March 31, with additional layoffs expected in the future.

It also means that company chairman Gregg Williams, who had been appointed acting CEO of Second Sight less than a month ago, will not now take up that role. Instead Matthew Pfeffer, chairman of the Second Sight boards audit committee, will lead the company through the wind-down period.

Economic shockSaying that its laid-off employees will be eligible for unemployment benefits subject to local regulations, Second Sight added in a company release:

Against a background of unprecedented economic shock caused by the Covid-19 pandemic and inability to secure additional financing, the companys board of directors has evaluated strategic alternatives and decided to pursue an orderly wind down of the companys operations.

News of the wind down came less than two weeks after the Los Angeles firm revealed its financial results for fiscal year 2019. Those figures showed an operating loss of $34million during the year, on sales of less than $4million.

That meant Second Sight had burned through much of the $35million cash that it had raised in a shareholder rights issue just over a year ago - the vast majority of which had been provided by Gregg Williams.

As of the end of last year the company had held just over $11million in cash and equivalent assets, but with a quarterly burn rate typically in the region of $8million that pile is likely to have dwindled over the past three months.

JHU collaborationLast October the firm secured a $2.4million grant from the National Institutes of Health. It was awarded to fund a four-year collaboration with researchers at Johns Hopkins Universitys Applied Physics Laboratory, with the aim of integrating spatial localization and mapping technology with a future generation of Second Sights Orion visual implant.

By-passing both the eye and the optic nerve, the Orion implant is placed directly onto the visual cortex of the patient's brain. Signals received from a miniature camera integrated within a pair of glasses are fed to the implant and interpreted as "vision" by the brain.

Prior to Orion, Second Sight had developed the "Argus" and "Argus II" implants, which were attached to the rear of a patient's retina. To date, more than 350 patients have received an Argus II implant.

The Orion implant is currently the subject of an ongoing feasibility study with six blind patients, in collaboration with the University of California Los Angeles' Ronald Reagan Medical Center, and the Baylor College of Medicine in Houston, Texas.

Second Sight had been working towards a larger pivotal trial of the Orion implant, while all of the patients taking part in the small-scale study had reached the 12-month mark.

Company COO Pat Ryan had said last month: It is gratifying to know that this device can help profoundly blind individuals gain some independence and participate once again in certain activities of daily life. We look forward to making continued strides in advancing this breakthrough technology.

Since then, however, the companys stock price has lost around 80per cent of its value, amid the wider sell-off in stocks in response to the global coronavirus crisis.

Video: Second Sight study at Baylor College of Medicine

See the original post:
Second Sight to wind down on Covid-19 impact - Optics.org

Date: 31 March 2020

Alastair Lockwood, ophthalmologist and eye health specialist at Feel Good Contacts, explains what measures company car fleet managers can take to ensure the vision of their drivers is up to scratch.

Having good eyesight is a legal requirement for UK drivers, in fact more than 2,800 people have failed their practical testin the last five years alone before even getting into the car due to failing the 20m registration sight test. However, it's crucial that license holders ensure they have their eyes regularly checked to ensure they are up to standard and it's imperative that fleet managers encourage any drivers within their business to make a conscious effort to look after their eyes.

While legislation is in place to ensure drivers don't spend more than nine hours a day on the road, it's integral that regular breaks are taken throughout any long journeys to avoid tired, dry, and strained eyes. Ensure there are clear notices and guidance in place for your drivers within your place of work, and if you have a regular set of vehicles, somewhere within the car as well.

When driving, it is advised that drivers blink regularly, particularly when on long stretches of road that offer little stimulus to the individual controlling the vehicle. Drivers can also use the '20-20-20' rule when safe to do so: take a 20 second break from your line of sight to look at something 20 feet away every 20 minutes. This will give your eyes a chance to rest and is an effective way to reduce eye strain.

Smoking exposes your eyes to high levels of oxidative stress and has been linked to the risk of cataracts, glaucoma, diabetes, and dry eye syndrome, all of which can have long term health implications and on road safety in the process.

Quitting smoking at any stage of life can be beneficial, reducing the risk of developing eye threatening conditions. Encouraging staff to quit smoking and pointing them in the direction of relevant schemes is an excellent way to maintain greater levels of vision both on and off the road.

Driving when tired or not 100% alert will lower response time and control over the wheel. Certain medications may also be made with a drowsy formula and significantly reduce your ability to drive safely so it's important to check this with any new employees or staff that might require a vehicle.

This may sound obvious but ensure your fleet is regularly cleaned.

Before setting off, ensure the driver checks their line of sight and that mirrors are clean of any dirt and smudges, to ensure a clear field of vision. Keep windows clean to avoid increased glare and condensation.

If your staff are regularly on the road, exposure to ultraviolet (UV) light can cause eye health problems. It's important to ensure that all employees wear appropriate eye protection throughout the year. Fast fashion retailers do not always produce sunglasses with the correct materials to avoid harmful UV light. You should make workers aware that glasses with appropriate UVA and UVB protection are important and polarised glasses can be a great option for this to reduce glare caused by reflections from hoods, windows and mirrors.

Even if your staff are doing all of these things to look after their eyes, it's crucial that they take regular eye examinations to help spot sight loss or damage at an early stage. Optometrists can help detect conditions such as cataracts, glaucoma, and age-related macular degeneration, so encouraging your staff to make regular visits to the optician is an important step in maintaining good eye health.

Simple measures such as posters around the office or sending regular reminders in the form of an internal newsletter can be an easy way to promote staff checks.

Continue reading here:
Alastair Lockwood's blog: Are your drivers' eyes ready for the road this summer? - BusinessCar

Now that people are working from home, lots of time is spent looking at screens and that could cause eye strain. It could be your phone, tablet, laptop or TV. The problem lies in the fact that theres no break from when you sit down to when you finally get up.

Your health is important. So lets understand this and how we can prevent it.

Perhaps when you were growing up, your parents limited the amount of television you watched because they thought it would hurt your eyes. African parents are too guilty of this one. Personally, everything that went wrong was because of uko kwa hio simu sana (you spend too much time on your phone).

Either I didnt finish my homework, or I lost something. It was all due to the phone. Theres a time I got a stomach ache and somehow it was roped into using my phone. I thought that was a bit extreme but It was and is taboo to argue with your mother so I refrained from declining the claims.

Its only natural then that some of you warned your own children to not to do the same. According to experts, staring at the computer, tablet, and smartphone screens will not permanently damage your eyesight. However, doing so can cause some bothersome side effects. Most notably computer vision syndrome (also called digital eye strain).

The most common signs ofComputer Vision Syndrome include:

You could also suffer from glare. Simply put, glare occurs when too much light enters your eye and interferes with your eyes ability to manage it.

If you suffer from any of these symptoms, follow these few steps the next time you sit down to work.

Also, regular short breaks can help to keep you energized and focused. Try setting a countdown timer while you do an hour of work. When the alarm goes off, reward yourself with a five- or 10-minute break. You could make coffee or get some fresh air. Its vital that you get out of your chair during the day.

Excerpt from:
Best Practices To Prevent Eye Strain and Fatigue While Working From Home - Gadgets Africa

Three Keck School of Medicine professors created Argus II retinal prosthesis systems, an implant that helps patients who have become blind by retinitis pigmentosa. With the grant, the team looks to create a new device to prevent vision loss. (Daily Trojan file photo)

Inspired by his life research in retinal prosthesis, co-director of the Roski Eye Institute Mark Humayun is in the early stages of developing retinal contacts that could prevent or slow down vision loss. Humayun, along with a team of experts that includes Keck School of Medicine Provost Gianluca Lazzi and assistant professor of translational genomics Bodour Salhia, won an award of nearly $2 million from the National Science Foundation Emerging Frontiers in Research and Innovation to further research on the contacts.

As a Keck professor of ophthalmology and director of the USC Ginsburg Institute for Biomedical Therapeutics, Humayuns idea for retinal contacts came from his prior work in vision restoration. Humayun invented Argus II retinal prosthesis systems, an implant behind the eye that helps restore vision to blind patients with retinitis pigmentosa, a genetic disorder where the retinal cells at the back of the eye start to break down and become damaged.

[The grant] led us to consider this approach to try a controlled electrical stimulation to see if we could slow down or even prevent vision loss from certain types of retinal degeneration and retinal diseases, Humayun said.

The purpose of retinal research and lens device creation is to develop preventative measures for patients who are at risk of becoming blind from these diseases, whereas the Argus II treats patients after theyve already gone blind. The team of experts plans to continue this in their research funded by the grant.

The first step is to really demonstrate whether true utilization of this device through electrical stimulation will in fact result in meaningful slowing of neuron loss, Lazzi said.

The device also induces indirect electrical pulses that activate the remaining neurons in the retina. After working with Lazzi and finishing final tests, Humayun trained numerous surgeons on how to properly install the Argus II implant behind the eye. Approved by the Federal Drug Administration in 2013, the system became the first approved artificial retina system and has been commercially released through Second Sight, a medical prosthetics company for neurostimulation devices.

For more than 20 years, Lazzi has been part of the development team for Argus IIs hardware, ensuring its electronic functionality while implanted behind the eye. Lazzi said Argus II activates similarly to a scoreboard where hundreds of LED lights behind the eye turn on and off to display a partial image the blind patient sees by targeting certain points in the retina.

From his previous work in the bioelectromagnetic field, Humayun was able to develop the idea to use electrical stimulation to restore vision to people who are blind while Lazzi designed electrodes that would be placed on the retina to ensure the electronics used work properly in the eye.

The engineering work for the project has proved challenging because contacts were composed of electronic systems that pose a safety risk and may be damaged when submerged in the salty vitreous humor of the eye, Lazzi said. The issues have since been resolved by having electric currents and wireless transmissions strictly regulated in a casing.

Humayun also reached out to colleague Salhia in 2018 to ask her to collaborate on the project based on her translational genomics labs research with rat retinas that have degenerative diseases. Through this work, the team was able to show that electrical stimulation to the retina caused changes to genes associated with neuroprotection that maintains the structural integrity of neurons, which aids in preventing cell death.

The beauty of the project lies in how three groups from very different backgrounds basically come together to solve a problem, Salhia said. Its been one the funnest and most exciting and most innovative projects that Ive recently engaged in because its just so highly interdisciplinary and people from very different backgrounds are coming together to solve a problem.

Although the team of three has just begun its research for a new vision device with the funds provided from the grant, its members have already seen encouraging results in Salhias research on rat retinas and are looking forward to continuing their work to help patients in the coming years.

We have this grant for three years, so we hope to be in a pretty good position, Humayun said. In three years, we hope to be pretty far along in all these aspects as to whether we would be ready to do human studies.

Read more:
Keck professors receive grant to further retinal research - Daily Trojan Online

Many of you might be having difficulty with eyesight; it could be a reading disorder or issues with viewing objects placed at distant. When things appear hazy, blurry or double, then its time to ring the bells. Blessed are those who have only one eyesight disorder, but the problematic condition is with those who have both nearsightedness and farsightedness along with prism or astigmatism and are not used to Varifocals.

What are Varifocal Glasses?

Varifocal glasses can be considered as the advanced version of bifocal glasses, wherein there are not two but three different zones of viewing the objects from one single lens. This means the upper portion of the glass lens is designed to correct nearsightedness and clear distant objects, the lower portion is engineered to correct farsightedness whereas the middle portion of the lens provides intermediate vision clarity. The unique part about the varifocal glasses is that although there is a smooth transition from one zone of the lens to the other, there is no visible line that distinguishes three different zones.

Is it hard to get used to Varifocals?

The answer lies with the user. This is because some of the users find it easy to get used to varifocals, whereas some may find it difficult to adjust to the new pair.of glasses initially. Generally, it is observed that it takes 2 to 4 weeks to get acquainted with the varifocal glasses.

When the user begins with the varifocals, truly it is not an easy job to view through three different vision correction portions of the lens. The user may experience all or any of the following issues while starting with the new pair of Varifocal glasses:

Why it is hard to get used to Varifocals?

The reason for the user to find it hard while initiating the use of Varifocals is that our brain is habitual to either not wearing glasses or wearing single vision or bifocal glasses. Therefore, the focus of the eyes is also fixed as per the previous glasses. With the new varifocal glasses, the brain needs to re-program the routine as per the focal points of the varifocal glasses. As the user starts wearing the varifocal glasses on a regular basis, the brain, as well as the eyes, becomes used to the new pair.

How to manage and get used to Varifocals?

The only trick to get used to the Varifocal is to wear them as much as you can. Regular usage of the varifocal glasses will help the user in practicing as well as identifying the focal points of the lens. Besides, never go back to using your old pair of single or bifocal lenses, as this will only exaggerate the problem for the user. Therefore, strictly follow to wear your new varifocal glasses, as much as you can. Whether you are reading, cooking, watching TV, playing, just remember to put your glasses on. It is advised not to drive initially as there could be a high probability of misjudgment and the driver may not be able to focus clearly on the road.

Where can I buy varifocal glasses online in the UK?

You can buy one of the best pair of varifocal glasses online from Specscart and also at their stores in Walkden and Bury. Specscart manufactures the highest quality eyeglasses with affordable price tags. The varifocal glasses crafted by Specscart are digitally advanced to provide enhanced visual clarity. These glasses are already loaded with anti-glare and anti-UV protection properties and are offered free of cost. Besides, you can also opt for the anti-blue light coating on the glasses. The smooth transition from one zone to another is the essence of varifocal glasses that are highly maintained by Specscart at its state of the art laboratory.

Regarding the quality and designs of the frames for varifocal glasses online, Specscart does not compromise on the quality, colour, pattern, design and brands of the eyeglasses frames. You will get hundreds of attractive specs frames to choose from for your varifocal glasses. If selecting frames online is not your cup of tea, then try glasses at home to choose the one that suits you.

So log on to Specscart to find out which pair of varifocal glasses suit your personality and enter your latest prescription to get the fastest dispatch of glasses at your doorstep.

Read the original here:
Is it hard to get used to Varifocals? - Scubby

Keep yourself up-to-date with latest market trends and maintain a competitive edge by sizing up with available business opportunity in Global Single vision Lenses Market various segments and emerging territory. Advance Market Analytics recently introduced Global Single vision Lenses Market Report tracks the major market procedures including Market Overview, Business Revenue, Introduction, Gross profit & business strategies opted by key market players. The report also focuses on market size, volume and value, shipment, price, interview record, business distribution etc. These data help the consumer know about the competitors better. It also covers different industries clients information, which is very important to understand the market

The major players in Global Single vision Lenses Market:

Carl Zeiss AG (Germany),Essilor International S.A. (France),Hoya Vision Care Co. (Thailand),Rodenstock GmbH (Germany),Nikon Corporation (Japan),Shamir Optical Industry Ltd. (United States),CooperVision Inc (United States),Vision Rx Lab (India),SIGMA Corporation (Japan),Marchon Eyewear (VSP Australia) (Australia)

These major players have adopted various organic as well as inorganic growth strategies such as mergers & acquisitions, new product launches, expansions, agreements, joint ventures, partnerships, and others to strengthen their position in this market.

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What is Single vision Lenses?

Single vision lenses have just one prescription and feature a single field of vision or one power throughout the entire lens suitable for correcting myopia, hyperopia, and astigmatism. Thes lenses are used for reading purposes, as the problems with eyesight and awareness of eye health increasing the global single vision lenses market are also increasing. The introduction of IoT related technology in lenses is continuously increasing the market. However, the problem associated with side effects and maintaining the lenses might be the problem for the market

Market Drivers:

Increasing Prevalence of Weak Eyesight in Youngsters

Growing Awareness about Eye Health

Market Trends:

Adoption of IoT Based Advanced Single Vision Lenses

Introduction of Sports Single Vision Lenses

Market Challenges:

Lack of Proper Resolution and Fitting can be the Market Hindrance

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Consumer Traits (If Applicable)

The regional analysis of Global Single vision Lenses Market is considered for the key regions such as Asia Pacific, North America, Europe, Latin America and Rest of the World. North America is the leading region across the world. Whereas, owing to rising no. of research activities in countries such as China, India, and Japan, Asia Pacific region is also expected to exhibit higher growth rate the forecast period 2019-2025.

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In short, the report is a vital guide for understanding the Global Single vision Lenses industry accomplishments to the extent each significant perspective like all around learning of the genuine players and benefactors influencing the Global 11691 Market advertise. The examination moreover bases on current Global Single vision Lenses point of view, bargains edge, inconspicuous components of the Global Single vision Lenses showcase movement.

Key highlights of the Study:

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There are 15 Chapters analyzing in detail about Global Single vision Lenses market.

Chapter 1: to describe Global Single vision Lenses Introduction, product scope, market overview, market opportunities, market risk, market driving force;

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Chapter 5, 6, 7, 8 and 9: to analyze the key regions, with sales, revenue and market share by key countries in these regions;

Chapter 10 and 11: to show the market by type and application, with sales market share and growth rate by type, application, from 2012 to 2023;

Chapter 12: Global Single vision Lenses market forecast, by regions, type and application, with sales and revenue, from 2018 to 2023;

Chapter 13, 14 and 15: to describe Global Single vision Lenses sales channel, distributors, traders, dealers, Research Findings and Conclusion, appendix and data source.

Finally, this report covers the market landscape and its growth prospects over the coming years, the Report also brief deals with the product life cycle, comparing it to the relevant products from across industries that had already been commercialized details the potential for various applications, discussing about recent product innovations and gives an overview on potential regional market shares.

Key questions answered

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Advance Market Analytics is Global leaders of Market Research Industry provides the quantified B2B research to Fortune 500 companies on high growth emerging opportunities which will impact more than 80% of worldwide companies revenues.

Our Analyst is tracking high growth study with detailed statistical and in-depth analysis of market trends & dynamics that provide a complete overview of the industry. We follow an extensive research methodology coupled with critical insights related industry factors and market forces to generate the best value for our clients. We Provides reliable primary and secondary data sources, our analysts and consultants derive informative and usable data suited for our clients business needs. The research study enable clients to meet varied market objectives a from global footprint expansion to supply chain optimization and from competitor profiling to M&As.

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Heres How Single vision Lenses Market to Flourish with Significant CAGR by 2026 | Biggest Opportunity of 2020 - The Fuel Fox

Documentary "Human Nature" examines how gene editing can help - and hurt - humanity.

If youre familiar with the Replicates from Blade Runner, the velociraptors from Jurassic Park or the genetic engineering so chillingly laid out in Aldous Huxleys novel Brave New World, youll be fascinated by how much science fiction has become science fact in Adam Bolts Human Nature. And its all due to CRISPR (pronounced crisper), a gene-altering technology that not only could facilitate designer babies, but possibly play a central role in putting the clamps on another acronym, COVID-19.

That timeliness is obviously on the side of Human Nature, a snazzy-looking documentary using sparkling graphics and top geneticists, journalists and one very adorable sickle-cell anemic to spell out a complicated subject in compelling, easy-to-grasp terms. But that same timeliness also works against it, given how now is not an advantageous moment for the films commercial aspects amid a landscape of shuttered theaters and a frightened populace whod like to avoid anything to do with medicine and science as sources of entertainment.

Yet, that double-edged sword fits snuggly in the wheelhouse of CRISPR (short for clustered regularly interspaced short palindromic repeats), a microorganism able to locate and repair defective DNA, as well as fend off invading viruses like COVID-19 by acting as a defense shield mimicking the offenders own DNA. But like the Internet, a revolutionary breakthrough for which CRISPR is often compared, theres a serious downside involving the morality of whether humans should have the right to, as the film calls it, play God. Namely, should parents be allowed to treat an embryo the same way theyd approach ordering a pizza? Well have the regular with blue eyes, blonde hair and an IQ of Einstein. Oh, and could you throw in some immense athletic ability, too?

Clearly, CRISPR has the potential to put us at the mercy of the type of mad scientists weve become accustomed to in just about every Bond film ever made. One geneticist, whose very name, Jennifer Doudna, includes DNA, admits having had a nightmare in which she comes face-to-face with Adolf Hitler! Are we willing to toy with the very real prospect of creating a master race?

Thats just one of the troubling questions Bolt confronts you with while weighing the pros and cons of a new frontier brimming in possibilities and danger. Personally, I come down on the side of CRISPRs benefits, particularly after meeting David Sanchez, a teen with sickle cell thats spent about half of his young life in hospitals receiving precious blood transfusions. Hes smart, personable and amazingly brave, so much so, you cant help but be all in when CRISPR offers him a chance at a more normal life. Yet, hes just as quick to recall to how hes learned to embrace -- even appreciate -- his illness because its made him a better, more resourceful kid, insights he would not have acquired had CRISPR been available when he was in utero. See? Hes torn, too.

Do we embrace a discovery wielding the promise of curing and preventing cancers and birth defects, or shun it for its ability to rob us of our unique individuality? Its a compelling argument I frankly wish Bolt had expanded more upon in his movies all-too-brief 90 minutes. But whats here is more than enough to spark a multitude of kitchen-table conversations about where we should set the limits on science, and more importantly, who should be making those decisions.

Given the disarray COVID-19 has put the world in, now probably isnt the time for us to evaluate, especially when CRISPR could well determine our fate by ridding our planet of a crippling plague. But what about after? Will, as Trump is fond to say, the cure be worse than the disease? Its a question for which Human Nature holds no answers, only utopian and despotic possibilities well be forced to uneasily choose between when and if the time comes.

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Movie review: Doc Human Nature strikes a nerve in the age of coronavirus - The Patriot Ledger

Alain Mrieux, founder of BioMrieux.

Latest update: April 1, 2020, at 4:47 pm ET.

Businesses around the world are shifting into overdrive to help battle the coronavirus, providing everything from rubber gloves and ventilators to diagnostic tools and, hopefully soon, vaccines. While the pandemic continues to wreak havoc, large corporations and small businesses are developing creative solutions to halt the spread of the virus.

Just as automakers famously shifted to make tanks and planes during World War II, todays global giants LVMH, Ford and GE to name a few are retooling their production lines to help make everything from hand sanitizers to respirators. On the medical front, there are more than three dozen COVID-19 vaccines under development, a smart move considering that two out of every three vaccines for infectious diseases fail, according to a study by the Massachusetts Institute of Technology.

Forbes will continue to update this list of private companies and how they are stepping up to fight the COVID-19 pandemic:

Testing:

Abbott Laboratories: Abbott Park, Illinois healthcare firm obtained emergency FDA authorization for its 5-minute coronavirus testing kit on March 27, with plans to start manufacturing 50,000 kits a day.

Alphabet: Through its healthcare arm Verily, Googles parent company launched a website where users can find nearby testing sites in four California counties.

Jeff Bezos.

Amazon: Jeff Bezos retail behemoth invested $20 million in the Amazon Web Services Diagnostic Initiative, which aims to speed up delivery of COVID-19 tests to the market.

BioMrieux: French biotech company, founded by billionaire Alain Mrieux,received emergency FDA approval for its subsidiarys new testing kit, which cuts testing times for the virus down to 45 minutes.

Carbon: California-based 3D printing unicorn backed by Russian tech investor Yuri Milner will soon be distributing testing swabs and face shields to hospitals in the Bay Area.

Cepheid: Sunnyvale, California molecular diagnostics company gained emergency FDA authorization for its new 45-minute COVID-19 testing kit.

Copan Diagnostics: Family-owned company located at the heart of Italys hard-hit Lombardy region makes diagnostic swabs for testing, airlifting 500,000 swabs to the U.S.

DiaSorin: Italian biotech company owned by billionaire Gustavo Denegri obtained emergency authorization from the FDA for its new 60-minute testing kit for COVID-19.

Mammoth Biosciences: South San Francisco-based biotech startup, founded by three 30 Under 30 alums, prototyped a rapid test by using the gene-editing tool Crispr to detect the disease.

Mesa Biotech: San Diego biotech business obtained FDA approval for its new 30-minute testing kit for COVID-19.

Puritan Medical Products: Maine-based diagnostic maker, one of the worlds largest makers of diagnostic swabs along with Italys Copan Diagnostics, is reportedly increasing production to make one million COVID-19 testing swabs a week.

Treatments:

AbbVie: North Chicago-based, publicly traded pharma firm is collaborating with authorities in the EU, the U.S. and China on experimental use of its HIV drug lopinavir/ritonavir to treat COVID-19.

AIM Immunotech: Florida-based pharmaceutical company announced on March 9 it would begin experimental testing of its chronic fatigue syndrome drug rintatolimod as a treatment for COVID-19 in Japan, at the National Institute of Infectious Diseases and the University of Tokyo.

Algernon Pharmaceuticals: Vancouver-based pharmaceutical firm is requesting FDA approval to begin trials of its chronic cough medication ifenprodil as a treatment for COVID-19.

AlloVir: Houston-based cell and gene therapy company is collaborating with Baylor College of Medicine to discover and develop T-cell therapies to fight COVID-19.

Apeiron Biologics: Vienna-based biotech firm started small-scale trials of its immunotherapy treatment on COVID-19 in China in February.

Ascletis: Hangzhou, China pharmaceutical company announced results of clinical trials of its antiviral drug danoprevir on COVID-19 patients in China; the small-scale study found that danoprevir combined with ritonavir is safe and well tolerated in all patients.

Bioxytran: Boston-based biotech outfit is developing a viral inhibitor to treat COVID-19.

Celltrion: South Korean healthcare firm is developing an antiviral treatment for COVID-19 as well as rapid self-testing kits that would provide results within fifteen to twenty minutes.

Cocrystal Pharma: Bothell, Washington pharma outfit is developing antivirals to treat COVID-19 using patents it recently acquired from the Kansas State University Research Foundation.

CytoDyn: Vancouver, Washington biotech firm announced preliminary results from three days of testing its antiviral drug leronlimab on COVID-19 patients in New York; the company stated in a press release that test results from the first four patients suggests immunological benefit within three days following treatment with leronlimab.

Eli Lilly: Indianapolis pharma company is partnering with Vancouver-based biotech outfit AbCellera to develop antibody-based treatments for COVID-19.

Emergent BioSolutions: Maryland drugmaker is developing treatments derived from the antibodies found in the blood of people who tested positive for the disease.

EUSA Pharma: British pharmaceutical firm initiated trials of its siltuximab antibody treatment on COVID-19 patients at the Papa Giovanni XXIII hospital in Bergamo, Italy; the company released initial data on April 1 showing that one third of patients experienced clinical improvement with reduced need for oxygen support and a further 43% saw their disease stabilise.

Fujifilm Toyama Chemical: Tokyo-based conglomerates flu drug favipiravir has shown promising results in early clinical trials on COVID-19 patients in China, and the company is investing $83 million in its biological manufacturing capabilities.

Gilead: The Californian biotech giant initiated clinical trials in March for its antiviral drug remdesivir on patients in the U.S.

Harbour BioMed: Cambridge, Massachusetts biomedical firm announced a collaboration with New Yorks Mount Sinai Health System to develop new human antibodies to treat COVID-19.

I-Mab Biopharma: Shanghai-based biopharma outfit announced it would begin clinical trials of its TJM2 antibody treatment on COVID-19 patients in the United States, with plans to expand to other countries affected by the pandemic.

ImmunoPrecise: Canadian life sciences company is teaming up with New York-based AI startup EVQLV Inc on researching antibody-based therapies and a vaccine for COVID-19.

Innovation Pharmaceuticals: Wakefield, Massachusetts biopharma firm is researching the use of its drug brilacidin part of a category of investigational new drugs called defensin mimetics, which could have antimicrobial effects as both a treatment and a vaccine for COVID-19, in separate efforts with a major U.S. university and with the Department of Health and Human Services.

ISR Immune System Regulation: Swedish immunotherapy firms subsidiary, ISR HBV, is conducting toxicological studies to determine whether its Immunolid ISR50 treatment could be used against COVID-19.

Kamada: Israeli pharmaceutical company is working on an antibody-based treatment for COVID-19 using the blood plasma of patients who recovered from the disease.

Mateon Therapeutics: Californian biopharma firm is testing a number of antiviral drugs as potential treatments for COVID-19 and is preparing to submit an application to the FDA in order to begin clinical trials on patients.

Merck KGaA: Darmstadt, Germany-based pharma multinational donated a supply of its multiple sclerosis drug interferon beta-1a to the French National Institute of Health and Medical Research in Paris for clinical trials on COVID-19 patients. The companys North American life sciences arm, MilliporeSigma, is supplying several vaccine efforts with reagents and other essential raw products for vaccine development.

Mesoblast: Australian medical firm is working with authorities in the U.S., Australia, China and Europe to evaluate the use of its remestemcel-L drug to treat COVID-19.

Mylan: Pennsylvania-based pharmaceutical firm restarted production of hydroxychloroquine, a drug used to fight lupus, malaria and arthritis, at its West Virginia factory; the drug is being tested as a treatment for COVID-19 in human trials in New York.

Pluristem Therapeutics: Haifa, Israel-based medical company is developing a cell-based therapy to treat COVID-19, announcing on March 30 it had dosed three Israeli patients under a compassionate use program, with plans to enroll more.

Leonard Schleifer.

Regeneron Pharmaceuticals: Westchester, New York biotech outfit, run by billionaires Leonard Schleifer and George Yancopoulos, is conducting clinical trials of its rheumatoid arthritis drug sarilumab, developed with French firm Sanofi, on patients in New York.

Roche: Swiss pharma titan, part-owned by billionaire Maja Oeri, is testing its arthritis drug tocilizumab to treat patients in China and received FDA approval to begin U.S. trials.

Roivant Sciences: Swiss pharma company is working with U.S. authorities to begin trials of its antibody treatment, gimsilumab, on COVID-19 patients.

Takeda: Japanese medical firm is working on hyperimmune therapy using blood plasma from previously infected patients.

Vir Biotechnology: The San Francisco-based firm is collaborating with Biogen and Chinese medical firm WuXi Biologics to manufacture antibodies that could treat the virus.

Vaccines:

AJ Vaccines: Danish vaccine developer is working on a COVID-19 vaccine that could hit the market in 2021.

Altimmune: The company is developing a novel intranasal vaccine for the coronavirus, making it one of three firms based in Gaithersburg, Maryland along with Emergent Biosolutions and Novavax thats working on treatments and vaccines for COVID-19.

Arcturus Therapeutics: San Diego-based vaccine maker is developing a COVID-19 vaccine with researchers at the Duke-National University of Singapore medical school in Singapore.

Biocad: Russian drug developer is researching a COVID-19 vaccine, with animal trials scheduled for late April.

Thomas and Andreas Struengmann.

BioNTech: German biotech firm backed by billionaire twins Thomas and Andreas Struengmann is working to develop a coronavirus vaccine in partnership with Pfizer and Fosun Pharma, chaired by billionaire Guo Guangchang.

CanSino Biologics: Tianjin, China-based pharma company isstarting clinical trials for its COVID-19 vaccine, using the vaccine technology deployed to develop the Ebola vaccine.

Codagenix: Melville, New York biotech firm is teaming up with the Serum Institute of India to develop a live-attenuated COVID-19 vaccine, which uses a live but weakened form of the virus.

Dietmar Hopp.

CureVac: German firm, funded by billionaire Dietmar Hopp and the Bill and Melinda Gates Foundation, received $87 million from the European Commission to scale up development of its coronavirus vaccine.

Dyadic: Jupiter, Florida company is collaborating with the Israel Institute for Biological Research on both treatment and a vaccine against COVID-19, using the firms gene expression platform.

Dynavax: Emeryville, California vaccine maker is working with the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Queensland to develop a COVID-19 vaccine.

EpiVax: Providence-based immunology firm is working with the University of Georgia and Miramar, Florida biotech outfit Generex on separate COVID-19 vaccine efforts.

ExpreS2ion: Danish biotech company received a grant of nearly $1 million from the European Union to develop a vaccine for COVID-19.

GeoVax: Atlanta-based medical company is collaborating with Wuhan-based BioVax to jointly produce a COVID-19 vaccine.

GlaxoSmithKline: British pharma titan is partnering with CEPI and Chengdu, China-based Clover Pharmaceuticals to use its pandemic vaccine adjuvant platform which boosts the immune response in patients receiving a shot to speed up development of COVID-19 vaccines.

Greffex: Houston-based genetic engineering firm is preparing to begin animal trials for its COVID-19 vaccine.

Heat Biologics: North Carolina biopharma company is developing a COVID-19 vaccine with the University of Miami.

iBio: Newark, Delaware biotech upstart is collaborating with Beijing-based CC-Pharming on the rapid development of a COVID-19 vaccine.

Inovio: Plymouth Meeting, Pennsylvania biotech business received $11.9 million in funding from the Department of Defense to rapidly produce a DNA vaccine for COVID-19 with drugmaker Ology Bioservices.

Johnson & Johnson: The companys pharma unit, Janssen, will start manufacturing its vaccine developed with the Department of Health and Human Services this month, with human trials set to begin by September and a public rollout hoped for early 2021. The company and the federal government are investing more than $1 billion in the vaccine effort.

Medicago: Quebec City-based biotech company received more than $7 million from the Canadian and Quebec governments to fund development of its COVID-19 vaccine.

Moderna: Massachusetts biotech company was the first tobegin human trials of its vaccine on March 16 in Seattle and could deploy it to health workers for emergency use by the fall.

Novavax: Maryland-based vaccine maker received $4 million in funding from CEPI to accelerate development of its vaccine candidates, with clinical trials expected in the late spring.

Sanofi: French medical firm is working with the federal government and Massachusetts-based Translate Bio to expedite its coronavirus vaccine, using technology previously used to develop one for SARS.

Sorrento Therapeutics: San Diego-based biotech firm is teaming up with Cambridge, MA gene therapy company SmartPharm Therapeutics to develop a gene-encoded COVID-19 vaccine; its also working with Chinese drugmaker Mabpharm on a fusion protein treatment for the disease.

Takis Biotech: Italian startup with just 25 employees is developing a vaccine with Stony Brook-based Applied DNA Sciences, with plans to begin human trials before the end of the year.

Themis Bioscience: Austrian biotech firm is part of a group, with the Institut Pasteur and the University of Pittsburgh, which received $4.9 million in initial funding from CEPI to build a COVID-19 vaccine modeled on the vaccine for measles.

Tonix Pharmaceuticals: New York-based pharma outfit is researching a potential COVID-19 vaccine based on the virus that causes horsepox.

Vaxart: San Francisco vaccine manufacturer Vaxart is working with Emergent Biosolutions to develop and manufacture an oral vaccine that can be taken as a tablet.

Vaxil: Israeli biotech startup began preclinical trials for its COVID-19 vaccine candidate.

Zydus Cadila: Indian pharma company announced it would fast-track development of a COVID-19 vaccine in February.

Protective Equipment And Sanitizer:

Anheuser-Busch InBev: The worlds largest beer company is making more than one million bottles of hand sanitizer from surplus alcohol at its breweries around the world.

Giorgio Armani.

Armani: Billionaire Giorgio Armanis luxury fashion brand converted all production at its Italian factories to manufacture single-use medical overalls on March 26.

Bacardi: The Bermuda-based spirits giant converted production at nine production facilities in Mexico, France, England, Italy, Scotland, Puerto Rico and the continental U.S. to make hand sanitizer.

BrewDog: Independent beermaker is making hand sanitizer at its distillery in Scotland.

Bulgari: The Italian luxury jeweler is manufacturing hand sanitizer with its fragrances partner, ICR, with plans to make hundreds of thousands of bottles by May.

Sandro Veronesi.

Calzedonia Group: Italian retail clothing group, owned by billionaire Sandro Veronesi, converted production at several plants in Italy and Croatia to manufacture masks and medical gowns, with initial production of 10,000 masks a day.

Cantabria Labs: Spanish health products and cosmetics firm converted production at one of its factories to make hand sanitizer.

Consomed: Tunisian mask and medical equipment maker put all of its workers, more than 70% of which are reportedly women, on quarantine inside the companys Kairouan factory to maximize production of protective gear.

Decathlon: Sporting goods empire founded by French billionaire Michel Leclercq partnered with Isinnova, a small engineering and design firm based in Italy, to convert snorkeling masks into respirators.

Diageo: The maker of Johnnie Walker whisky and Smirnoff vodka donated two million liters of ethyl alcohol, a byproduct of the distillation process, to hand sanitizer manufacturers.

Fanatics: Billionaire Michael Rubins online sportswear retailer converted its baseball jersey factory in Pennsylvania to make masks and gowns for medical workers.

Fiat Chrysler Automobiles: The multinational automaker announced on March 23 it would begin installing capacity to produce masks, which will be initially distributed in the U.S., Canada and Mexico.

Fippi: Italian diapers producer worked with the Lombardy region and the Polytechnic University of Milan to convert its factory to make up to 900,000 masks a day, which will go to frontline health workers facing a devastating outbreak in the region.

Go here to read the rest:
Coronavirus Business Tracker: How The Private Sector Is Fighting The COVID-19 Pandemic - Forbes

How prepared do you think we were for this moment of social distancing and for this global moment of hunkering down amidst uncertainty?In terms of social distancing, weve been social distancing; weve been virtualizing our lives since at least the advent of the telegraph in the 19th century. We have this idea of distance even now, where were communicating from away and communicating to others. But we also, as humans, have this deep need for physical connectivity. We are not virtual beings. And so, emotionally, were not ready for it. All of these structures for physical connectivity are gone, at least temporarily. Were almost in this Battlestar Galactica remake moment where were having to reconceptualize space and community. Its not that we will become un-physical beings, but were gonna have to figure out different ways of virtually sharing emotion and connectivity, at least until this danger passes.

Thats why organizations like PEN that are so focused on values are so critical, because these are the conversations that we have to have. Were going to have this incredible technology, but its up for grabs whether these technologies will be used to help or harm us.

You wrote at CNN.com about the human need for intimate physical connectivity. Can technology be a substitute for that? It seems like probably not.It cant be a substitute, but it can be a complement. And again, in our best possible world, I, for one, would love to live in some kind of hippie commune with real people there, and I also live, like many people, this global life where my friends and contacts are distributed around the world. I think we need to find that balance. But at times like this, our lives are becoming and feeling more virtual. And yes, theres a loss, and I think many of us are mourning that loss. But this is the world that we have now, and we have to make the most of it. Theres a lot of simple things that people can do. Make a list of all the people who you love and care about in your life, all the people who you think may be feeling isolated or alone, and just create a schedule of reaching out to them. My girlfriend and I are doing a virtual tea party with friends on Sunday where were gonna make tea, theyre gonna make tea, were gonna connect on FaceTime. We have to think of how we might do things differently. But its also not the case that when this crisis ends, society is just going to snap back to where it was, and were going to say, Wow, that was a crazy experience. Theres something happening now that is going to last beyond this.

What are some things that could be irrevocably different about our culture and the way we work and live, as a result of this moment?Were for sure not going fully back on virtualization. Were going to do things differently. Our sense of space is going to be different. A lot of people who are now working from home arent going to go back to physical offices because once companies figure out how they can work in this way, itll just be cheaper to have people stay at home. Were certainly going to change the way we think about global public health. If you asked a regular person, Wouldnt it make sense to have a super empowered World Health Organization with a global surveillance system that whenever any trip wire was hit, youd have an emergency response team that would fly to wherever that was and they would set up a command center and do what needed to be done? They would say, Yeah, dont we have that? And the answer is we dont. Because we have starved organizations like the WHO, because we have states that are demanding a level of control that doesnt make sense in our world of global challenges. One of the things that Im working on very, very actively now is imagining a third leg of the global political stool in addition to states and international institutions, and that is the democratic expression of the needs of our common humanity. It seems like its this big, crazy idea. But in these negotiations, no one is saying, Hey, climate change affects all of us; destroying our oceans affects all of us; global pandemics affect all of us. Who is standing up to help humanity? And thats what I think we need now.

I feel like Im at war from the battlestation of my office here on 81st Street in New York, so Im pretty focused on reading what I need to read now.

In Hacking Darwin, you wrote about genetics, you wrote about changing our genetic identity, perhaps to yield cures for diseases. Are you more or less optimistic about the potential for genetic science and cures than you were before?Im extremely optimistic. We are facing an enormous challenge today, but we now have almost godlike capacities to read, write, and hack the code of life. And those tools, Im firmly convinced, are going to save us, and were going to figure out treatments and were gonna have a vaccine not just for this, but for all kinds of challenges in the future. But these technologies dont come with a built-in value system. All technologies are value-neutral. Its up to us to determine what are the values that will guide the application of our most powerful technologies, and thats the issue. Thats why organizations like PEN that are so focused on values are so critical, because these are the conversations that we have to have. Were going to have this incredible technology, but its up for grabs whether these technologies will be used to help or harm us.

Finally, what are you reading, watching, or listening to right now?I would advise people at times of crisis like this to read poetry and literature. Im trying to do a little bit of that, but Im just all in and obsessed. Just last night I finished this incredible book, Spillover, by the amazing journalist David Quammen. And thats about zoonotic viruses like this, and our experiences in the past. Im now reading Betrayal of Trust by Laurie Garrett, which is about the destruction of our public health infrastructure. So when this is done, Im just going to beand I myself am a novelistback to reading the novels that I love so much. Maybe Ill read Proust and start thinking about Maman and her madeleine. But for now, I feel like Im at war from the battlestation of my office here on 81st Street in New York, so Im pretty focused on reading what I need to read now.

Wed like to know what books youre reading and how youre staying connected in the literary community. Click here to leave a voicemail for us. Your message could end up on a future episode of this podcast!

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The PEN Pod: Reimagining the Future with Jamie Metzl - PEN America

The quarter was brutal to say the least for most asset classes amid the coronavirus (COVID-19) pandemic. The S&P 500 Index was down about 20% for the quarter.

Amid the market mayhem, some health care stocks defied the downturn, thanks to announcements concerning development of drug/vaccine/diagnostic tests for new coronavirus.

Focusing on biotechs (leaving out diagnostics stocks), here the top five winners and losers for the quarter.

Benzinga is covering every angle of how the coronavirus affects the financial world.For daily updates,sign up for our coronavirus newsletter.

Genprex Inc (NASDAQ: GNPX): (+656.25%)

After ending 2019 in penny stock territory, shares of this gene therapy company began to gain ground after the company announced Fast Track Designation for its immunogene therapy in combination with AstraZeneca's(NYSE: AZN) Tagrisso for treating lung cancer. The momentum accelerated after it signed an exclusive agreement to license a diabetes gene therapy from the University of Pittsburgh.

After topping $7 in late February, the stock came off the highs amid the COVID-19 sell-off and managed to end the quarter with huge gains.

Vaxart Inc (NASDAQ: VXRT): (+405.71%)

Vaxart is a COVID-19 play and much of the quarter's gains were achieved on the back of the experimental oral vaccine candidate it's developing in partnership with Emergent Biosolutions Inc (NYSE: EBS).

Ibio Inc (NYSE: IBIO): (+324%)

Ibio, which develops human therapeutic proteins using advanced genetic engineering, joined the fray for a COVID-19 vaccine, which explains the surge in the stock.

Novavax, Inc. (NASDAQ: NVAX) (+241.2%)

Novavax was the beneficiary of dual catalysts: a COVID-19 vaccine in development and positive late-stage readout for its flu vaccine.

Trillium Therapeutics Inc (NASDAQ: TRIL): (+192.23%)

Thisimmuno-oncology company did not have much developments to justify its gain for the quarter.

Following a jump of about 63% in a single session in late February, the company issued a statement thatsaid "it is not aware of any material, undisclosed information related to the company that would account for the recent increase in the market price and level of trading volume of its common shares."

Related Link: Attention Biotech Investors: Mark Your Calendar For These April PDUFA Dates

Milestone Pharmaceuticals Inc (NASDAQ: MIST): (-88.51%)

This cardiovascular-diseases-focused biopharma was cruising along fine until COVID-19 sell-off started in March. The real punch came from an adverse clinical readout.

Novan Inc (NASDAQ: NOVN): (-84.97%)

Novan, which leverages on nitric oxide's naturally occurring anti-microbial and immunomodulatory mechanisms of action to treat various diseases, fell steeply at the start of the year. The trigger was a late-stage readout of its SB206 in molluscum contagiosum, which showed that the pipeline asset did not achieve statistically significant results for the primary endpoint.

The stock did not recover from this onslaught.

Acasti Pharma Inc (NASDAQ: ACST): (-84.49%)

Acasti also succumbed to a negative clinical readout for its lead prescription drug candidate CaPre, which did not achieve statistical significance for the primary endpoint of a late-stage study that evaluated it for treating elevated levels of triglycerides.

The company is now seeking FDA guidance for unblinding data from another Phase 3 study, and therefore expects a delay in reporting of topline results until the third quarter.

Salarius Pharmaceuticals Inc (NASDAQ: SLRX): (-81.98%)

This oncology-focused biotech gradually declined through the quarter, with some steep sell-off materializing amid its presentation at the BIO CEO & Investor conference in mid-February.

Amarin Corporation plc (NASDAQ: AMRN): (-81.34%)

Amarin shares, which ran up ahead and after the late-December FDA verdict on its application seeking label expansion for its fish oil pill, pulled back in January. The weakness intensified through the market meltdown. A negative court ruling sent the stock reeling this week.

2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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10 Biotech Winners And Losers In Q1 - Benzinga

In the field of prevention, the work of Mexican molecular medicine researcher Laura Palomares stands out. And today, her team is developing a vaccine against SARS-CoV-2, based on the work they have been doing in recent years against dengue and zika.

I am convinced that the only way that we are going to be able to respond to this type of pandemic in a timely manner is going to be using platforms. I am referring to a vaccine, for which we already have the entire production, development, stability train, etc. , said the chemical engineer from the Instituto Tecnolgico y de Estudios Superiores de Monterrey (ITESM), that holds a masters in Biotechnology, and a doctorate in science from UNAM.

Many times we think that the laboratory is going to discover a vaccine to cure the patient, and it is not like that. This type of vaccine requires a lot of time and a lot of effort in developing the processes for production and characterization, before reaching the final patient, Laura Palomares added.

With this idea in mind, the also researcher at the Institute of Biotechnology (IBt) of UNAM has promoted the development of one of these technological and methodological platforms focused on the aforementioned Zika and Dengue viruses, conditions particularly significant for Mexico due to their high numbers of contagion, every year in different parts of the country.

The result has been a vaccine created with recombinant DNA technology, which Palomares calls a chimera.

Lets put it in simple words, for people to understand: If we take away from the platform the zika and dengue viruses, and we put the coronavirus there, that way we can get a vaccine against SARS-Cov-2, says the member of the University Commission for Attention of the Coronavirus Emergency.

What took us two years in genetic engineering, adding on and taking off proteins, understanding how these capsids were going to be assembled, characterizing them, etc., all that we had already done. So now, we are replacing that with SARS-CoV-2, and that is precisely why we have advanced so much right now , Palomares continued.

The approach to the development of vaccines through platforms has also been the route taken by two vaccines against Covid-19 in the world that are currently under clinical evaluation: that of the North American company Moderna and that of the Chinese company CanSino Biologics, stated the expert.

The coronavirus vaccine is in the testing phase in animal models, a process in which the Zika and dengue vaccine has already been evaluated. If everything progresses positively, Palomares estimates that the first human tests could be carried out in three years.

In the case of the SARS-CoV-2 vaccine that she and her team are currently developing, they plan to collaborate wth the Mexican company Liomont, which has a manufacturing plant that would allow the production of this vaccine, this way Mexico does not have to depend on transnational companies.

So this pandemic is obviously terrible for us, because it is affecting the health of a large part of the population, but also a great opportunity to raise awareness, the researcher concluded.

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Mexico is already testing its own Covid-19 vaccine - The Yucatan Times

Pharma and biopharma companies dont want to work on their relationships. These companies want their relationships to work for them. Fair enough. Still, when it comes to relationships with contract manufacturing and drug development organizations (CDMOs), pharma and biopharma companies cant avoid intimacy. These relationships are rewarding to the extent pharma and biopharma companies are clear about their needs and the kinds of associations consistent with those needs.

Typically, the most pressing need is keeping costs down. But other needs are important, too. These include expertise with specialized technologies, challenging drugs, and complex formulations. Identifying needs will help pharma and biopharma companies decide whether their CDMOs should help with discrete activities or provide complete, end-to-end services. Pharma and biopharma companies may also want their CDMOs to help with business strategy and regulatory compliance.

Besides identifying potentially compatible CDMO partners, pharma and biopharma companies need to build CDMO relationships characterized by mutual trust. Here again, clear communication is essential. It can help both parties in a CDMO relationship resolve misunderstandings and overcome unanticipated challenges together. For a fuller discussion of the ways CDMO relationships can benefit from clear communication, see the rest of this article, which presents various pointers and perspectives from CDMO experts.

Thierry Cournez is head of end-to-end solutions at MilliporeSigma, which offers a comprehensive portfolio of high-quality products and services, including testing services, for biopharmaceutical development. According to Cournez, most emerging biotech companies that have very early data and need to take their molecule to commercialization dont have all the expertise in-house that they need to navigate the entire process. One major trend is complete services, as opposed to la carte offerings.

MilliporeSigmas Plug & Play Upstream Development Service eliminates the need to work with multiple vendors for upstream development, relieving bottlenecks and reducing time to clinic. The service covers cell line development from DNA transfection to cell banking. Process development activities, which run in parallel, start when the company receives material from the first clones.

Cournez says that two services that will continue to be important in pharmaceutical development are process development and analytical services. A robust process is critical for manufacturing success, he explains, and analytical services are the foundation that supports the entire life cycle of biologics.

A trend toward all-in-one CDMO services has also been observed by Richard Shook, director of drug product technical services and business integration at Cambrex. Any time a client has to go to multiple vendors, it creates a lot of seams and communication problems, he points out. A lot of dots are not connected. Critical items can be lost, especially internal knowledge. When a client works with a single vendor, he stresses, the partners create a knowledge base that can be carried forward with the project. Cambrex provides drug substance, drug product, and analytical services across the entire drug lifecycle.

Fujifilm Diosynth Biotechnologies (FDB) is a division of Fujifilm that focuses on biopharmaceutical contract manufacturing, especially drug substances for biologics. That includes cell culture and fermentation, development and manufacturing, and advanced therapies like gene therapy. Fujifilms director of strategic business development, Daniel DeVido, PhD, says there is growing interest in gene therapy products and gene modified cell therapies.

In the area of viral vectors, new products on the market such as Luxturna (from Spark Therapeutics) and Zolgensma (from Novartis) have moved that sector of the industry forward. Newly approved chimeric antigen receptor (CAR) T-cell therapies, such as Kymriah (from Novartis) and Yescarta (from Kite Pharma) are also injecting energy into the field. And monoclonal antibodies have been going strong for the last 10 to 15 years, with approximately 80 therapies approved and on the market.

The industry is well funded right now, DeVido points out. A lot of companies are pushing candidates forward.

That increased demand for cell culture services brings new technical challenges. Everybodys looking for increased titers, DeVido emphasizes. For gene therapy, yields and titers are much less than they are for cell culture, so everybodys looking for the next thing that will get gene therapy to produce on the scale that monoclonal antibodies are on now.

Lonza offers a range of CDMO services. Karen Fallen, the companys head of mammalian and microbial development and manufacturing, says that Lonza works with companies from several different segments, including small and virtual companies that have limited in-house resources and capabilities. A lot of them are really focusing on the science, she notes. Theyre looking for preclinical and clinical services.

In Lonzas view, some of the trends among the smaller companies are due to larger Series A financings. In past years, Series A deals would have been $10 or $15 million, but now they are running higher, up to $70 or $80 million. They have different ambitions now, Fallen points out. They want and are able to take the molecule further along the supply chain, even to launch. They want to stay with Lonza longer before they partner up with large pharma and/or out-license these molecules. She adds that Lonzas customers also have more complex molecules in their pipelines.

Lonzas other big segment consists of large pharma companies. They have assets, and they have experience, she says. What theyre looking for now is newer technologies, with newer modalitiesbioconjugation, highly potent small molecules, or cell and gene therapies, for example.

Almac Group provides an extensive range of contract development and manufacturing services across the drug development life cycle. The increased interest in pediatric formulations is driving a demand for mini-tablets, especially those in stick-pack dosage form. The rapidly expanding oncology space, by its nature, creates a need for CDMOs that have extensive capabilities in processing highly potent active pharmaceutical ingredients at the small-to-medium scale.

Were seeing an industry trend toward higher value, lower volume products, says Jonas Mortensen, vice president of business development at Almac. Our clients are asking us to take on commercial supply of their product, often at, or close to, the same scale we had previously provided for their clinical studies.

To meet these new needs, Almac has installed multiple stick-pack machines across its sites in the United Kingdom and the United States. Almac is also finalizing the qualification of a dedicated suite of eight processing rooms and equipment solely designed for, and dedicated to, processing of highly potent active pharmaceutical ingredients.

Mortensen anticipates that some near-term trends in CDMO services will include supply chain risk mitigation, end-to-end services, and GMP floor space. CDMOs, he points out, are increasingly being asked to demonstrate their ability to support multisite supply strategies through global facilities or act as a secondary site of manufacture.

Communication is a common theme when it comes to recommendations for working with a CDMO. MilliporeSigmas Cournez says that biotech companies should choose a CDMO that has the most experienced people in-house. Doing so can help biotech companies avoid having to deal with multiple vendors. He also recommends having a dedicated project manager who can provide transparent communication with the vendor and connect with subject matter experts in case of unexpected changes.

Good communication also contributes to transparency in a project. Project transparency is really important, insists Cambrex Shook. That can be limited due to the competitive landscape of the project.

If problems arise during project execution, ownership and communication is really important. If its not there, losses occur and there are timeline setbacks. This could impact the scope, and once you get off scope, [it takes] money and resources to get back on track.

An illustration of the importance of communication comes from Catalent, a company that offers a range of CDMO services, including its recently introduced GPEx Boost technology for cell line development. Michael Riley, vice president and general manager of biologics at Catalent, says that in a program the company is currently working on, a customer was on a highly accelerated path to a product filing for a fast-track product. Catalent was working with regulatory authorities to characterize the companys manufacturing process and move toward validation of that process. To do that, Riley explains, we had to have very robust conversations between multiple functions within our organization and their organization from a quality and development standpoint.

Trust can be a delicate issue in relations between a CDMO and a customer. To illustrate this point FDBs DeVido describes a face-to-face discussion that the company had with one of its customers. This discussion, which took place in FDBs office in Cambridge, MA, resolved some contractual disagreements. We were able to sit around the table and go through the legal issues, DeVido recalls. We cleared up a lot very quickly.

When you sit down face to face and have good discussions, he says, everyones a little more comfortable. Even though people may feel theyre not completely safeguarded from a one-in-a-million occurrence, they may feel comfortable the two parties are going to work together through whatever the issue is.

DeVido said that once youve selected a CDMO, its important to be transparent and trust the company. Youve done your due diligence, he proposes. Now trust your selection and the system theyre operating in.

Benefits of working with an experienced vendor can go beyond development and manufacturing. Cournez says that in one instance, an emerging biotech customer had the opportunity to engage in licensing discussions with a large pharmaceutical company. Because the emerging biotech was small, we hosted the large pharma company at one of our sites and ran the due diligence, which was a great success, he relates. This former emerging biotech now funds many different programs because of the success of their first molecule.

Some vendors warn that business strategies can backfire. Focusing too much on price and speed to market can be risky when researching or working with CDMO/CMO partners, according to Cournez. The service provider must simplify the process and reduce touchpoints throughout the process.

Mortensen says that due to the significant investment required in resource and training, many smaller biopharma companies often do not have a regulatory affairs department of their own. Therefore, its critical for sponsors to recognize the consultative benefit CDMOs bring to the table as an extension of their company to help fill in any regulatory knowledge gaps. This timely advice, integrated with early- and late-stage development, can enable a sponsor to adequately prepare, ensuring little or no delay when bringing its products to market.

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Making the Most of a CDMO Relationship - Genetic Engineering & Biotechnology News

Science writer, New Yorker contributor and author of the book Denialism Michael Specter joins Felix Salmon on the Slate Money podcast to break down the ongoing coronavirus crisis.

Specter explains how the virus spreads, potential food and medicine shortages it could cause and the possibility of developing immunity to infection. While the pandemic has shocked most of the world, Specter argues the only thing that should surprise anyone is the inept response of policy makers to the outbreak, particularly in the United States.

Specter also challenges some common misconceptions surrounding biotechnology, including the idea that GMOs are unnatural. Concerns about monoculture, the practice of growing a single crop like corn, on the other hand, are valid, Specter says. But that issue has nothing to do with genetic engineering. Its a problem that could be solved by a change in government policies: ending subsidies to corn and soybean growers. However, there are trade offs involved, and eliminating monoculture farms isnt the simple decision it seems.

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Podcast: Science writer Michael Specter on what you should know about the coronavirus, food security and GMOs - Genetic Literacy Project

NASHVILLE, Tenn., April 1, 2020 /PRNewswire/ --Concert Genetics, a technology company dedicated to advancing precision medicine, today announced the publication ofreal-world data on utilization and coding variability in medical claims for Next-Generation Sequencing (NGS)-based diagnostic tests. The study was done in collaboration with Merck, known as MSD outside the United States and Canada, and focuses on diagnostic testing among cancer patients in the U.S. It was accepted for presentation in the General Poster Session at the National Comprehensive Cancer Network's NCCN 2020 Annual Conference and is available online from JNCCNJournal of the National Comprehensive Cancer Network.

"The breathtaking speed of innovation in precision medicine is outpacing the healthcare system's ability to adapt," said Rob Metcalf, CEO of Concert Genetics. "As a result, the real-world data for observational research is often unavailable, too sparse, or insufficiently granular for evidence development. Concert's focus is delivering transparency and connectivity in genetic testing to enable precision medicine, and we were delighted to utilize our proprietary data and patented analytics to make this research possible."

The joint abstract is titled "Real-World Utilization and Coding Variability in Medical Claims for Next-Generation Sequencing (NGS)-Based Diagnostic Tests Among Cancer Patients in the U.S." It was scheduled to be presented at NCCN 2020, which was postponed due to COVID-19. The abstract is available at the following URL: https://jnccn.org/view/journals/jnccn/18/3.5/article-pHSR20-083.xml.

Concert's proprietary method for collecting and analyzing data in this space is described in U.S. Patent No. 10,223,501: "Tracking, Monitoring, and Standardizing Molecular and Diagnostic Testing Products and Services."

About Concert GeneticsConcert Genetics is a software and managed services company that advances precision medicine by providing thedigital infrastructure for reliable and efficient management of genetic testing. Concert's market-leading genetic test order management platform leverages a proprietary database of the U.S. clinical genetic testing market (today more than 140,000 testing products) and integrates with leading electronic health record and laboratory information management systems. Concert also provides genetic testing management solutions to leading health plans across the U.S. Learn more at http://www.ConcertGenetics.com.

CONTACT

Nick Tazik Concert Genetics (615) 861-2634 ntazik@concertgenetics.com

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Concert Genetics Presents Real-World Data on Utilization of NGS-Based Diagnostic Tests in NCCN 2020 Abstract - Yahoo Finance

A new study comparing genetics and the neural wiring of the brain suggests a diagnosis of attention-deficit/hyperactivity disorder (ADHD) results from a combination of factors. Investigators discovered that it takes many common genetic variations combining together in one individual to increase risk substantially.

At the same time, neuroimaging (MRI) experts have found differences in how the brains of people diagnosed with ADHD are functionally connected. However, its unclear how genetic risk might be directly related to altered brain circuitry in individuals diagnosed with ADHD.

In the new study, researchers focused their imaging analyses on selected brain regions, looking specifically at the communication between those regions and the rest of the brain in children with the diagnosis.

They discovered that one brain regions connectivity was linked to a higher risk of ADHD. However, a second, different part of the brain seemed to compensate for genetic effects and reduce the chances of an ADHD diagnosis.

The authors believe this research will lead to a better understanding of how genetic risk factors alter different parts of the brain to change behaviors and why some people at higher genetic risk do not exhibit ADHD symptoms.

The study appears in Biological Psychiatry: Cognitive Neuroscience and Neuroimaging.

We are now in a phase with enough data to answer some questions about the underlying genetics of a disorder that in the past have been difficult to elucidate, said senior author Damien Fair, Ph.D.

Previous imaging studies had shown different functional connectivity, and we assume those have a genetic basis.

ADHD is a neurodevelopmental psychiatric disorder that affects about 5 percent of children and adolescents and 2.5 percent of adults worldwide. The disorder is characterized by inattentive or hyperactive symptoms with many variations.

The paper focuses on 315 children between the ages of 8 and 12 who participated in a longitudinal ADHD study that began in 2008 at the Oregon Health & Science University in Portland. Fair, a neuroscientist and imaging researcher, and co-author Joel Nigg, Ph.D., a pediatric psychologist participated in the study. Robert Hermosillo, Ph.D., a postdoctoral researcher in Fairs lab, led the study.

The research team selected three areas of the brain based on a brain tissue database that showed where ADHD risk genes were likely to alter brain activity. To measure the brain communication to-and-from these regions on each side of the brain, the researchers used resting-state non-invasive magnetic resonance imaging (MRI) scans.

To begin to bridge genetic and neuroimaging studies of ADHD, researchers used MRI to scan the brains of children. Two regions previously associated with ADHD stood out. In one, a higher ADHD genetic risk correlated with a more active brain circuit anchored by the nucleus accumbens (orange arrow). Interestingly a weaker connection anchored by the caudate nucleus (blue arrow) seemed to protect children at high genetic risk from ADHD behaviors.

Next, they calculated a cumulative ADHD genetic risk score in the children, based on recent genome-wide studies, including a dozen higher-risk genetic regions reported two years ago by a large international collaboration called the Psychiatric Genetics Consortium.

In one brain region anchored by the nucleus accumbens, they found a direct correlation with genetics. Increased genetic risk means stronger communication between the visual areas and the reward centers, explained Hermosillo.

Another brain region anchored by the caudate yielded more puzzling results until the researchers tested its role as a mediator between genetics and behavior.

The less these two regions talk to each other, the higher the genetic risk for ADHD, said Hermosillo. It seems to provide a certain resiliency against the genetic effects of ADHD. Even among those with high risk for ADHD, if these two brain regions are communicating very little, a child is unlikely to end up with that diagnosis.

A third region, the amygdala, showed no correlation between connectivity to the other brain regions and the genetics.

According to the authors, the findings suggest that a genetic score alone will not be enough to predict ADHD risk in individuals because the results show both a genetic and neural contribution toward an ADHD diagnosis.

A future diagnostic tool will likely need to combine genetics and brain functional measures. The brain is not at the mercy of genes, added Hermosillo. Its a dynamic system not preprogrammed for disorders. It has the capacity to change.

Source: Elsevier

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Study Probes Interaction of Genetics and Neural Wiring in ADHD - PsychCentral.com

Yann Joly, Research Director of the Centre of Genomics and Policy

Research Director of the Centre of Genomics and Policy and Associate Professor at the Department of Human Genetics, Yann Joly is a Lawyer Emeritus from the Quebec Bar and a Fellow of the Canadian Academy of Health Sciences. He is currently a member of the Quebec task force on theCOVID-19 Biobank.

Last week, Joly and his collaborators from 16 countries announced the establishment of the international Genetic Discrimination Observatory (GDO). A world first, the GDO is an online platform committed to preventing the misuse of a patients genetic information. This is particularly important within the current context of the COVID-19 pandemic when researchers are collecting samples and data from patients in order to better understand this new disease and develop effective vaccines or therapeutics.

In this Q&A, Joly gives readers more information on genetic discrimination and what is being done to combat it.

Genetic discrimination (GD) means treating people differently from the rest of the population or unfairly profiling them based on actual or presumed genomic and other predictive medical data. The genetic information contained in an individuals DNA can uniquely identify or provide some information about a person, including future probabilities that this individual will develop diseases. Other predictive health information, such as biomarkers, can also be used to discriminate and should also be considered under the GD heading.

This information can be of interest to third parties like insurers, employers, or government officials. Like sexual, ethnic or disability-based discrimination, genetic discrimination is a source of exclusion and can limit the social and professional opportunities of a person thus becoming a source of psychological distress.

There are documented cases of GD reported in studies carried out in a limited number of countries based on predictive test results and family history for a handful of severe single-gene conditions in the context of life insurance or employment. The available evidence is fragmentary, and the methodology used in many studies is inconsistent.

The Genetic Non-Discrimination Act (hereinafter S-201) was passed in April 2017 and is currently applicable in Canada. While it does not solve all the challenges posed by genetic discrimination, it is an important first step. The Act generally makes it a criminal offense to require a person to undergo a genetic test or to report the results as a condition precedent to the provision of goods and services. However, the Quebec Court of Appeal recently declared that the core elements of S-201 were not constitutionally valid.

This decision was appealed to the Supreme Court of Canada and we are currently waiting for their decision on the matter. In the meantime, S-201 continue to be applied. If the Supreme Court is of a similar opinion to that of the Court of Appeal, it could be invalidated.

In addition to the protection provided by S-201, Canadian privacy laws would fully apply to genetic data, which is considered personal information.

Genetic information is increasingly shared across national borders or transcending them, thus limiting the effectiveness of protections built solely around national approaches. Strictly legal solutions, because they tend to be static, are also challenged to keep pace with rapidly evolving science such as genetics.

At its core discrimination is a social phenomenon that needs to be addressed collaboratively and internationally by all stakeholders. The GDO will provide the platform to undertake this important work, which will include documenting instances of genetic discrimination, identifying most effective preventing measures and conveying information, tools and good practices to all stakeholders including the public.

COVID-19 presents Quebecers with an unprecedented health threat that requires us to stand together as a society and take action to protect one another and help find medical solutions to the disease. The COVID-19 Biobank provides us a unique opportunity to learn more about the biological foundations of the disease, individuals at risk and preventive solutions.

The risk of discrimination associated with providing a biological sample and medical information to the Biobank is very small. The data provided is research information that is not clinically validated and should be of no interest to most third parties. Moreover, the collected information is coded, and protected by confidentiality laws and robust security measures. Furthermore, data access will be subject to ethics approval and in some cases controlled access measures.

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Yann Joly on the fight against genetic discrimination - McGill Reporter

MELBOURNE, Australia, April 01, 2020 (GLOBE NEWSWIRE) -- Molecular diagnostics company Genetic Technologies Limited(ASX: GTG; NASDAQ: GENE, Company), provides the following update to the market.

Colorectal test sales commence

As announced to the market on 31 January 2020, the Company has fully commissioned its Australian Laboratory for the provisioning of its generation 3 breast cancer test (GeneType for Breast Cancer), with sales having commenced during the quarter. We are pleased to report that this is now accompanied by the first-to-market GeneType for Colorectal Cancer test with sales also having now commenced.

Medical practitioner support

Both tests have been well received by medical practitioners, with over 15 clinics in Australia having agreed to offer the GeneType portfolio of tests. Overall, in excess of 100 test kits having been requested and approximately half of those samples have been received into the Melbourne laboratory during the first 4 weeks on market.

High risk breast cancer patients detected

An interim analysis of those patients who received the GeneType for Breast Cancer test in Australia has revealed that 4 patients have already been identified as potentially being at high risk of developing breast cancer. It is highly significant that these patients were not eligible for hereditary mutation testing and would not have been identified as high risk during routine health checks.

Clinical utility and reimbursement initiatives Genetic Technologies continues to progress its in-house R&D program in support of the tests. Data derived from large scale cohort studies, have confirmed that both the discrimination and calibration of both GeneType tests are excellent and set the stage for progressing our plans to develop clinical utility evidence in support of our reimbursement strategy.

Clinical utility studies have been designed to support both the breast and colorectal cancer tests and the Company is currently engaging with potential clinical collaborators to complete these studies at the earliest opportunity. As alluded to above, the evidence is building that the GeneType tests have the potential to personalize individual screening recommendations.

Tele-health and Consumer Initiated testing to relieve practitioner stress and opens access to Mass consumer markets

Notwithstanding the above, the Company is taking an aggressive and pro-active response to the current COVID-19 pandemic. In light of world-wide recommendations on social distancing, which is impacting on our ability to fully engage with physicians, we have brought forward our plans to introduce a Consumer Initiated Testing (CIT) Platform. The Company is in the final stages of choosing an independent provider network who will oversee patient ordering of the consumer-initiated testing (CIT) pipeline. This sales pipeline deviates from a traditional sales approach that targets clinicians and instead allows patients to request a test directly, with clinician oversight of the testing process through an independent provider network and telemedicine. When a consumer is interested in purchasing a GeneType product, a clinician from this independent network will review the patient health history before confirming whether or not the patient may proceed with testing. The independent clinician will then order the test for the patient and will also review the final test results prior to delivering them back to the patient

In an age where primary care clinicians are overburdened by large patient volume and thus restricted to short clinical visits, certain disease risk assessments are often overlooked, particularly if the patient is asymptomatic, or visually healthy.

The current push to adopt telemedicine as recently announced by Australias minister for Health Minister Greg Hunt is exactly on point with GTGs CIT platform strategy and has been in development by GTG over the past 3 months.

Personalized proactive approach to health

Understanding a patients risk of developing disease can lead to earlier screening, more frequent and alternative surveillance methods, options for risk-reducing medications, and at the very least, some suggested lifestyle changes. However, in order to be proactive about screening and prevention measures, patients and physicians alike, must understand the patients risk of developing disease. By allowing our GeneType risk assessment product lines to be requested via CIT, we are enabling a patient to take a proactive approach to his/her healthcare.

Dr George Muchnicki Acting CEO and Justyn Stedwell Company SecretaryOn behalf of the Board of DirectorsGenetic Technologies Limited+61 3 9412 7000

About Genetic Technologies Limited

Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE) is a diversified molecular diagnostics company. GTG offers cancer predictive testing and assessment tools to help physicians proactively manage patient health. The Companys lead products GeneType for Breast Cancer for non-hereditary breast cancer and GeneType for Colorectal Cancer are clinically validated risk assessment tests and are first in class.

Genetic Technologies is developing a pipeline of risk assessment products.

For more information, please visit http://www.gtglabs.com.

Investor Relations and Media (US)Dave Gentry, CEORedChip CompaniesOffice: 1 800 RED CHIP (733 2447)Cell: US 407 491 4498dave@redchip.com

Caution Regarding Forward-Looking Statements

This press release contains forward-looking statements Words such as may, should, could, would, predicts, potential, continue, expects, anticipates, future, intends, plans, believes, estimates, and similar expressions, as well as statements in future tense, often signify forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Forward-looking statements are based on information that the Company has when those statements are made or managements good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

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Genetic Technologies Limited Announces Market Update on Sales, Early Test Results and Launch of Consumer Initiated Testing - BioSpace

Aaron Grech April 1st, 2020 - 8:11 PM

The godfather of heavy metal Ozzy Osbourne is making mind blowing health progress according to his daughter Kelly Osbourne, who recently spoke to Entertainment Tonight. The performer was receiving stem cell treatment recently, to help support his battle against complications caused by Parkinsons disease.

Seeing after one treatment of stem cell what has happened and the progress that hes made is mind-blowing, Kelly Osbourne stated. He wants to get up. He wants to do things. He wants to be part of the world again. Hes walking better. Hes talking better. His symptoms are lessening. He is building the muscle strength back that he needs after his spine surgery.

Osbourne revealed that he had Parkinsons disease at the beginning of this year during an interview withGood Morning AmericasRobin Roberts. Kelly Osbourne also explained that the her father has been feeling better as a result of his treatment, although he is still forced to stay inside due to the fears associated with the spread of COVID-19.

Everything is starting to fall into place now and it has given us so much hope, she explained. We are very grateful to the doctors that are helping him. Hes ready to get out of the house and now he cant get out of the house. He keeps saying to me, Ive been on quarantine for almost two years, and now Im feeling better and the world is on quarantine.

Osbourne has faced a slew of health complications in recent years, froma bout ofpneumonia, to a stage injury which requiredintense surgery.He has had to cancel multiple tours during the past couple of years due to his health concerns although he was in the studio last year to record his latest studio album release Ordinary Man.

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Ozzy Osbournes Daughter Kelly Reports the Singer Is Making Mind Blowing Progress After Stem Cell Treatment - mxdwn.com