StemCell Therapy

A New Business Research Report released by DBMR with title Global Pharma Clinical Trial Digitization Market Study Forecast till 2027. This Report presents detailed competitive analysis including the market share, size, growth, trends, demand, revenue, cost structure, segment and future scope 2027. This study categorizes the global Health and Safety Products breakdown data by manufacturers, region, type and applications, also analyzes the market drivers, opportunities and challenges. This Global Pharma Clinical Trial Digitization market report brings data for the estimated year 2021 and forecasted till 2027 in terms of both, value (US$ MN) and volume (MT). The report also consists of forecast factors, macroeconomic factors, and a market outlook of the Pharma Clinical Trial Digitization market. The study is conducted by applying both top-down and bottom-up approaches and further iterative methods used to validate and size market estimation and trends of the Global Pharma Clinical Trial Digitization market. Pharma Clinical Trial Digitization Market Report will add the analysis of the impact of COVID-19 on this industry.

Get Exclusive Sample (350 Pages PDF) Report: To Know the Impact of COVID-19 on this Industry@ https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-pharma-clinical-trial-digitization-market&aB

This upgradation of healthcare IT infrastructure and technological assistance being provided on vast scale is driving the market growth at the rate of 5.70% annual for the mentioned seven years. This momentum will be maintained by rising practice of individualized drug printing.

Data Bridge Market Research analyses the market to grow at a CAGR of 5.7% in the above-mentioned forecast period. Growing demand for personalized medicine is expected to create new opportunity for the pharma clinical trial digitization mark

Pharma Clinical Trial Digitization Market Overview:

Clinical trial digitization allows the processing in different forms of voluminous patient-related data. Such data are being used by pharmaceutical companies to improve the effectiveness of trial execution.

Growing demand for quality data is expected to drive the market growth. Some of the other factors such as increasing demand for personalized drugs, increasing adoption of new technology in clinical research, growing research & development promoting outsourcing and increasing diseases prevalence will drive the market in the forecast period of 2020 to 2027

Global Pharma Clinical Trial Digitization Market 2020 Reportencompasses an infinite knowledge and information on what the markets definition, classifications, applications, and engagements are and also explains the drivers and restraints of the market which is obtained from SWOT analysis. By applying market intelligence for this Pharma Clinical Trial Digitization Market report, industry expert measure strategic options, summarize successful action plans and support companies with critical bottom-line decisions. Additionally, the data, facts and figures collected to generate this market report are obtained forms the trustworthy sources such as websites, journals, mergers, newspapers and other authentic sources. Development policies and plans are discussed as well as manufacturing processes and cost structures are also analyzed. This report also states import/export consumption, supply and demand Figures, price, cost, revenue and gross margins.

According to this report Global Pharma Clinical Trial Digitization Market will rise from Covid-19 crisis at moderate growth rate during 2020 to 2027. Pharma Clinical Trial Digitization Market includes comprehensive information derived from depth study on Pharma Clinical Trial Digitization Industry historical and forecast market data. Global Pharma Clinical Trial Digitization Market Size To Expand moderately as the new developments in Pharma Clinical Trial Digitization and Impact of COVID19 over the forecast period 2020 to 2027.

TO UNDERSTAND HOW COVID-19 IMPACT IS COVERED IN THIS REPORT, GET FREE COVID-19 SAMPLE @https://www.databridgemarketresearch.com/covid-19-impact/global-pharma-clinical-trial-digitization-market?ab

Pharma Clinical Trial Digitization Market report provides depth analysis of the market impact and new opportunities created by the COVID19/CORONA Virus pandemic. Report covers Pharma Clinical Trial Digitization Market report is helpful for strategists, marketers and senior management, And Key Players in Pharma Clinical Trial Digitization Industry.

Pharma Clinical Trial Digitization Market Segments Outlook:

By Services (Drug Dose Adjustment, Drug Impact Monitoring, Medical Prescription System, Bioprinting, Preventive Therapy, Individualized Drug Printing)

By Application (Clinical Data Management, Trial Monitoring, Patient Recruitment and Enrollment)

By Themes (Digital Continuity Across Clinical Trial IT Systems, Patient-centric Remote and Virtual Trial Design, Direct-to-patient Home Services)

List of Companies Profiled in the Pharma Clinical Trial Digitization Market Report are:

Antidote Technologies, Inc.AparitoClinerion Ltd.CliniOps, Inc.ConsilxDeep 6 AIKoneksa Health Inc.Medidata SolutionsOraclePatientsLikeMeTrialbeeTriNetX, Inc.Veeva SystemsComplete Report is Available (Including Full TOC, List of Tables & Figures, Graphs, and Chart) @https://www.databridgemarketresearch.com/toc/?dbmr=global-pharma-clinical-trial-digitization-market&Ab

Pharma Clinical Trial Digitization Reportdisplays data on key players, majorcollaborations, merger & acquisitions along with trending innovation and business policies. The report highlights current and future market trends and carries out analysis of the effect of buyers, substitutes, new entrants, competitors, and suppliers on the market. The key topics that have been explained in this Pharma Clinical Trial Digitization market report include market definition, market segmentation, key developments, competitive analysis and research methodology. To accomplish maximum return on investment (ROI), its very essential to be acquainted with market parameters such as brand awareness, market landscape, possible future issues, industry trends and customer behavior where this Pharma Clinical Trial Digitization report comes into play.

Global Pharma Clinical Trial Digitization Market Scope and Market Size

On the basis of services, the pharma clinical trial digitization market is segmented into drug dose adjustment, drug impact monitoring, medical prescription system, bioprinting, preventive therapy, and individualized drug printing.

Based on application, the market is segmented into clinical data management, trial monitoring, patient recruitment and enrollment.

The pharma clinical trial digitization market on the basis of theme is segmented into digital continuity across clinical trial it systems, patient-centric remote and virtual trial design and direct-to-patient home services.

Market Size Segmentation by Region & Countries (Customizable):

North America (Canada, United States & Mexico)Europe (Germany, the United Kingdom, Benelux, France, Russia & Italy)Asia-Pacific (Japan, South Korea, China, India & Southeast Asia)South America (Argentina, Brazil, Peru, Colombia, Etc.)Middle East & Africa (United Arab Emirates, Egypt, Saudi Arabia, Nigeria & South Africa)Key Questions Answered

What impact does COVID-19 have made on Global Pharma Clinical Trial Digitization Market Growth & Sizing?

Who are the Leading key players and what are their Key Business plans in the Global Pharma Clinical Trial Digitization market?

What are the key concerns of the five forces analysis of the Global Pharma Clinical Trial Digitization market?

What are different prospects and threats faced by the dealers in the Global Pharma Clinical Trial Digitization market?

What are the strengths and weaknesses of the key vendors?

Major Key Contents Covered in Pharma Clinical Trial Digitization Market:

Introduction of Pharma Clinical Trial Digitization with development and status.

Manufacturing Technology of Pharma Clinical Trial Digitization with analysis and trends.

Analysis of Global Pharma Clinical Trial Digitization market Key Manufacturers with Company Profile, Product Information, Production Information, and Contact Information.

Analysis of Global Pharma Clinical Trial Digitization market Capacity, Production, Production Value, Cost and Profit

Analysis Pharma Clinical Trial Digitization Market with Comparison, Supply, Consumption, and Import and Export.

Pharma Clinical Trial Digitization market Analysis with Market Status and Market Competition by Companies and Countries.

2020-2027 Market Forecast of Global Pharma Clinical Trial Digitization Market with Cost, Profit, Market Shares, Supply, Demands, Import and Export

Trending factors influencing the market shares of APAC, Europe, North America, and ROW?

Pharma Clinical Trial Digitization Market Analysis of Industry Chain Structure, Upstream Raw Materials, Downstream Industry

Strategic Points Covered in Table of Content of Global Pharma Clinical Trial Digitization Market:

Chapter 1: Introduction, market driving force product Objective of Study and Research Scope the Pharma Clinical Trial Digitization market

Chapter 2: Exclusive Summary the basic information of the Pharma Clinical Trial Digitization Market.

Chapter 3: Displaying the Market Dynamics- Drivers, Trends and Challenges of the Pharma Clinical Trial Digitization

Chapter 4: Presenting the Pharma Clinical Trial Digitization Market Factor Analysis Porters Five Forces, Supply/Value Chain, PESTEL analysis, Market Entropy, Patent/Trademark Analysis.

Chapter 5: Displaying market size by Type, End User and Region 2010-2019

Chapter 6: Evaluating the leading manufacturers of the Pharma Clinical Trial Digitization market which consists of its Competitive Landscape, Peer Group Analysis, BCG Matrix & Company Profile

Chapter 7: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries (2020-2027).

Chapter 8 & 9: Displaying the Appendix, Methodology and Data Source

Finally, Pharma Clinical Trial Digitization Market is a valuable source of guidance for individuals and companies in decision framework.

Thanks for reading this article; you can also get individual chapter wise section or region wise report version like North America, Europe or Asia.

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Data Bridge Market Research

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Pharma Clinical Trial Digitization Industry 2021 With Covid-19 Impact on Market Research by Size, Top Leading Countries, Companies, Consumption,...

Personalized Medicine at FDA: The Scope & Significance of Progress in 2020describes how newly approved tests and therapies will help transform care for molecularly selected subsets of patients with cancer, rare diseases, and common/infectious diseases. Seven of the personalized therapies listed in the report are designed to address the root causes of devastating rare genetic diseases for which patients had few treatment options before. The report also notes how expanded indications will extend the unprecedented benefits of cancer immunotherapies to patients with solid tumors of all types that are tumor mutational burden-high (TMB-H). Perhaps most significantly, it explains how the first FDA-approved blood-based biomarker tests for cancer will help guide targeted treatment strategies for patients who are unable to undergo invasive operations to obtain tissue biopsies. The emergence of blood-based biomarker testing anticipates a new era in which cancers are detected at earlier stages, when they are easier and less expensive to treat.

"Personalized Medicine at FDA: The Scope & Significance of Progress in 2020 documents FDA's unwavering commitment to expanding the frontiers of personalized medicine while also demonstrating industry's commitment to developing innovative and groundbreaking products that serve patients and make health systems more efficient," said PMC President Edward Abrahams.

About the Personalized Medicine Coalition:The Personalized Medicine Coalition, a 501(c)3 organization comprised of 14 distinct stakeholder groups within health care, promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system. For more information, please visit http://www.personalizedmedicinecoalition.org.

Contact: Christopher J. WellsPersonalized Medicine Coalition[emailprotected]202-580-9780

SOURCE Personalized Medicine Coalition

http://www.personalizedmedicinecoalition.org

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Personalized Medicines Top One-Third of All New Drug Approvals in 2020 for Third Time in Last Four Years - PRNewswire

February 11, 2021 -A team from Cleveland Clinic has developed a precision medicine platform designed to accelerate cancer gene therapies and genome-informed drug discovery.

In a study published in Nature Genetics, researchers describe the My Personal Mutanome (MPM) platform. The platform features an interactive database that offers insight into the role of somatic mutations in cancer acquired mutations that cant be passed to offspring and prioritizes mutations that may be responsive to drug therapy.

Although advances in sequencing technology have bestowed a wealth of cancer genomic data, the capabilities to bridge the translational gap between large-scale genomic studies and clinical decision making were lacking, said Feixiong Cheng, PhD, assistant staff in theGenomic Medicine Institute, and the studys lead author.

MPM is a powerful tool that will aid in the identification of novel functional mutations/genes, drug targets and biomarkers for cancer, thus accelerating the progress towards cancer precision medicine.

The team used clinical data to integrate nearly 500,000 mutations from over 10,800 tumor exomes the protein-coding part of the genome across 33 cancer types into the platform. The team then systematically mapped the mutations to over 94,500 protein-protein interactions (PPIs) and over 311,000 functional protein sites where proteins physically bind with one another. Researchers then incorporated patient survival and drug response data.

The platform analyzes the relationships between genetic mutations, proteins, PPIs, protein functional sites, and drugs to help users easily search for clinically actionable mutations. The MPM database includes three interactive visualization tools that offer two- and three-dimensional views of somatic mutations and their associated survival and drug responses.

According to the researchers, previous studies have linked disease pathogenesis and progression to mutations and variations that disturb the human interactome, the complex network of proteins and PPIs that impact cellular function. Mutations can disrupt the network by directly changing the normal function of a protein, known as nodetic effect, or by altering PPIs, known as edgetic effect.

Additionally, in a separate, previous study, a team of researchers found that somatic mutations were highly enriched where PPIs occurred. The group also demonstrated that PPI-perturbing mutations were significantly correlated with drug sensitivity or resistance as well as poor survival rate in cancer patients.

The results from another study published inNature Genetics, which was a collaboration between Cleveland Clinic and several other institutions, motivated us to develop the mutanome platform, said Cheng.

OurNature Geneticsfindings, along with previous research, provide proof-of-concept of both nodetic and edgetic effects of somatic mutations in cancer. What we learned from that study inspired us to develop a systems biology tool that, by mapping mutations to PPI interfaces and protein functional sites and integrating survival and drug response data, identifies cancer-driving and actionable mutations to guide personalized treatment and drug discovery.

Researchers expect that MPM will lead to a better understanding of mutations at the human interactome network level. This could lead to new insights in cancer genomics and treatments, ultimately achieving the goal of cancer precision medicine.

The team will continue to update MPM annually in order to provide researchers and physicians with the most comprehensive, complete data available. Researchers also plan to apply advanced analytics technologies to their insights to improve treatment development for other conditions.

OurNature Geneticsstudy also demonstrates the nodetic and edgetic effects of mutations/variations in other diseases, said Cheng.

As a next step, we are developing new artificial intelligence algorithms to translate these genomic medicine findings into human genome-informed drug target identification and precision medicine drug discovery (i.e., protein-protein inhibitors) for other complex diseases, including heart disease and Alzheimers disease.

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Precision Medicine Platform Aims to Advance Cancer Gene Therapies - HealthITAnalytics.com

IRVINE, Calif.--(BUSINESS WIRE)--GATC Health, an innovative technology company focused on whole genome testing and Predictive Multiomics, today announced the completion of its Viral Immunity Platform (VIP), a prediction tool for personal immune response analysis. VIP can predict the likelihood of infection and severity of outcomes for SARS-CoV-2 and other viral infections.

VIP runs on the companys Multiomic Advanced Technology (MAT), which combines machine learning, neural networks, deep sequencing and bioinformatics in a comprehensive platform. MAT integrates personal metadata to accurately predict individual immunity response to agents compromising the immune system. MAT also combines advanced AI systems and quantitative genomics, proteomics and microbiomics to decipher billions of datapoints, delivering extremely accurate results.

VIP provides personalized medical analysis that assesses risk of infection, predicts immune response, identifies potential complications, and could even provide therapeutic guidance. The results enable patients and physicians to make informed decisions about individual immunity and safety, including who can return to work, who should attend social gatherings, who may have a moderate illness, and who is at high risk for a serious infection or prone to complications.

In our current climate, its more important than ever to have accurate information about how we will react to COVID or other viral infections so that we can make well-educated decisions, said John Stroh, Interim CEO of GATC Health. Our new VIP technology platform has the ability to provide predictive, actionable information about how an individual will respond when exposed to a virus. Armed with this knowledge, physicians and patients can make decisions to reduce their risk of infection, determine the most likely course of an infection if it does occur, and plan the appropriate treatment.

GATC Healths Viral Immunity Platform will provide customers with a personalized report outlining predicted viral infection risk, immunity response, and potential complications. VIP is expected to be available for consumers and physicians in Q2 2021.

About GATC Health

GATC Health is a pioneering technology company using Predictive Multiomics to advance drug discovery and improve human health. GATC Healths proprietary Multiomic Advanced Technology (MAT) sequences an individuals DNA, reading the entire genome and analyzing the full data set of omics, including genomics, proteomics, and microbiomics. A complete understanding of a persons genetics combined with the evaluation of other omics yields the most comprehensive individual health analysis available, which can lead to fast-tracking drug development, pre-screening clinical trial participants, identifying new drugs and repurposing existing treatments. GATC Healths innovative technology can help take healthcare from reactive to predictiveit is truly personalized medicine. For more information about GATC Health, visit http://www.GATCHealth.com.

Disclaimer

The information set forth herein is presented for informational purposes only and should not be deemed an offer to sell securities. This presentation contains information which the Company believes to be correct, including certain financial information and projections, but the Company does not guarantee as to the accuracy or completeness of such information. The Company reserves the right to modify or amend the information contained herein.

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GATC Health Introduces Personalized Immunity Platform to Predict Individual Response to SARS-CoV-2 and Other Viral Infections - Business Wire

SALT LAKE CITY, Feb. 12, 2021 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc.. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, announced today additional data further validating the prognostic power of its Prolaris test and its ability to help accurately predict which men with more aggressive prostate cancer will benefit from intensification of therapy and which patients may safely avoid such treatments. This second validation study was presented during an oral presentation at the American Society of Clinical Oncology Genitourinary Cancer Symposium (ASCO-GU) by Jonathan Tward M.D., Ph.D, associate professor in the Department of Radiation Oncology at the University of Utah.

According to estimates by the American Cancer Society, 248,530 new cases of prostate cancer are expected to be diagnosed this year in the U.S. While early screening tests have helped reduce the mortality rate, they can often result in overdiagnosis and overtreatment of a disease that is clinically insignificant. The Prolaris test can more accurately predict the aggressiveness of the cancer allowing for more precise treatment and avoidance of more intense therapies with a patients parallel morbidities.

There are many viable treatment paths for men with prostate cancer, said Dr. Tward. This new data helps distinguish the most appropriate personalized treatment path for each patient based on how their specific tumor is behaving. For some men, this means being able to avoid overtreating patients with therapies including hormone treatment that can momentously impact their quality of life, while still appropriately treating their prostate cancer.

The new data comes from a second study following previous data, recently published in Clinical Genitourinary Cancer in January 2021, that incorporated men treated surgically or with radiation therapy. This new study combined a Prolaris molecular risk score threshold with a clinical model for predicting a patients benefit from androgen deprivation therapy. Prolaris determined that about one of every two men with unfavorable intermediate-risk and one of every five men with high-risk prostate cancer are below the proposed threshold associated with aggressive disease and can therefore safely be treated with less intense therapy while maintaining the benefits of treatment. Additional key findings revealed that the Prolaris test was an accurate predictor of progression to metastatic disease.

Myriad Genetics was the first company to offer a test that directly measures the molecular biology of an individual patients prostate cancer, said Todd D. Cohen, M.D., vice president of Medical Affairs for Urology at Myriad Genetics. This study by Dr. Tward and his team is another strong validation of the prognostic power of the Prolaris test and our ongoing commitment to providing healthcare professionals with the tools needed to determine the most effective treatments and monitoring strategies for each patient.

In March 2020, the National Comprehensive Cancer Network updated its professional guidelines to include biomarker testing for unfavorable intermediate and high-risk patients with prostate cancer. With the updated guidelines, Prolaris was one of only two prognostic tests to be considered for those expanded indications. Approximately 60% of men with prostate cancer currently have insurance or Medicare access to Prolaris, and Myriad continues to work toward expanding access so that every man who is facing difficult treatment decisions will be able to utilize the full benefits of the test.

About ProlarisProlaris is a genetic test developed by Myriad Genetics that directly measures tumor cell growth. The Prolaris test paired with other clinical and pathologic variables provides the level of aggressiveness of a patients individual prostate cancer and assesses risk of death or the development of metastatic disease from prostate cancer. For more information visit: http://www.prolaris.com.

About Myriad GeneticsMyriad Genetics Inc., is a leading genetic testing and precision medicine company dedicated to transforming patient lives worldwide. Myriad discovers and commercializes genetic tests that determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across medical specialties where critical genetic insights can significantly improve patient care and lower healthcare costs. For more information, visit the Company's website:www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor StatementThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the validation study presented during at ASCO-GU by Jonathan Tward M.D., Ph.D; expanding access so that every man who is facing difficult treatment decisions will be able to utilize the full benefits of the Prolaris test; and the Companys strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Assn for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Intl, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2020, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

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New Study from Leading University of Utah Radiation Oncologist Validates Ability of Myriad Genetics' Prolaris test to Guide Treatment for Prostate...

Dublin, Feb. 12, 2021 (GLOBE NEWSWIRE) -- The "Biobanking Market by Specimen Type, Type of Biobank, Ownership, and Application: Global Opportunity Analysis and Industry Forecast, 2020-2027" report has been added to ResearchAndMarkets.com's offering.

The global biobanking market was valued at $37. 93 billion in 2019, and is estimated to reach $57. 67 billion by 2027, growing at a CAGR of 4. 6% from 2020 to 2027.

Biobank is a biorepository meant to collect and preserve biological materials that are used for diagnosis, biodiversity studies, and research. In addition, it is used to support the research of most common types of genetic disorders to develop personalized medicines and to maintain and update database of diseases related to age.

The rise in funding by private & government organizations for biobanking and increase in application areas of bio banked samples are the major factors that drive the growth of the global biobanking market. Moreover, upsurge in incidence of diseases such as cancer significantly contributes toward the market growth, owing to the fact that biobanked specimens are used in the treatment of several chronic diseases. However, ethical issues related to biobanking and lack of awareness about it are expected to impede the market growth. On the contrary, advancements in stem cell research and unmet medical needs in emerging nations are anticipated to provide lucrative opportunity for the market expansion.

The rise in genomic research activities acts as a key driving force of the global market. Furthermore, government is taking multiple initiatives to support regenerative medicine research, which is expected to boost the market growth. Moreover, increase in demand for cost-effective drug delivery & development accelerates the market growth. Furthermore, usage of human biospecimens is increasing in cohort studies. Number of registered clinical studies with the National Institutes of Health (NIH) increased from 181,305 in 2014 to 262,445 in 2017. A substantial number of large ongoing cohort studies related to precision medicine have fomented the establishment of population-based banks.

The global biobanking market is segmented into specimen type, type of biobank, ownership, application, and region. Depending on specimen type, the market is categorized into blood products, solid tissue, cell lines, nucleic acid, and others. On the basis of ownership, it is divided into national/regional agencies, nonprofit organization, universities, and private organization. The applications covered in the study include therapeutic and research. By type of biobank, the market is bifurcated into population-based biobank and disease-oriented biobank. Region wise, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

Some of the major companies that operate in the global market for biobanks are BioIVT & Elevating Science, Geneticist Inc, Firalis S. A., AMS biotechnology Ltd. (AMSBIO LLC), and US Biolab Corporation, Inc., ProteoGenex, Inc., Cureline, Inc., Bay Biosciences LLC, CTI Biotech, and Boca Biolistics.

Key Benefits

Key Topics Covered:

Chapter 1: Introduction1.1. Report Description1.2. Key Benefits for Stakeholders1.3. Key Market Segments1.1. Research Methodology1.1.1. Secondary Research1.1.2. Primary Research1.1.3. Analyst Tools and Models

Chapter 2: Executive Summary2.1. Key Findings of the Study2.2. Cxo Perspective

Chapter 3: Market Overview3.1. Market Definition and Scope3.2. Key Findings3.2.1. Top Investment Pockets3.2.2. Top Player Positioning3.3. Porter'S Five Forces Analysis3.4. Market Dynamics3.4.1. Drivers, Restraints, and Opportunity3.4.2. Drivers3.4.2.1. The Rise in Funds for Biobanks3.4.2.2. Increase in R&D Activities for Application of Biobank Specimens3.4.2.3. Surge in Prevalence of Fatal Chronic Diseases3.4.3. Restraints3.4.3.1. Legal and Ethical Issues of Biobanking3.4.3.2. Lack of Awareness Toward Biobanking3.4.4. Opportunity3.4.4.1. High Growth Potential in Developing Countries3.5. Impact of Covid-19 on Biobanking Market3.5.1. Overview3.5.2. Impact Analysis3.5.3. List of 10 Largest Biobanks Across the Globe

Chapter 4: Biobanking Market, by Specimen Type4.1. Overview4.1.1. Market Size and Forecast4.2. Blood Products4.2.1. Key Market Trends and Opportunities4.2.2. Market Size and Forecast, by Region4.2.3. Market Analysis, by Country4.3. Solid Tissues4.3.1. Key Market Trends and Opportunities4.3.2. Market Size and Forecast, by Region4.3.3. Market Analysis, by Country4.4. Cell Lines4.4.1. Key Market Trends and Opportunities4.4.2. Market Size and Forecast, by Region4.4.3. Market Analysis, by Country4.5. Nucleic Acid4.5.1. Key Market Trends and Opportunities4.5.2. Market Size and Forecast, by Region4.5.3. Market Analysis, by Country4.6. Others4.6.1. Key Market Trends and Opportunities4.6.2. Market Size and Forecast, by Region4.6.3. Market Analysis, by Country

Chapter 5: Biobanking Market, by Type of Biobank5.1. Overview5.1.1. Market Size and Forecast5.2. Population-Based Biobanks5.2.1. Key Market Trends and Opportunities5.2.2. Market Size and Forecast, by Region5.2.3. Market Analysis, by Country5.3. Disease-Oriented Biobanks5.3.1. Key Market Trends and Opportunities5.3.2. Market Size and Forecast, by Region5.3.3. Market Analysis, by Country

Chapter 6: Biobanking Market, by Ownership6.1. Overview6.1.1. Market Size and Forecast6.2. National/Regional Agencies6.2.1. Key Market Trends and Opportunities6.2.2. Market Size and Forecast, by Region6.2.3. Market Analysis, by Country6.3. Nonprofit Organization6.3.1. Key Market Trends and Opportunities6.3.2. Market Size and Forecast, by Region6.3.3. Market Analysis, by Country6.4. Universities6.4.1. Key Market Trends and Opportunities6.4.2. Market Size and Forecast, by Region6.4.3. Market Analysis, by Country6.5. Private Organization6.5.1. Key Market Trends and Opportunities6.5.2. Market Size and Forecast, by Region6.5.3. Market Analysis, by Country

Chapter 7: Biobanking Market, by Application7.1. Overview7.1.1. Market Size and Forecast7.2. Therapeutic7.2.1. Key Market Trends and Opportunities7.2.2. Market Size and Forecast, by Region7.2.3. Market Analysis, by Country7.3. Research7.3.1. Key Market Trends and Opportunities7.3.2. Market Size and Forecast, by Region7.3.3. Market Analysis, by Country

Chapter 8: Biobanking Market, by Region8.1. Overview8.2. North America8.3. Europe8.4. Asia-Pacific8.5. LAMEA

Chapter 9: Company Profiles9.1. Ams Biotechnology Ltd. (Amsbio LLC)9.1.1. Company Overview9.1.2. Company Snapshot9.1.3. Operating Business Segments9.1.4. Product Portfolio9.2. Bay Biosciences LLC9.2.1. Company Overview9.2.2. Company Snapshot9.2.3. Operating Business Segments9.2.4. Product Portfolio9.3. Bioivt & Elevating Science9.3.1. Company Overview9.3.2. Company Snapshot9.3.3. Operating Business Segments9.3.4. Product Portfolio9.3.5. Key Strategic Moves and Developments9.4. Boca Biolistics9.4.1. Company Overview9.4.2. Company Snapshot9.4.3. Operating Business Segments9.4.4. Product Portfolio9.5. Cti Biotech9.5.1. Company Overview9.5.2. Company Snapshot9.5.3. Product Portfolio9.6. Cureline, Inc.9.6.1. Company Overview9.6.2. Company Snapshot9.6.3. Operating Business Segments9.6.4. Product Portfolio9.7. Firalis S. A.9.7.1. Company Overview9.7.2. Company Snapshot9.7.3. Operating Business Segments9.7.4. Product Portfolio9.8. Geneticist Inc.9.8.1. Company Overview9.8.2. Company Snapshot9.8.3. Operating Business Segments9.8.4. Product Portfolio9.9. Proteogenex, Inc.9.9.1. Company Overview9.9.2. Company Snapshot9.9.3. Operating Business Segments9.9.4. Product Portfolio9.10. Us Biolab Corporation, Inc.9.10.1. Company Overview9.10.2. Company Snapshot9.10.3. Operating Business Segments9.10.4. Product Portfolio

For more information about this report visit https://www.researchandmarkets.com/r/5gm10t

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Outlook on the Biobanking Global Market to 2027 - Opportunity Analysis and Industry Forecasts - GlobeNewswire

Chinese pharmaceutical and 3D printing technology firm Triastek has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its first 3D printed drug product, T19.

T19 has been developed in-house and is designed to treat rheumatoid arthritis, which is an autoimmune disease where the bodys immune system attacks the cells that line joints by mistake, making them stiff and swollen.

Triastek 3D printed the drug product using its Melt Extrusion Deposition (MED) technology platform and has global intellectual property (IP) rights to its 3D printed formulation.

Triastek is committed to improving the efficiency of formulation development, enhancing the effects of drug products, and ensuring the quality of drug delivered to patients by using the 3D printing technology platform, said Dr. Senping Cheng, Co-founder and CEO of Triastek. The FDA IND clearance of T19 is an important milestone in the development and application of MED 3D printing technology.

MED 3D printing platform

Triasteks MED 3D printing technology platform uses digital pharmaceutical dosage form design and automated intelligent manufacturing to enable the construction of tablets with sophisticated shapes and internal geometric structures. These structures allow the onset time, duration, and mode of drug delivery to be closely controlled and adjusted, which in turn provides more predictable and reproducible drug delivery results.

By enabling greater customization of the printed drugs, the MED system can help to enhance the therapeutic effects of medicines, while lowering side effects and improving compliance with patients. Triasteks novel pharmaceutical product development method, 3D formulation by Design (3DFbD) can be used in tandem with MED 3D printing technology to reduce the need for trial and error often required during traditional formulation development processes. 3DFbD is designed to improve both the efficiency and success rate of Triasteks drug product development in order to accelerate development time and lower costs.

The firm has also integrated real-time Process Analytical Technology (PAT) into the MED system that can continually monitor the 3D printing process to ensure product quality and make regulatory monitoring more convenient.

In April last year, the MED platform was accepted into the FDAs Emerging Technology Program (ETP) which recognized the 3D printing technology as a fully automated process for the manufacture of modified release solid oral dosage forms.

We believe that the MED 3D printing technology will be the enabler for digital pharmaceutical product development and intelligent drug manufacturing, said Dr. Xiaoling Li, Triasteks Co-founder and CSO. Triastek will work with any interested parties to take advantage of the platform technology for developing pharmaceutical products with better clinical value and higher product quality.

A chronotherapeutic drug delivery system

According to Triastek, deploying 3D printing for T19s novel design permits it to function as a chronotherapeutic drug delivery system. Chronotherapy treatment is based on the idea that administering medicine at different times of the circadian cycle the bodys natural internal process that regulates sleep over a 24 hour period will maximize a drugs therapeutic impact while minimizing side effects.

The T19 tablet is 3D printed on Triasteks MED system in a specific shape and with a precise internal geometric structure that facilitates the precise control of the drugs release to achieve the desired uptake by the patient. Taken at bedtime, T19s design means the drug will be released in a delayed manner so that blood concentration peaks when symptoms of pain and joint stiffness are most acute, such as in the early hours of the morning.

Having received IND clearance from the FDA for T19, Triastek is planning to apply for the same approval in China later this year, followed by applications in Japan and Europe. The firm expects to file a New Drug Application (NDA) for T19 to the FDA in 2023, and announced it has also developed a 505(b)(2) product portfolio using MED 3D printing technology to improve the outcomes of drug therapy.

3D printing and drug delivery

Personalized medication for individual patients is a fast-growing area of interest within the 3D printed pharmaceutical field. 3D printing enables the size and geometries of tablets and drug delivery devices to be modified to control their release and dosages depending on clinical need.

In 2015, Aprecia Pharmaceuticalsreceived FDA approvalfor its 3D printed Spiritam medication, making it the first 3D printed pharmaceutical to be approved by the FDA. The medication is designed to treat seizures in people with epilepsy and was approved for commercial manufacturing operations later that year. Aprecia recently announced a long-term collaboration with R&D firm Battelle to expand its capabilities within 3D printed pharmaceuticals and advance its 3D printing equipment from clinical supply to commercial scale. The firm has also previously partnered with Cambridge-basedCycle Pharmaceuticalsto produce orphan drugs for thetreatment of rare medical conditionsusing its ZipDose 3D printing process.

3D printed pharmaceuticals firm FabRx has also been active on the printed drug development front, having produced personalized medicine for children with the rare metabolic disorder maple syrup urine disease (MSUD), and printed its chewable Printlet tablets with Braille and Moon patterns on the surface to aid medicine taking for patients with visual impairment. The company launched its M3DIMAKER 3D printer in April 2020, designed specifically for the manufacture of personalized drug delivery devices.

Elsewhere, global pharmaceutical firm Merck has announced plans to work with EOS Group company ACMC to produce 3D printed tablets first for clinical trials, then later for commercial manufacturing. Meanwhile, in the research realm 3D printing has been used to optimize the controllable dosage of antibiotic tablets, and semi-solid extrusion 3D printing has been explored as a coating technology for customizing the release rate of patient-specific drugs.

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Featured image showsTriastek has gained IND clearance from the FDA for its T19 drug for rheumatoid arthritis. Image via Triastek.

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Triastek receives FDA IND clearance for 3D printed drug to treat rheumatoid arthritis - 3D Printing Industry

Newswise George Mason UniversitysCollege of Scienceannounced an exciting $1.33 million collaboration withRutgers Cancer Institute of New Jerseyand Masons Center for Applied Proteomics and Molecular Medicine (CAPMM) which taps cancer research diagnostics and treatment strengths within the medical facilities and CAP/CLIA laboratory respectively of the two regional powerhouses.

The effort will use a new way to measure biomarkers of the HER2 protein, which is expressed on breast cancer cells. Women who have this protein get specific therapies, now part of the standard of care in both early stage and metastatic settings of breast cancer.

The projects overall goal is clinical validation, in two independent patient cohorts from the Rutgers Cancer Institute, of a new way for measuring HER2 based on its activation (phosphorylation) and predicting, using only the patients diagnostic biopsy, whether or not that patient will respond favorably to the treatment.

The Mason-developed test uses a new Fluidigm laser capture microdissection (LCM), which enables researchers to capture cellular regions of interest from frozen and FFPE tissue sections for downstream analysis using DNA and RNA sequencing, real-time PCR or mass spectrometry analysis. The test is designed for patients with HER2 positive breast tumors to predict if each patient will achieve a complete remission of the tumor so that the tumor is completely absent and cannot even be found on pathologic tissue examination.

We aim to emerge from this short-term, high-impact effort with established cut-points, reagents, and CLIA/CAP SOPs developed and validated for our assay that would be published for general use, saidLance Liotta, MD, PhD, study PI, and CAPMM co-founder and co-director.

During the first year of the partnership, researchers will measure HER2 activation retrospectively on previously collected cancer specimens and cross reference it with treatment outcomes. During the second year, those findings will help inform the design of prospective trials enabling real-time decision making influencing the selection of future therapy options offered to patients at Rutgers Cancer Institute and RWJBarnabas Health.

We believe the test can have great benefit for individualizing therapies, added, Dr. Emanuel Petricoin, PhD, Co-PI of the study and also co-founder and co-director of Mason CAPMM. Clinical studies have supported the recent approval of two escalation strategies, unfortunately, these escalations are associated with considerable increased costs and additional risks of toxicity, Petricoin explained.

Therefore, careful and accurate patient risk stratification up-front, to identify which patients will benefit most from treatment, is essential to minimize risk and maximize benefit, said Rutgers Cancer Institutes principal investigator,Shridar Ganesan, MD, PhD, chief of molecular oncology, associate director for translational research, and Omar Boraie Chair in Genomic Science.

If validated, this predictor may help lead to development for modified or, de-escalated regimens for patients who score at low risk for recurrence or high chance of complete pathologic response Similarly, patients who score at high risk of recurrence or low chance of complete pathologic response from current standard therapy may benefit from trials exploring other treatment approaches.

The tests will be conducted on the pretreatment biopsy tissue we have collected and directly evaluate the molecular target of the major classes of HER2 neoadjuvant therapies, said Ganesan, a professor of medicine and pharmacology at Rutgers Robert Wood Johnson Medical School who had previously collaborated with Liotta while he was at the NIH.

This partnership allows us to continue to provide the most advanced treatment options possible for our patients, Ganesan added.

The teams plan also includes a rapid deployment of the testing if it proves conclusive.

Weve partnered with Theralink Diagnostics, Inc. who will be responsible for the assay commercialization and expanded clinical assessment to provide an accelerated adoption and clinical use by medical oncologists, saidEmanuel Petricoin, CAPMM co-director, and a scientific advisor to the Company. We have set up the infrastructure to quickly deploy the information and technology; if this holds true, we have a commercial partner ready to take it to the bedside as part of a patient clinical care plan and treatment decision support tool, Petricoin explained.

This is a smart, strategic partnershipboth Rutgers and Mason each bring invaluable expertise and infrastructure to minimize time to market and maximize research impact, said Mason College of Science dean, Fernando Miralles-Wilhelm. Mason scientists created the protein measurement test and offer CAP/CLIA facilities that dovetail well with the existing biobank of tissue samples and preeminent therapeutic cancer treatments options offered to patients at Rutgers Cancer Institute of New Jersey, Miralles-Wilhelm added.

The College of Science at George Mason University

Mason's College of Science is a leader in scientific discovery and a creator of innovative solutions for the rapidly-changing needs of today's world. The college prides itself in being home to a diverse population of students and researchers serving as a magnet for all scientific minds. With new discoveries, our scientists continue to grow Mason's portfolio of patents, licenses, partnerships, and spin off companies.

The college blends traditional science education with sought-after programs at all levels to challenge and engage in disciplines including personalized medicine, infectious diseases, drug discovery, climate dynamics, environmental justice and conservation, materials science, astronomy, forensic science, computational science, and applied mathematics. Mason's College of Science offers enhanced undergraduate and graduate academic and research opportunities, including innovative minors, certificates, and graduate degrees, that allow professionals to upskill or change careers. Learn more atscience.gmu.edu

About George Mason University

George Mason University is Virginia's largest public research university. Located near Washington, D.C., Mason enrolls more than 39,000 students from 130 countries and all 50 states. Mason has grown rapidly over the last half-century and is recognized for its innovation and entrepreneurship, remarkable diversity, and commitment to accessibility. Visithttp://www.gmu.edu

About Rutgers Cancer Institute of New Jersey

As New Jersey's only National Cancer Institute-designated Comprehensive Cancer Center, Rutgers Cancer Institute, together with RWJBarnabas Health, offers the most advanced cancer treatment options including bone marrow transplantation, proton therapy, CAR T-cell therapy and complex surgical procedures. Along with clinical trials and novel therapeutics such as precision medicine and immunotherapy - many of which are not widely available - patients have access to these cutting-edge therapies at Rutgers Cancer Institute of New Jersey in New Brunswick, Rutgers Cancer Institute of New Jersey at University Hospital in Newark, as well as through RWJBarnabas Health facilities. Learn more atcinj.org

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Mason Scientists and Rutgers Cancer Institute of New Jersey Collaboration Receives U.S. Armys Breakthrough Award to Better Inform HER2 Breast Cancer...

DUBLIN--(BUSINESS WIRE)--The "Companion Diagnostic Markets - the Future of Diagnostics, by Funding Source and Application with Customized Forecasting/Analysis, COVID-19 Updates, and Executive and Consultant Guides 2021-2025" report has been added to ResearchAndMarkets.com's offering.

Will Personalized Companion Diagnostics become the norm for diagnostics?

Companion Diagnostics are poised to revolutionize the diagnostics industry. The market is finally moving out of the lab and into the clinic. Oncology, especially immune-oncology is leading the way. And the FDA is holding the door open for this diagnostic technology of the future. But COVID-19 is impacting healthcare treatment everywhere and lowering demand for specialized cancer testing. Find out the latest outlook for this important market.

Learn all about how diagnostic players are jockeying for position with their pharmaceutical counterparts and creating new and significant business opportunities. And some players are already taking the lead. It is a dynamic market situation with enormous opportunity. Diagnostic companies are trying to back the right horse. The science is racing forward. And the cost of molecular diagnostics continues to fall.

Key Topics Covered:

Companion Diagnostic Market - Strategic Situation Analysis

1. Introduction and Market Definition

1.1 What are Companion Diagnostics?

1.2 The Personalized Medicine Revolution

1.3 Market Definition

1.4 Methodology

1.5 A Spending Perspective on Clinical Laboratory Testing

2. Market Overview

2.1 Players in a Dynamic Market

2.1.1 Academic Research Lab

2.1.2 Diagnostic Test Developer

2.1.3 Instrumentation Supplier

2.1.4 Distributor and Reagent Supplier

2.1.5 Independent Testing Lab

2.1.6 Public National/regional lab

2.1.7 Hospital lab

2.1.8 Physician Office Labs

2.1.9 Audit Body

2.1.10 Certification Body

2.2 Personalized Medicine and Companion Diagnostics

2.2.1 Basics

2.2.2 Method

2.2.3 Disease risk assessment

2.2.4 Applications

2.2.5 Diagnosis and intervention

2.2.5.1 Companion Diagnostics

2.2.6 Drug development and usage

2.2.7 Respiratory proteomics

2.2.8 Cancer genomics

2.2.9 Population screening

2.2.10 Challenges

2.2.11 Regulatory oversight

2.2.12 Intellectual property rights

2.2.13 Reimbursement policies

2.2.14 Patient privacy and confidentiality

2.3 Chromosomes, Genes and Epigenetics

2.3.1 Chromosomes

2.3.2 Genes

2.3.3 Epigenetics

2.4 Cancer Genes

2.4.1 Germline vs Somatic

2.4.2 Changing Clinical Role

2.5 Structure of Industry Plays a Part

2.5.1 New Pharmaceutical Funding Market

2.5.2 Economies of Scale

2.5.2.1 Hospital vs. Central Lab

2.5.3 Physician Office Labs

2.5.4 Physicians and POCT

3. Market Trends

3.1 Factors Driving Growth

3.1.1 Level of Care

3.1.2 Immuno-oncology

3.1.3 Liability

3.1.4 Aging Population

3.2 Factors Limiting Growth

3.2.1 State of knowledge

3.2.2 Genetic Blizzard.

3.2.3 Protocol Resistance

3.2.4 Regulation and coverage

3.3 Instrumentation and Automation

3.3.1 Instruments Key to Market Share

3.3.2 Bioinformatics Plays a Role

3.4 Diagnostic Technology Development

3.4.1 Next Generation Sequencing Fuels a Revolution.

3.4.2 Single Cell Genomics Changes the Picture

3.4.3 Pharmacogenomics Blurs Diagnosis and Treatment

3.4.4 CGES Testing, A Brave New World

3.4.5 Biochips/Giant magneto resistance based assay

4. Companion Diagnostics Recent Developments

4.1 Recent Developments - Importance and How to Use This Section

4.1.1 Importance of These Developments

4.1.2 How to Use This Section

5. Profiles of Key Players

6. The Global Market for Companion Diagnostics

6.1 Global Market Overview by Country

6.2 Global Market by Application - Overview

6.3 Global Market Funding Source - Overview

7. Global Companion Diagnostic Markets - By Application

7.1 Oncology

7.2 Neurology

7.3 Cardiology

7.4 Other Application

8. Global Companion Diagnostic Markets - Funding Source

8.1 Global Market Pharmaceutical

8.2 Global Market Venture

8.3 Global Market Clinical

8.4 Global Market Other Funding

For more information about this report visit https://www.researchandmarkets.com/r/f07ek

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Global Companion Diagnostic Markets Report 2021: A Steep Growth Curve Interrupted by COVID-19 - Forecast to 2025 - ResearchAndMarkets.com - Business...

WALTHAM, Mass.--(BUSINESS WIRE)--BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, and Weill Cornell Medicine, today announced a publication in Cancer Discovery, a journal of the American Association for Cancer Research. The manuscript Clinical and biological subtypes of B-cell lymphoma revealed by microenvironmental signatures highlights the tumor microenvironment as a critical component of B-cell lymphoma biology and the effects of different microenvironments on diffuse large B-cell lymphoma (DLBCL) clinical behavior, establishing a significant opportunity for the development of novel and personalized therapeutic strategies for this disease.

In this research study, the microenvironment subtypes of over 4,600 DLBCL patients were classified using curated and refined transcriptional signatures encompassing key microenvironment and cancer cells activities and processes. This analysis revealed four distinct DLBCL microenvironments (LMEs), each with its own set of unique biological and clinical properties. The LMEs were also found to correlate with different clinical outcomes and prognoses, and downstream preclinical mechanistic studies demonstrated that the LMEs could be applied in clinical decision-making for DLBCL patients.

This study was designed to evaluate the role of the tumor microenvironment in DLBCL biology, said Leandro Cerchietti, M.D., Associate Professor of Medicine and a member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine. The results revealed distinct DLBCL microenvironments with unique therapeutic vulnerabilities that can be utilized for optimization of DLBCL treatment strategies.

The data demonstrate that this novel classification platform provides a roadmap for the therapeutic exploitation of the tumor microenvironment in DLBCL patients, said Nathan Fowler, MD, Chief Medical Officer at BostonGene. Together with Weill Cornell Medicine, we look forward to identifying new treatment strategies to ultimately improve the clinical outcomes of these patients.

About BostonGene Corporation

BostonGene Corporation is pioneering the use of biomedical software for advanced patient analysis and personalized therapy decision making in the fight against cancer. BostonGenes unique solution performs sophisticated analytics to aid clinicians in their evaluation of viable treatment options for each patient's individual genetics, tumor and tumor microenvironment, clinical characteristics and disease profile. BostonGenes mission is to enable physicians to provide every patient with the highest probability of survival through optimal cancer treatments using advanced, personalized therapies. For more information, visit BostonGene at http://www.BostonGene.com.

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BostonGene and Weill Cornell Medicine Announce Publication in Cancer Discovery Revealing the Role of the Tumor Microenvironment in the Clinical...

MINNEAPOLIS, Feb. 08, 2021 (GLOBE NEWSWIRE) -- Predictive Oncology (NASDAQ: POAI), a knowledge-driven company focused on applying artificial intelligence (AI) to personalized medicine and drug discovery, announced today that it will start an in-house drug repurposing project, focused on ovarian cancer, using its proprietary AI-driven, patient centric discovery platform PeDAL. The project will use PeDAL to rapidly and cost-effectively profile panel of existing drugs against hundreds of patient cell lines. This process will generate data on which compounds are active against which specific patient profile(s), delivering both proof data for the PeDAL approach and valuable Intellectual Property (IP) for the company.

With our Helomics divisions deep experience in clinical profiling of patient tumor drug response, plus our unique PeDAL platform, we have all the components to perform in-house drug repositioning and even full drug discovery. We are very excited to kick-off this first project focused on ovarian cancer. Our expectations are that the project will have significant value by generating proof data for our PeDAL approach, which will be useful in our commercial discussions with Pharmaceutical companies. In addition, the project will also demonstrate the long-term value of Helomics unique data, explained Dr. Carl Schwartz, CEO of Predictive Oncology.

Looking forward, we strongly believe successful execution of this project will demonstrate that Predictive Oncology is emerging as a leader in AI-driven drug discovery, commented Dr. Schwartz.

About Predictive Oncology Inc.

Predictive Oncology (NASDAQ: POAI) operates through three segments (Skyline, Helomics and Soluble Biotech), which contain four subsidiaries: Helomics, TumorGenesis, Skyline Medical and Soluble Biotech.

Helomics applies artificial intelligence to its rich data gathered from patient tumors to both personalize cancer therapies for patients and drive the development of new targeted therapies in collaborations with pharmaceutical companies. TumorGenesis Inc. specializes in media that help cancer cells grow and retain their DNA/RNA and proteomic signatures, providing researchers with a tool to expand and study cancer cell types found in tumors of the blood and organ systems of all mammals, including humans. Skyline Medical markets its patented and FDA cleared STREAMWAY System, which automates the collection, measurement, and disposal of waste fluid, including blood, irrigation fluid and others, within a medical facility, through both domestic and international divisions. Soluble Biotech is a provider of soluble and stable formulations for proteins including vaccines, antibodies, large and small proteins, and protein complexes.

Forward-Looking Statements

Certain matters discussed in this release contain forward-looking statements. These forward-looking statements reflect our current expectations and projections about future events and are subject to substantial risks, uncertainties and assumptions about our operations and the investments we make. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue and financial performance, projected costs, prospects, plans and objectives of management are forward-looking statements. The words anticipate, believe, estimate, expect, intend, may, plan, would, target and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our actual future performance may materially differ from that contemplated by the forward-looking statements because of a variety of factors including, among other things, factors discussed under the heading Risk Factors in our filings with the SEC. Except as expressly required by law, the Company disclaims any intent or obligation to update these forward-looking statements.

Investor Relations Contact:

Landon Capital Keith Pinder (404) 995-6671kpinder@landoncapital.net

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Predictive Oncology's Wholly Owned Subsidiary Helomics announces the start of its drug repurposing project using its ground-breaking PeDAL platform...

The collaboration with the Spanish Lung Cancer Group (Grupo Espaol de Cncer de Pulmn GECP), a Spanish cooperative group for the research on lung cancer, is to show the potential of SOPHiA Radiomics a groundbreaking application that analyzes medical images for research use put to use in an additional retrospective analysis of the data from the phase 2 NADIM clinical trial (NCT03081689) (the NADIM trial).

The NADIM trial, funded by Bristol-Myers Squibb and part of the European Union's Horizon 2020 research and innovation program, aimed to assess the antitumor activity and safety of neoadjuvant chemoimmunotherapy for resectable stage IIIA NSCLC. The important results recently published in TheLancet Oncology supported the addition of neoadjuvant nivolumab to platinum-based chemotherapy in patients with resectable stage IIIA NSCLC. This very aggressive type of cancer is unfortunately terminal in most patients with locally advanced staged disease; these results could therefore support a change of perception of locally advanced lung cancer as a potentially lethal disease to one that is curable.

Additional data are expected to be generated through the analysis of the radiology images of NADIM patients through the SOPHiA Radiomics Platform. These data will then be combined with clinical, biological, and genomics data, and multimodal machine learning models will be developed to predict response to neoadjuvant treatment, using baseline and pre-surgery data. The predictive analysis will also aim to stratify patient cohorts with regard to progression-free and overall survival.

"We are very happy to collaborate in this innovative and revolutionary project that opens the door to a new precision medicine. Certainly, this partnership will improve the knowledge relating to the treatment for this group of patients and will allow to approach the best prospects for curing early-stage non-small cell lung cancer (NSCLC)," said Dr. Mariano Provencio, Head of the Medical Oncology Department at Puerta de Hierro University Hospital in Madrid and lead investigator of the NADIM trial.

"We are very excited to apply our radiomics and multimodal analytics capabilities to such an important clinical question," said Prof. Thierry Colin, Vice-President of Radiomics Research at SOPHiA GENETICS. "In the Spanish Lung Cancer Group, we have found visionary partners that clearly see the promise of next-generation health data such as radiomics being married with tech-enabled solutions in artificial intelligence to generate entirely novel clinical insights for the benefit of oncology patients."

"Unlocking the synergistic potential of multimodal health data through artificial intelligence holds revolutionary promise for the future of personalized medicine in oncology and many other health conditions. We are inspired by the potential to positively impact on patients by supporting their care providers in predicting the best course of treatment," said Dr. Philippe Menu, Chief Medical Officer at SOPHiA GENETICS.

The NADIM trial involved 18 centers from the Spanish Lung Cancer Network that will contribute their data to the joint project.

Results from the additional analysis of NADIM trial data are expected to be available later this year.

About SOPHiA GENETICS

SOPHiA GENETICS is a health tech company democratizing Data-Driven Medicine to improve health outcomes and economics worldwide. By unlocking the power of new-generation health data for cancer and rare diseases management, the universal SOPHiA Platform allows clinical researchers to act with precision and confidence. The company's innovative approach enables an ever-expanding community of over 1,000 institutions to benefit from knowledge sharing, fostering a new era in healthcare. SOPHiA's achievement is recognized by the MIT Technology Review's "50 Smartest Companies".

More info: SOPHiAGENETICS.COM, follow @SOPHiAGENETICS on Twitter.

About the Spanish Lung Cancer Group

The SLCG is an independent, non-profit, cooperative group founded in 1991 to promote the study and research of lung cancer. The group is composed of 525 medical professionalsoncologists, thoracic surgery specialists, radiotherapists and basic researchersand unites 177 public and private centers across Spain.The group has treated over 37,000 patients in different studies and clinical trials, the results of which have been presented and published at national and international congresses and in leading medical journals.

More info: gecp.com, follow @gecp_org on Twitter.

SOPHIA GENETICS Media ContactSophie ReymondPR & Communications Manager [emailprotected]+41 79 863 11 10

SLCG ContactRita Perales [emailprotected] +34 670 24 70 50

SOURCE SOPHiA GENETICS

https://www.sophiagenetics.com/

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SOPHiA GENETICS and the Spanish Lung Cancer Group Team Up to Explore the Predictive Potential of Multimodal Health Data in Resectable Stage IIIA...

In recent years, the idea of the microbiome has gone from being an esoteric term used in scientific circles, to a mainstream concept employed in adverts to sell microbiome-boosting health drinks and supplements. The increase in public interest has been fed by a series of headline-grabbing research breakthroughs, and the fact that the microbiome has a key role to play in the development of precision medicine.The trillions of microbes contained in the human body are a key element of a personalized approach to treatment; the microbiome influences endocrinology, physiology, and even neurology, and has a crucial role in disease progression. The growing awareness of the various ways in which microbiota affects each of us individually in sickness and in health is also leading to an increase in research. An area in which this interest is growing particularly quickly is oncology.

Multiple publications implicate microbiota in the onset and progression of cancers, as well as toxicity and the response rate of cancer treatments. An analysis of 12 million full-text publications, 29 million abstracts and 521 thousand grant applications for semantic relations between cancers and microbiota is shown in figure 1. The data show a considerable increase in the number of articles linking cancers to microbiota for five cancer types with the highest number of reports overall.

Figure 1.Trend of reports linking cancers to microbiota 20082019. Credit: Graph generated using Elsevier Text Mining and Scopus.

With overall cancer rates set to increase worldwide, the current interest in the microbiome and its role in precision medicine is likely to continue because it offers new hope of treatments. Evidence suggests the importance of looking for predictors of therapeutic response beyond the tumor by focusing on host factors, such as microbiota and host genomics.1 Importantly, the microbiota is a modifiable factor, and potentially can become not just a predictive marker but also a potential target in order to improve outcomes for patients.

Progress is also being made in clinical trials looking at the microbiome and melanoma. Since 2018, four clinical trials that aim to study and modulate the gut microbiomes impact on response to immunotherapy of melanoma have been registered at clinicaltrials.gov. Dr Marc Hurlbert, Chief Science Officer for the Melanoma Research Alliance, commented on the findings: As noted in the report, there has been an explosion of knowledge about melanoma with an ever-increasing list of protein targets. Also noted, the role of the microbiome in melanoma and in response to immunotherapy is of increasing interest in the field.

To further develop targeted precision therapies, further research is now required. Firstly, to map genetic variants; secondly, to determine which variant is clinically significant; thirdly, to understand the impact of variant on gene function, and whether variation activates or inhibits the gene. This is particularly important for increased understanding of specific, precision medicine and to enhance therapeutic efficacy.

For non-hereditary (sporadic) melanoma, the analysis showed that there are 752 genes genetically linked to sporadic melanomas and its subtypes, and 449 genetic variants genetically linked to sporadic melanoma and its subtypes. Out of the 449 genetic variants, 395 are from 78 genes that are genetically linked to melanoma. The remaining missing 54 variants are not currently genetically linked in the platform to any known melanoma gene; this could therefore be a potential area for further research.

Understanding whether specific genetic variants exist and/or contribute to melanomas severity and prevalence in populations will help the research and development (R&D) industry to develop more effective and profitable therapeutics. These types of data will provide the R&D community with a greater depth of understanding and of the increased likelihood of hitting the target. Through our analysis we found an increased incidence of drugs targeting genetic mutations over the last decade, particularly targeting protein kinases and growth factor receptors.

It is an attractive future research avenue to recognize how a patients microorganisms genome, both symbiotic and pathogenic, can dramatically effect treatment plans and outcomes. Positively influencing the microbiome in patients needs further study that could lead to exciting opportunities for patients and for drug discovery. For the therapeutic pipeline it would be beneficial to understand these host-microbiota interactions and ways to positively tip the balance towards improving treatment outcomes.

One other interesting future consideration during drug development for all cancers is the influence of the microbiome on treatment-induced adverse events, and whether clinical and post-clinical adverse events are related to a patients microbial composition. It adds a level of complexity as to the efficacy of therapeutics that may not readily be considered, and potentially may be something to consider during future clinical trials.

Moreover, in the current COVID-19 era, in-person and patient interactions are reduced and many research labs are still unable to operate at full capacity. The ability to conduct research, take samples and study real patients is limited at present, so looking at detailed existing literature and data is a vital avenue to support R&D. It will keep R&D functions going and help them to direct efforts to the areas of greatest potential. 2021 will be a year of reduced R&D budgets globally this type of data insight will be vital to empowering future R&D.

Tom is the Life Sciences Group Manager of Project Management, Knowledge Manager, and Research Scientist. He has extensive experience as an academic researcher in neurodegeneration and Alzheimers disease. He is also skilled in biophysical chemistry, dementia disorders, and biochemistry. He is the author of many publications in the field of protein-membrane interactions, protein misfolding, and Alzheimers disease. At Elsevier he delivers and implements information solutions for customers.

Tom discusses the study and unmet needs in melanoma R&D in detail, here, alongside Marc Hurlbert, Ph.D. Chief Science Officer, Melanoma Research Alliance.

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Exploring the Relationship Between the Microbiome, Precision Medicine and Cancer - Technology Networks

Artificial Intelligence (AI) continues to evolve and to incorporate its way into our lives. Versions of AI now routinely tell Americans where to eat, what routes to take, and what movies to watch. Artificial Intelligence isalso making in-roads into medical decision-making, asdiagnosis and treatment recommendations become more personalized. That has raised concerns from some commentators, who have suggested that Americas tort law system could prove a problematic fit with medical AI. If jurors see the act of listening to the computer as something that deviates from a doctors judgment and standard of care, than machine-centered advice could increase or complicate medical liability risk.

Researchers (Price, Gehrke & Cohen, 2021) looked at that question of whether juror attitudes might be a barrier to reliance on medical AI. The article, How Much Can Potential Jurors Tell Us About Liability for Medical Artificial Intelligence? focused on the circumstances under which jurors would hold a physician liable for following or not following an AI recommendation. Testing the response of the juror-eligible population to four scenarios, they found that following the AI recommendation does not appear to create unique liability risks for the physician: The experiments suggest that the view of the jury pool is surprisingly favorable to the use of AI in precision medicine. As a result, they concluded thatcivil liability is unlikely to hinder the acceptance of medical AI, at least not based on fear that jurors will distrust it. In this post, Ill look at the research and its implications.

The Research: Doctors Arent More Liable if They Listen to AI

The research emerged in response to the fear that medical AI could be like the driverless car, with people thinking, I can see how that would work in theory but Im not ready for technology to be making those decisions.The attitude, termed algorithm aversion relates to the perceived loss oflocus of controlin deferring our judgments to technology, even when that technology might be more resistant to human error.

To test whether this applies to medical AI, the research team conducted anonline experiment with a representative sample of 2,000 American adults. Participants reacted to one of four scenarios in which an ovarian cancer patient is given recommendations from a medical AI system called Oncology-AI, that advice is either for standard or nonstandard care, and the physician either accepts or rejects the AI recommendation.

The results suggest that jurors tend to favorbothstandard treatment, as well as following the AI recommendation. However, the physicians judgment does not automatically trump the AI recommendation, and physicians may be judged more harshly for rejecting the advice of a state-of-the-art tool. That mattered even when the AI recommendation was nonstandard: If physicians receive a nonstandard AI recommendation, they do not necessarily make themselves safer from liability by rejecting it.

The bottom line is that, all other things being equal, doctors tend to reduce their liability by accepting, rather than rejecting, the advice from AI.

The Implication: It Is About Normalization

The main implication is that tort law doesnt impose as much of a barrier to medical AI as some have suggested. One reason for that might be the increasing normalization of AI technology. As the article discusses, jurors focus on what seems normal, and theyre encouraged to do that based on definitions of the standard of care: Jurors evaluate what the normal or average physician would do. So, if high technology tools are not surprising in a medical context, then the typical conventional physician should adhere to these tools.

That, of course, doesnt mean that an AI recommendation will be right every time, or that blindly following it is the way to reduce liability, but it does suggest that a plaintiffs theme focusing purely on substituted judgment (i.e. she surrendered her own medical choices and just let the machine chose)may not be successful. After all, doctors are expected to use the best technology, anddisregardingthat advice might be riskier in the long run. The authors predict As AI becomes more common, any tort law incentive to accept AI recommendations will only strengthen further.

The broader point is that jurors tend to look for what fits within the range of expected and normal actions. Even in non-AI related cases, physicians will have a strong incentive to teach the jury what is typical and to normalize the knowledge, choices, and actions of the defendant.

____________________

Price, W. N., Gerke, S., & Cohen, I. G. (2021). How Much Can Potential Jurors Tell Us About Liability for Medical Artificial Intelligence?. Journal of Nuclear Medicine, 62(1), 15-16.

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Consider the AI Influence on Medical Liability | Holland & Hart - Persuasion Strategies - JDSupra - JD Supra

CHARLOTTESVILLE, Va., Jan. 28, 2021 /PRNewswire/ --MicroGEM, a Virginia-based molecular diagnostics company, today announced its acquisition of Jump Start Manufacturing LLC (Jump Start), a New Hampshire-based engineering company with proven success in the biotech and pharmaceutical industry. The acquisition allows MicroGEM to rapidly scale production of its innovative Spitfire6830 SARS-CoV-2 testing system, a high-performance, PCR-based point-of-need saliva test.

In addition to its pilot-scale manufacturing facility in Charlottesville, MicroGEM announced it has established new large-scale production facilities in Ogden, Utah, and Hudson, New Hampshire, expanding its manufacturing in the U.S. with plans to create more than 500 jobs between both locations. The facilities, with more than 120,000 square feet combined, give MicroGEM the capability of producing 160,000 tests per day.

"We are proud to join forces with the talented Jump Start team to accelerate the production and deployment of our innovative Spitfire6830 SARS-CoV-2testing system," said MicroGEM CEO Jeff Chapman. "Bringing Jump Start's leading manufacturing capabilities and expertise under the MicroGEM umbrella and dramatically expanding our production capabilities will ensure that more Americans have greater access to high-quality COVID-19 tests bringing key tools to help end this devastating pandemic."

MicroGEM's Spitfire6830 system is designed to detect SARS-CoV-2 in both symptomatic and asymptomatic individuals. The system is in final stages of development with preparations underway for submission to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization.

"The unique capability of the Spitfire6830 to quickly provide highly sensitive and specific identification of SARS-CoV-2 from saliva samples puts MicroGEM at the cutting edge of point-of-need diagnostics," said Jump Start founder, Thomas Moran, who joins MicroGEM as Chief Operations Officer overseeing all manufacturing activities. "Jump Start is thrilled to join the MicroGEM team, enabling us to help bring this low-cost, high-quality test to market while ensuring our Jump Start customers continue to receive the high-touch service they expect and deserve."

MicroGEM's Spitfire project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADx)initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92020C00015.

About Jump Start

Based in Nashua, New Hampshire, Jump Start is an engineering company established in 2006 with a successful record managing product launches for a variety of biotech and pharmaceutical companies, with expertise in medical devices. Jump Start offers a full range of engineering solutions, including machine design, manufacturing engineering, and a mechanical engineering laboratory, quickly implementing manufacturing solutions and process improvements with 'concierge-style' service. Jump Start's manufacturing expertise includes complex projects such as self-heating products, high precision medical infusion systems, and drug delivery systems. Under the MicroGEM umbrella, Jump Start will continue to provide all existing services to its customers with no interruption while increasing its capacity to offer a wider breath of capabilities to its clients.

About MicroGEM

MicroGEM is democratizing molecular diagnostics by moving molecular techniques out of conventional, highly skilled laboratories to non-laboratory settings. The company's innovative enzymatic approach to nucleic acid extraction provides the foundation for rapid sample preparation suitable for PCR analysis. Coupled with MicroGEM's expertise in microfluidics and synthetic biology, the company is creating the next generation of rapid, point-of-need diagnostic solutions for the management of infectious diseases and other personalized medicine applications.

To learn more about job openings at MicroGEM, visit https://microgembio.com/jobs/.

Visit http://www.microgembio.com and connect with us on LinkedInand Twitter.

Contact: Liz Halloran[emailprotected] 202-253-2656

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MicroGEM Acquires Jump Start, Expands Manufacturing To Accelerate Production Of Portable COVID-19 Saliva Test - PRNewswire

Jan. 26, 2021 12:00 UTC

Funding Supports Aclipse Therapeutics and Sheffield Institute of Translational Neurosciences Development of M102 in Amyotrophic Lateral Sclerosis

RADNOR, Pa.--(BUSINESS WIRE)-- Aclipse Therapeutics (Aclipse or the Company), a private biopharmaceutical company, today announced that the Company and its collaborator, The Sheffield Institute for Translational Neuroscience (SITraN) at the University of Sheffield in the United Kingdom (UK), were awarded a drug development research grant of 1.6 million (approximately US $2.2 million) from the UKs Medical Research Council (MRC), one of the largest funders of medical research worldwide, to support the translational development of M102. M102 is Aclipses drug candidate for the treatment of amyotrophic lateral sclerosis (ALS), also referred to as motor neuron disease (MND) or Lou Gehrigs disease.

M102 is a potentially disease-modifying drug candidate that has shown promise to impede ALS disease progression in a wide array of preclinical models. Currently, there is no cure for ALS and there are no effective treatments to halt or slow the progression of the disease.

This development funding from MRC is wonderful news for ALS/MND patients who are in dire need of an effective therapy to address this life-threatening neurodegenerative disease, stated Professor Dame Pamela Shaw, M.D., Director of SITraN and a primary contributor to M102s development program. Along with my SITraN colleagues, Dr. Richard Mead and Dr. Laura Ferraiuolo, we spearheaded the ALS/MND biology research that led to the development of M102, including the discovery of a potential precision medicine approach for M102 in ALS/MND, so we are very appreciative of MRCs funding support.

Aclipse is taking a multiple biological pathway, multiple disease mechanism approach to ALS. M102 activates the NRF2 (nuclear factor erythroid 2-related factor 2) and HSF1 (Heat shock factor 1) signaling pathways, which are recently understood to impact ALS pathophysiology. M102 is expected to be mechanistically superior to currently available drugs and may lead to significant slowing of disease progression in both familial and sporadic ALS.

The MRC grant will also support the development of patient stratification biomarkers that will be applied in the M102 clinical studies, potentially enabling a personalized medicine approach in ALS. The goal of the patient stratification biomarkers is to identify M102 drug responders versus non-responders in order to target M102 to those ALS patients most likely to benefit from the drug.

We greatly appreciate the support from MRC for our novel and broad multi-disease patho-mechanism approach to treating ALS patients, said Raymond K. Houck, CEO of Aclipse Therapeutics. The MRC award, coupled with our recent FightMND grant award, accelerates M102s development into its first-in-human clinical studies and validates M102s biology and potential for a precision medicine approach for the treatment of ALS.

The research funding from these programs will be key as they will support the completion of our investigational new drug (IND)-enabling work and the regulatory filings for first-in-human studies. Importantly, M102 may have applications in a wide array of conditions associated with impaired neuronal function such as Friedreichs ataxia, Huntingtons disease and Parkinsons disease, added Mr. Houck.

About ALS/MND Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND) or Lou Gehrig's disease, is a progressive neurodegenerative disease that affects motor neurons (nerve cells) in the brain and the spinal cord. Eventually, people with ALS lose the ability to initiate and control muscle movement, which often leads to total paralysis and death within two to five years of diagnosis. There is no cure and limited life-prolonging treatments for the disease. Based on U.S. population studies, approximately 5,600 people in the U.S. are diagnosed with ALS each year and as many as 25,000 Americans have the disease at any given time.

About Medical Research Counsel The United Kingdoms Medical Research Counsels mission is to improve human health through world-class medical research. To achieve this, MRC supports research across the biomedical spectrum, from fundamental lab-based science to clinical trials, and in all major disease areas. MRC works closely with the UKs National Health Service and the UK Health Departments to deliver its mission and give a high priority to research that is likely to make a real difference to clinical practice and the health of the population.

About the Sheffield Institute for Translational Neuroscience The Sheffield Institute for Translational Neuroscience (SITraN) is an international center of excellence recognized for its ground-breaking work in the fight against motor neurone disease and other common neurodegenerative disorders. SITraN brings together 300 staff and research students in multi-disciplinary teams with state-of-the-art laboratories and equipment to study neurological illness. The center is unique in its design to unite clinicians and multidisciplinary teams of scientists to translate discoveries in basic neuroscience into benefits for patients. The SITraN teams have developed a robust portfolio of in vitro and in vivo models to facilitate our understanding of disease mechanisms and identify new targets for therapeutic intervention which can be tested in our BRC experimental medicine programs.

The work of SITraN is a major pillar of the University of Sheffields cross-faculty Neuroscience Institute, one of four flagship research institutes launched in 2019 to tackle the biggest global challenges through pioneering real-world solutions and involving >120 principal investigators in the Faculties of Medicine, Science and Engineering.

About Aclipse Therapeutics Aclipse Therapeutics develops novel and differentiated drugs to treat orphan diseases with significant unmet medical needs. Our lead drug candidate, M102, is in development for the treatment of ALS with potential use in other neurodegenerative diseases such as Friedreichs ataxia, Huntington's disease and Parkinson's disease. M102 targets multiple disease pathomechanisms and enables a precision medicine approach for the identification of patients who are most likely to benefit from the drug. Aclipse has a very experienced orphan drug management team and a clinical advisory board of the top ALS physicians in the world. For more information about Aclipse, visit the website at https://www.aclipsetherapeutics.com or email info@aclipsetherapeutics.com.

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Aclipse Therapeutics Announces $2.2 Million Grant from UK's Medical Research Council for Development of M102 - BioSpace

MINNEAPOLIS, Jan. 28, 2021 (GLOBE NEWSWIRE) -- Predictive Oncology (NASDAQ: POAI), a knowledge-driven company focused on applying artificial intelligence (AI) to personalized medicine and drug discovery, announced today that its wholly owned subsidiary Soluble Biotech, Inc. just inked another contract with a large pharmaceutical company. The work will involve using Soluble Biotechs proprietary protein formulation technology to improve the solubility and stability of a protein therapeutic destined for future clinical use.

This opportunity may also lead to a long-term relationship whereby Soluble Biotech develops a strategic partnership to support several other therapeutics currently under development within the pharmaceutical company, said Dr. Larry DeLucas, Founder and President of Soluble Biotech, Inc.

About Predictive Oncology Inc.

Predictive Oncology (NASDAQ: POAI) operates through three segments (Skyline, Helomics and Soluble Biotech), which contain four subsidiaries: Helomics, TumorGenesis, Skyline Medical and Soluble Biotech.

Helomics applies artificial intelligence to its rich data gathered from patient tumors to both personalize cancer therapies for patients and drive the development of new targeted therapies in collaborations with pharmaceutical companies. TumorGenesis Inc. specializes in media that help cancer cells grow and retain their DNA/RNA and proteomic signatures, providing researchers with a tool to expand and study cancer cell types found in tumors of the blood and organ systems of all mammals, including humans. Skyline Medical markets its patented and FDA cleared STREAMWAY System, which automates the collection, measurement, and disposal of waste fluid, including blood, irrigation fluid and others, within a medical facility, through both domestic and international divisions. Soluble Biotech is a provider of soluble and stable formulations for proteins including vaccines, antibodies, large and small proteins, and protein complexes.

Forward-Looking Statements

Certain matters discussed in this release contain forward-looking statements. These forward-looking statements reflect our current expectations and projections about future events and are subject to substantial risks, uncertainties and assumptions about our operations and the investments we make. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue and financial performance, projected costs, prospects, plans and objectives of management are forward-looking statements. The words anticipate, believe, estimate, expect, intend, may, plan, would, target and similar expressions are intended to identify forward- looking statements, although not all forward-looking statements contain these identifying words. Our actual future performance may materially differ from that contemplated by the forward-looking statements as a result of a variety of factors including, among other things, factors discussed under the heading Risk Factors in our filings with the SEC. Except as expressly required by law, the Company disclaims any intent or obligation to update these forward-looking statements.

Investor Relations Contact:

Landon Capital Keith Pinder (404) 995-6671kpinder@landoncapital.net

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Soluble Biotech, a Wholly Owned Subsidiary of Predictive Oncology, Inked Contract with Large Pharmaceutical Company - GlobeNewswire

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH). Despite guideline recommendations for comprehensive genomic profiling (CGP) of all patients with advanced non-small cell lung cancer (NSCLC), profiling remains suboptimal due to continued reliance on invasive tissue biopsies for testing. A new study published in JCO Precision Oncology confirms previously reported data showing that the Guardant360 liquid biopsy is not only concordant to tissue genotyping, but detects significantly more informative alterations when used prior to tissue testing, and achieves similar treatment response rates and progression-free survival in patients with NSCLC. Publication link here.

The prospective study1 (n=186) compares comprehensive genomic profiling using the Guardant360 liquid biopsy versus standard-of-care tissue genotyping for first-line treatment decisions in advanced NSCLC. Patients with advanced NSCLC received targeted therapies based on the actionable biomarkers identified. Compared to tissue biopsy genotyping at time of diagnoses, the Guardant360 liquid biopsy was not only concordant with tissue biopsy but detected 23.6 percent more informative mutations when used first and before tissue biopsy.

The study adds to the growing body of evidence2-4 demonstrating that using a blood-first approach using the Guardant360 test for genomic biomarker detection can identify more actionable biomarkers than a tissue-first approach. Importantly, objective response rates and progression-free survival in biomarker-positive patients receiving targeted therapy was similar to previously reported registrational trials.

Despite the ever-growing availability of life-changing targeted drugs for treating patients with advanced lung cancer, many continue to be treated with chemotherapy or immunotherapy because first-line treatments are made without conducting comprehensive genotyping first, said the Principal Investigator of this study Dr. Rafael Rossell, Chief Medical Officer and President of the Dr. Rosell Oncology Institute. This publication outlines further evidence that the Guardant Health liquid biopsy is very effective in uncovering actionable genomic alterations, overcomes the challenges of tissue biopsies, and helps clinicians more easily customize treatments to improve the prognosis and survival of their patients.

Numerous clinical studies show that patients receiving targeted or personalized treatments have improved progression-free survival and higher overall response rates compared to chemotherapy or immunotherapy.5-11 Various factors contribute to clinical adoption of personalized medicine lagging behind recommended medical guidelines, including insufficient tissue for biopsy, which is the case for as many as 30 percent of solid cancer patients.12-14

Once again, the data show that our blood-first approach using our Guardant360 liquid biopsy has the advantage of increasing the number of patients receiving potentially life-changing targeted treatments without compromising treatment efficacy, said Helmy Eltoukhy, Guardant Health CEO. Sadly, research indicates that approximately 80 percent of advanced lung cancer patients do not receive comprehensive genotyping before starting treatment. I hope that with the recent FDA approval of our Guardant360 CDx liquid biopsy test, more clinicians will feel confident making the shift to liquid biopsies so we can reverse the serious trend of undergenotyping that exists today.

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360, Guardant360 CDx, and GuardantOMNI tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Healths liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Healths financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions Risk Factors and Managements Discussion and Analysis of Financial Condition and Results of Operation and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2019, in its Quarterly Reports on Form 10-Q for the periods ended March 31, 2020, June 30, 2020, and September 30, 2020, respectively, and in its other reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Healths views as of any date subsequent to the date of this press release.

References

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Head-to-Head Study Shows Guardant360 Liquid Biopsy Outperforms Tissue Biopsy for Comprehensive Genomic Profiling in Advanced Non-Small Cell Lung...

New York, Jan. 28, 2021 (GLOBE NEWSWIRE) -- The nutraceutical products market was valued at USD 270.96 Billion in the year 2019 and has been projected to rise at a CAGR of 7.1% from 2020 to 2027. Nutraceutical products are mainly a part of food that delivers several nutritional values to the diet. It is also considered as functional foods, containing pharmaceutical-grade and standardized nutrients. These supplements are the source of dietary supplements and work towards preventing diseases. People globally are becoming more inclined towards diverse food and beverage types, having added various nutritional supplements; thus, nutraceutical products are gaining traction.

Globally, various nutraceutical products are gaining immense popularity, becoming a part of the daily diet of consumers. The rising prevalence of various lifestyle diseases and the growing number of people taking numerous preventive healthcare measures are stimulating demand in the industry. Increasing utilization of a wide range of functional food and beverages by the young population is further augmenting the markets growth over the estimated era. High technological progress in the area of nutraceutical products is also contributing to the industrys development. A trend of personalized medicine is likely to trigger demand for nutraceutical products.Get FREE Sample Copy with TOC of the Report to understand the structure of the complete report@ https://www.reportsanddata.com/sample-enquiry-form/2421

The market for nutraceutical products is primarily fueled by factors such as rising awareness about health among the aging population, increasing costs of health care, diet-disease links, and fast advancements in nutrition and food technology. Currently, various health concerns, including cardiovascular disease, cholesterol reduction, and osteoporosis, are attractive targets for a range of nutraceutical products, followed by high blood pressure, menopause-related ailments, child development, diabetes, GI disorders, and lactose intolerance.

Further key findings from the report suggest

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Segments covered in the report:

This report forecasts revenue growth at global, regional & country levels, and provides an analysis of market trends in each segment and sub-segment from 2017 to 2027. For the purpose of this study, Reports and Data has segmented the nutraceutical products market on the basis of source, product, distribution channel, and region:

Source Outlook (Revenue, USD Million; 2017-2027)

Product Outlook (Revenue, USD Million; 2017-2027)

Distribution Channel Outlook (Revenue, USD Million; 2017-2027)

Click on the link to read key highlights of the report and look at projected trends for years to come: https://www.reportsanddata.com/report-detail/nutraceutical-products-market

Regional Outlook (Revenue, USD Million; 2017-2027)

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Personalized Nutrition Market Size, Share & Analysis, By Type (Nutrition, Active Measurement Tools, Services), By Application (General Health, Medical, Sports), And By Channel (Direct-to-Consumer, Wellness & Fitness Centers, Hospitals & Clinics), Forecasts To 2027

Digestive Health Products Market Size, Share & Analysis, By Ingredient (Prebiotics, Probiotics, Digestive Enzymes), By Product (Non-Alcoholic Beverages, Bakery & Cereals, Dairy), By Distribution Channel (Modern Trade, Convenience Stores, And Online Retailers) And Region, Forecast To 2027

Resistant Maltodextrin Market Size, Growth Trends & Analysis By Type (Corn-Based, Wheat-Based, Potato-Based, Others), By Application (Beverages, Bakery & Confectionery, Dairy Products, Nutraceuticals, Others), By Region, Forecast To 2027

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Nutraceutical Products Market Size To Reach USD 461.70 Bn By 2027 | Growing Demand for Fortified Food Owing to the Increasing Health Consciousness...

DALLAS--(BUSINESS WIRE)--Perspectum announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Hepatica, a precision oncology decision support tool for liver cancer.

Each year, around 200,000 Americans are diagnosed with primary or secondary liver cancer, with surgery as one of the key treatment options. The success of surgery relies on the volume and health of the remaining liver, which is impacted by any underlying chronic liver disease (CLD). Fatty liver disease, chronic viral hepatitis B and C as well as alcoholic liver disease affect nearly 100 million Americans, with prevalence increasing. Accurate pre-surgical assessment of liver health is therefore urgently needed to improve the outcomes for patients.

Hepatica uses non-invasive quantitative multiparametric MRI to provide a liver health assessment based on AI-driven liver segmentation together with proprietary biomarkers for hepatic fibro-inflammation and fat. Using AI to delineate the liver and calculate regional volumes saves over 20 minutes of pre-operative radiology time per case.

Initial results from UK-based study on 143 surgical candidates showed that by combining estimated future liver remnant with an assessment of underlying fibro-inflammation, Hepatica could effectively identify patients at risk of poor outcomes from surgery and a longer stay in hospital. This information enables tumour boards and multidisciplinary teams to make more informed pre-operative decisions to improve post-operative outcomes for patients, translating to cost-savings in associated care.

Mr Myrddin Rees, Consultant General and Hepatobiliary Surgeon at HHFT commented, As a hepato-biliary surgeon with over 30 years of experience operating on the liver I am thrilled that Hepatica is now cleared for clinical use. The missing element in all our current diagnostic, non-invasive imaging is an accurate assessment of the quality of the liver parenchyma. Hepatica provides the surgeon with a measure of liver well-being that allows us to push the boundaries on the one hand whilst avoiding the removal of inappropriate liver volume on the other. This work is a significant advance in our quest to treat more patients with liver disease whilst armed with the knowledge of what can be achieved safely.

Hepatica seamlessly integrates into the clinical workflow and provides a simple, patient-friendly report via a cloud-based service.

Hepatica is an advanced oncology tool that provides objective information to guide personalized clinical management, said Professor Claude Sirlin, Professor of Radiology at University of California, San Diego. It is an excellent application of smart imaging and Artificial Intelligence in medicine, and I look forward to seeing how it can be used in a variety of indications to improve clinical care.

Notes to Editors

About Hepatica

Hepatica is a precision oncology tool for clinical and surgical decision support tool based on non-invasive quantitative multiparametric MRI. It identifies high risk patients and enables more informed preoperative decision making, therefore improving post-operative outcomes. Hepatica has demonstrated utility in identifying patients at risk of poor outcomes, with the potential to inform surgical planning and realize significant cost savings through lowering the post-surgical complication rate, associated in-patient hospital stay and reducing time required from radiologists.

About Perspectum

Perspectum delivers cutting-edge digital technologies that help clinicians provide better care for patients with liver disease, diabetes and cancer. With a strong focus on precision medicine using advanced imaging and genetics, our vision is to empower patients and clinicians through quantitative assessments of health enabling early detection, diagnosis, and targeted treatment. With a diverse team of physicians, biomedical scientists, engineers and technologists, Perspectum offers a way to manage complex health problems at scale. For more information, visit perspectum.com.

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FDA Clearance for Hepatica, Perspectum's Surgical Decision Support Tool for Liver Cancer - Business Wire