MEDTECH

QIAGEN Launches Syndromic Test for QIAstat-Dx Device to Combat Global Monkeypox Health Emergency

QIAGEN | August 16, 2022 | Read time : 03:00 min

QIAGEN Launches
QIAGEN N.V. announced the launch of the QIAstat-Dx Viral Vesicular Panel RUO, the first syndromic test to differentiate between monkeypox and five other pathogens which cause similar symptoms.

The new panel ­– currently for research use only comes in cartridge form to run on QIAGEN’s QIAstat-Dx automated syndromic testing devices. It tests for the two known forms of monkeypox virus herpes simplex virus 1 HSV2, human herpesvirus 6 (HH6), varicella-zoster virus and enterovirus – pathogens that all produce similar-looking vesicular lesions.

With some 3,000 QIAstat-Dx PCR devices installed in specialized laboratories around the world, QIAGEN is leveraging the value of syndromic testing proven during the pandemic to help fight the spread of monkeypox, recently declared a public health emergency by the World Health Organization and the US government.

Monkeypox cases are soaring across the globe with many demographic groups infected. Surveillance is an essential tool in the fight against infectious diseases. QIAstat-Dx Viral Vesicular Panel in combination with the QIAstat-Dx platform will allow medical researchers to detect monkeypox with gold-standard PCR testing-technology in about one hour. Currently the world’s only syndromic test for the pathogen, the panel will prove to be crucial for detecting and then combatting the spread of monkeypox around the globe.”

Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN

The panel’s RUO-status means it currently can only be used for the surveillance – not screening or diagnosing – of monkeypox cases. But QIAGEN is ready to make applications for clinical use should authorities in the United States and the European Union open new diagnostic pathways in light of this public-health emergency.

QIAGEN teams around the world are working with healthcare authorities to support testing for the monkeypox virus outbreak. The QIAstat syndromic testing solution adds to the broad portfolio that the company offers to address all testing needs. Alongside QIAGEN sample-technology kits, testing components and instruments that are used for instance by public health agencies for the development of their own tests, the NeuMoDx clinical PCR system allows laboratories to process self-developed tests (LDTs). A commercial single-plex assay running on this instrument is currently in development. The QIAcuity digital PCR also allows for monkeypox detection in wastewater – a surveillance method that proved its worth during the COVID-19 crisis.

The concept of syndromic testing has shown its value during the pandemic, when QIAGEN launched the QIAstat-Dx Respiratory SARS-CoV-2 panel to differentiate between up to 23 viral and bacterial targets for common pathogens causing respiratory tract infections. The company also introduced the high-throughput QIAstat-Dx Rise device that processes up 160 tests per day. QIAGEN has extended syndromic testing to other areas, including gastrointestinal conditions and meningitis.

About QIAGEN
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics and Life Sciences . As of June 30, 2022, QIAGEN employed more than 6,100 people in over 35 locations worldwide.

Spotlight

Genetic engineering: Techniques to alter the chemistry of genetic material (DNA and RNA), to introduce these into host organisms and thus change the phenotype of the host organism.


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MEDTECH

AMPEL BioSolutions' Precision Medicine Breakthrough Predicts Drug Options with RNA Analytics & Machine Learning

AMPEL BioSolutions | July 07, 2022

AMPEL BioSolutions announces a breakthrough in precision and personalized medicine that could modernize the way doctors treat patients across a wide variety of diseases including autoimmunity, infectious disease and cancer. Revealed at the Precision Medicine World Conference in Silicon Valley California, the first-in-class platform technology utilizes RNA analytics and machine learning to characterize an individual's gene expression and provide clinical decision support to physicians for treatment options for their patients. The technology, only a concept for the last few years, is being utilized to launch a portfolio of 10+ clinical tests over the next five years to provide decision support for diseases that affect more than 50 million Americans. AMPEL's innovative machine learning approach, which is now ready to be developed as a clinical decision support biomarker test, could greatly impact health care by allowing physicians to identify the cause of patient disease symptoms and select appropriate treatment more precisely. AMPEL's approach is sufficiently sensitive to detect early signs of disease and group patients by the severity of their condition. The application of AMPEL's technology is already assisting 15+ pharmaceutical companies in drug development and clinical trials. Patients with autoimmune and inflammatory diseases often suffer from unpredictable disease activity that impacts daily activities like work and family life. Since unpredictable symptoms often result in trips to the Emergency Room, the ability to predict worsening disease and systemic involvement with routine testing has important health care and health economics implications. AMPEL expects to bring it's first two products to market in the next few years, LuGENE® blood test for Lupus and DermaGENE® skin biopsy test for Psoriasis, Atopic Dermatitis, Scleroderma and Lupus. In addition, AMPEL's CovGENE® blood test that predicts how severe a disease course a COVID patient may experience and may be applicable to "long COVID" is ready for licensing/co-development with a company already offering COVID diagnostic testing. Paired with AMPEL's pipeline of tools to analyze very large and complex clinical datasets ("Big Data"), AMPEL's Genomic Platform technology with machine learning is a significant step towards implementing routine testing to monitor disease activity and provide decision support for treatment based on a patient's gene expression. This will transform the way doctors treat patients by using the information gathered by the lab test and analyzed by machine learning to diagnose, characterize the precise molecular abnormalities and treat diseases before damage begins, saving patients from pain and inconvenience of diseases that otherwise drastically affect their lives. Pharmaceutical companies test drugs in clinical trials and face the challenge of enrolling patients that have the best potential to respond to the treatment being tested. Enrolling the "wrong" patients can result in trial failure, often leading to cancellation of a drug's development towards FDA approval that may have benefit in a sub-group of the overall patient population. AMPEL's technology helps pharmaceutical companies proactively identify the patients most likely to respond to specific treatments, thereby helping improve outcomes in clinical trials and quality of life for patients in need. AMPEL's Pharma work was highlighted by Dr. Peter Lipsky at the Precision Medicine World Conference in a panel discussing the use of machine learning in clinical trial patient selection and outcome prediction and by Dr. Amrie Grammer at a Google-Reuters webinar focused on machine learning approaches to select the right patient for the right trial at the right time. "It is very gratifying to see a concept develop into a reality that can help patients. When we began some years ago we thought that analyzing gene expression data could subset patients effectively and allow the molecular profile of each patient to be used to help identify the best treatment for each individual. By applying novel machine learning approaches, we are now ready to launch our first application that we believe should be a major step toward providing patients with autoimmune diseases true precision medicine." Dr. Peter Lipsky, AMPEL Co-Founder, CEO and Chief Medical Officer Dr. Amrie Grammer, AMPEL Co-Founder, President and CSO: ""Our team has developed a genomic platform technology with machine learning that supports clinical precision medicine tests that predict drug options based on gene expression. AMPEL is changing the paradigm of treatment in autoimmune and inflammatory diseases. We are proud to be doing this work in Virginia and will continue to recruit talent and grow our business here." Many chronic diseases have unexpected flares that dramatically affect patient quality of life. Further, treatments for chronic disease have been developed based on a patient population as a group, so some individuals will respond differently or not at all to available treatments. For the past nine years, the scientists and clinicians at AMPEL have been working on ways to address this problem, by designing concepts to personalize treatments for an individual patient as opposed to a patient population. Peer reviewed publications confirm the practicality of AMPEL's concept, which are now in the commercialization phase. AMPEL's initial focus was lupus but the test can be used for many autoimmune or inflammatory diseases. AMPEL's blood and tissue biopsy tests are prognostic and staging biomarkers that will provide decision support for their physician with the most appropriate drugs for the patient at that moment in time. About AMPEL BioSolutions LLC AMPEL BioSolutions is a precision medicine company commercializing a development pipeline of CLIA-certified gene expression tests for blood or tissue samples that provide clinical decision support by determining disease status, identifying molecular pathway and predicting drug options. AMPEL's technology is a cloud-based platform that hosts proprietary RNA analytic tools and machine learning algorithms covered by 25+ filed/pending patents and 80+ peer-reviewed publications in high impact journals. Disease Areas for AMPEL's precision medicine test portfolio include Systemic Lupus Erythematosus, Psoriasis, Scleroderma, Atopic Dermatitis, Lupus Nephritis, Fibromyalgia, Cardiovascular, Sjogren's Syndrome, ASD, Wellness, Lung Cancer and SARS-Cov2. AMPEL's technology covers over 95% of all known genes and AMPEL's exclusive curated database of >15,000 individual gene expression profiles with rich clinical information fuels machine learning predictions based on evidence. AMPEL BioSolutions was elected to the Coalition for 21st Century Precision Medicine in early 2022.

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INDUSTRIAL IMPACT

Akili Announces Public Company Board of Director Nominees

Akili Interactive | July 11, 2022

Akili Interactive a leading digital medicine company pioneering the development of cognitive treatments through game-changing technologies, announced the nominees for its future board of directors, effective upon the closing of Akili’s business combination with Social Capital Suvretta Holdings Corp. I subject to customary closing conditions. Shares of the new public company’s common stock are expected to trade on Nasdaq under the symbol “AKLI.” Akili’s public company board of directors is expected to consist of seven directors, with several new and recent additions, including William (BJ) Jones, Chief Commercial Officer of Biohaven Pharmaceuticals; Christine Lemke, Co-Chief Executive Officer of Evidation Health; Ken Ehlert, former Chief Scientific Officer at UnitedHealth Group; and Chamath Palihapitiya, founder and CEO of Social Capital and Chairman and Managing Partner of SCS. Nominees also include existing Akili directors Bharatt Chowrira, Ph.D., J.D., Adam Gazzaley, M.D., Ph.D. and Eddie Martucci, Ph.D. These director nominees bring industry leadership and deep expertise in access and reimbursement, innovative go-to-market approaches and groundbreaking research that will guide Akili as the company enters its next phase of growth to commercialize digital therapeutics at scale. “Akili is creating a new class of medicine that has the potential to fundamentally change how we think about cognitive health. As we forge this new path, it’s important to have a broad range of expertise, from pioneering leading-edge science to navigating our healthcare system to establishing new standards of patient care. The board and I look forward to supporting Eddie and his team as they bring their first product to market, and hopefully many more breakthrough therapeutics in the coming years.” Chamath Palihapitiya, incoming chair of Akili’s board of directors Eddie Martucci, co-founder and Chief Executive Officer of Akili, added: “We look forward to becoming a publicly-traded company through our merger with SCS and we are proud to nominate this impressive slate of life sciences and technology leaders to constitute Akili’s new public board and help guide our corporate and clinical strategy.” Board Member Biographies Chamath Palihapitiya founded Social Capital in 2011 and has been its Managing Partner since its inception. Mr. Palihapitiya also serves as the Chief Executive Officer and the Chairman of the board of directors of DNAB, DNAC and DNAD. In addition, Mr. Palihapitiya currently serves as the Chief Executive Officer and the Chairman of the board of directors of each of Social Capital Hedosophia Holdings Corp. IV and Social Capital Hedosophia Holdings Corp. VI. Mr. Palihapitiya previously served as the Chief Executive Officer and the Chairman of the board of directors of Social Capital Hedosophia Holdings Corp. from May 2017 until the consummation of its business combination with Virgin Galactic in October 2019, and served as the Chairman of the board of directors of Virgin Galactic until February 2022. Mr. Palihapitiya also previously served as the Chief Executive Officer and the Chairman of the board of directors of Social Capital Hedosophia Holdings Corp. II until the consummation of its business combination with Opendoor Labs Inc. in December 2020 and as the Chief Executive Officer and the Chairman of the board of directors of Social Capital Hedosophia Holdings Corp. III until the consummation of its business combination with Clover Health Investments, Corp. in January 2021 and as the Chief Executive Officer and Chairman of the board of directors of Social Capital Hedosophia Holdings Corp. V until the consummation of its business combination with Social Finance, Inc. in May 2021. Mr. Palihapitiya also served as a director of Slack Technologies Inc. from April 2014 until October 2019. Prior to founding Social Capital in 2011, Mr. Palihapitiya served as Vice President of User Growth at Facebook, and is recognized as having been a major force in its launch and growth. Mr. Palihapitiya was responsible for overseeing Monetization Products and Facebook Platform. Prior to working for Facebook, Mr. Palihapitiya was a principal at the Mayfield Fund, one of the United States’ oldest venture firms, before which he headed the instant messaging division at AOL. Mr. Palihapitiya graduated from the University of Waterloo, Canada with a degree in electrical engineering. William Jones, Jr. has served as Chief Commercial Officer of Biohaven Pharmaceuticals Holding Company Ltd., a publicly traded biopharmaceutical company, where he has been responsible for building the company’s commercial capability and launching their first FDA-approved product (Nurtec ODT), since April 2019. Prior to Biohaven, from January 2016 to March 2019, Mr. Jones served as Vice President, Head of Sales and Commercial Operations for the general medicine business unit of Takeda Pharmaceutical Company Limited, a publicly traded pharmaceutical company. Mr. Jones holds a B.S. in human factors engineering from the United States Air Force Academy, an M.S. in industrial engineering from Texas A&M University and an MBA from the Stanford University Graduate School of Business. Christine Lemke has served as a member of Akili’s board of directors since September 2021. Since March 2012, Ms. Lemke has been employed by Evidation Health, Inc., a real-world health measurement and engagement platform, where she currently serves as Co-Chief Executive Officer and Director. Since February 2016, she has also served as co-founder and General Partner of Ensemble Labs, GP, an investor in early stage health technology companies. Prior to Evidation Health and Ensemble Labs, Ms. Lemke was co-founder and Chief Operating Officer of Sense Networks, Inc., developers of the first machine learning platform for mobile phone activity data. Ms. Lemke holds a B.A. in business from the University of Washington and an MBA from HEC Paris. Kenneth Ehlert has served as a member of Akili’s board of directors since December 2021. Previously, he held senior leadership positions at UnitedHealth Group, a publicly traded managed healthcare and insurance company, including most recently as Chief Scientific Officer from December 2017 to July 2021. From January 2009 until December 2017, Mr. Ehlert served as Chief Executive Officer of Savvysherpa Inc., a research and development firm. Mr. Ehlert holds a B.A. in economics and mathematics from Brigham Young University and an M.S. in applied economics from the University of Minnesota. Bharatt Chowrira, Ph.D., J.D., has served as a member of Akili’s board of directors since June 2021 and previously served as a member of Akili’s board of directors from November 2017 until September 2019. Since February 2017, Dr. Chowrira has served as President and as a member of the board of directors of PureTech Health plc. Prior to joining PureTech Health, Dr. Chowrira served as President of Synlogic, Inc., a biopharmaceutical company focused on developing synthetic microbiome-based therapeutics. Dr. Chowrira also previously served as Chief Operating Officer of Auspex Pharmaceuticals Inc., a biotechnology company, and as President and Chief Executive Officer of Addex Therapeutics Ltd., a biotechnology company. Prior to that, Dr. Chowrira held various leadership roles at Nektar Therapeutics, Merck & Co., Sirna Therapeutics and Ribozyme Pharmaceuticals. Since September 2018, Dr. Chowrira has also served as a member of the board of directors of Vedanta Biosciences, Inc., a clinical stage company. He was previously on the boards of Vor Biopharma, Inc., a publicly-traded cell and genome engineering company, between August 2018 and June 2020, and Karuna Therapeutics, Inc., a publicly-traded biopharmaceutical company, from August 2017 to December 2019. Dr. Chowrira received a J.D. from the University of Denver’s Sturm College of Law, a Ph.D. in molecular biology from the University of Vermont College of Medicine, an M.S. in molecular biology from Illinois State University and a B.S. in microbiology from the UAS, Bangalore, India. Adam Gazzaley, M.D., Ph.D., one of Akili’s co-founders, has served as a member of Akili’s board of directors since November 2014 and as Chief Science Advisor since January 2011. Dr. Gazzaley is the David Dolby Distinguished Professor of Neurology, Physiology and Psychiatry at the University of California, San Francisco (“UCSF”), and the Founder & Executive Director of Neuroscape at UCSF, where he has been employed since July 2005. Additionally, Dr. Gazzaley is co-founder and Chief Scientific Advisor of JAZZ Venture Partners LLC, a venture capital firm focused on technologies that improve human performance. Dr. Gazzaley has also been on the Board of Trustees of the California Academy of Sciences since May 2019, a Science Council Member there since August 2019, and a Science Fellow there since May 2020. From January 2015 to January 2018, he served as a Science Board member of the President’s Council on Fitness, Sports & Nutrition. Dr. Gazzaley holds a B.S. in biochemistry from Binghamton University, and a Ph.D. in neuroscience and an M.D. from Mount Sinai School of Medicine. He completed his postdoctoral fellowship in neuroscience at Mount Sinai School of Medicine and his residency in neurology at the hospital of the University of Pennsylvania. W. Edward Martucci, Ph.D., one of Akili’s co-founders, has served as Akili’s Chief Executive Officer and as a member of Akili’s board of directors since August 2015, including as Akili’s employee beginning in September 2017. From June 2009 to September 2017, Dr. Martucci was employed by PureTech Health PLC, a publicly traded biotherapeutics company, where he co-founded Akili in 2011 and served as Akili’s Chief Operating Officer from 2011 until August 2015. Since February 2017, he has served on the board of the Digital Therapeutics Alliance, a digital therapeutics industry advocacy organization. Dr. Martucci holds a B.S. in biochemistry from Providence College and a M.Phil. and Ph.D. in molecular biophysics and biochemistry from Yale University. About Akili Akili is pioneering the development of cognitive treatments through game-changing technologies. Our approach of leveraging technologies designed to directly target the brain establishes a new category of medicine – medicine that is validated through clinical trials like a drug or medical device but experienced like entertainment. Akili’s platform is powered by proprietary therapeutic engines designed to target cognitive impairment at its source in the brain, informed by decades of research and validated through rigorous clinical programs. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s products are delivered through captivating action video game experiences.

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MEDICAL

Salipro Biotech Obtains Granted Patents in the United States and China for Direct Extraction of Membrane Proteins and Library Generation

Salipro Biotech | September 08, 2022

Salipro Biotech AB, a Swedish biotech company with a leading technology platform for the stabilization of membrane proteins for drug development, announced today that its patent entitled "Saposin lipoprotein particles and libraries from crude membranes" has been issued by both the U.S. Patent and Trademark Office and by the China National Intellectual Property Administration. The patents cover the company's novel method of direct extraction of membrane proteins from cells or crude membranes to enable drug development for challenging drug targets, as well as the generation of Salipro libraries representing the membrane proteome, the particles themselves and their use in drug discovery and membrane protein research, amongst others. The Salipro® technology enables the development of novel therapeutics against drug targets that previously could not be investigated. The award of these patents further strengthens Salipro Biotech's global intellectual property portfolio, with various patents already granted i.a. in the U.S., EU, China and Japan. "We are excited to announce the granting of these patents in the U.S. and in China. This news represents an important corporate achievement that fosters our position to accelerate drug discovery programs with pharma companies on challenging drug targets. Jens Frauenfeld, CEO Maria Knudsen, Business Development Director, comments: "DirectMX® is already being implemented in our partnered drug discovery programs for a range of drug targets, including GPCRs, SLCs and Ion Channels. The addition of these patents to our IP portfolio further solidifies Salipro Biotech's position as a holder of a key drug discovery platform and will enable us to increase the value of our pharma collaborations as well as continue to build our internal pipeline." About Salipro Biotech AB Salipro Biotech AB is a privately held biotech company focused on unlocking challenging drug targets for the development of next-generation therapeutics. The company is headquartered in Stockholm, Sweden with a fully owned IP portfolio that covers the Salipro® platform technology. To date, Salipro Biotech has signed multiple research collaborations with top-tier pharma and biotech companies.

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CELL AND GENE THERAPY

Antibe Academic Collaborator to Present Clinical Data at PAINWeek 2022

Antibe Therapeutics Inc. | September 07, 2022

Antibe Therapeutics Inc. a clinical-stage company leveraging its hydrogen sulfide platform to develop next-generation safer therapies that target inflammation, is pleased to announce the selection of a poster presentation of clinical data supporting otenaproxesul’s acute pain efficacy, to be delivered at the PAINWeek National Conference taking place on September 6 - 9 in Las Vegas. The poster will be presented by the lead author of the study and Antibe academic collaborator, James R.W. Glanville, MBChB, MRCP, a UK-based rheumatologist with an academic affiliation to University College London. “I’m delighted to have the opportunity to share our clinical data at PAINWeek. As our poster details, the study showed otenaproxesul’s remarkable potency in reducing pain and inflammation. Of particular interest was otenaproxesul’s ability to reduce white blood cell infiltration. Given the ongoing opioid crisis, it is imperative that we find novel, efficacious therapeutics that limit adverse effects and risk. As a physician focused on treating inflammatory conditions, I appreciate the potential of otenaproxesul as a GI-sparing alternative to traditional NSAIDs.” Dr. Glanville The poster reflects results originally published in a peer-reviewed research paper in The FASEB Journal (Federation of American Societies for Experimental Biology) available at faseb.onlinelibrary.wiley.com/doi/abs/10.1096/fj.201902918RR. Utilizing a novel experimental model of human inflammation, the 2019 study involved 21 healthy male volunteers randomly assigned into one of three treatment arms, including a no-treatment control group. The poster will be available in the Scientific Publications section of the Company’s website following the presentation. Dr. Joseph Stauffer, Antibe’s Chief Medical Officer, remarked, “We appreciate the pioneering work that Dr. Glanville and his colleagues have done to elucidate otenaproxesul’s acute pain efficacy in humans. With its Phase II acute pain program initiating this month, we are excited to have the drug’s first acute pain results presented to practitioners at a major conference.” Held annually, the PAINWeek National Conference is the largest U.S. conference for frontline healthcare professionals with an interest in pain management. About Antibe Therapeutics Inc. Antibe is a clinical stage biotechnology company leveraging its proprietary hydrogen sulfide platform to develop next-generation safer therapies to target inflammation arising from a wide range of medical conditions. The Company’s current pipeline includes assets that seek to overcome the gastrointestinal ulcers and bleeding associated with nonsteroidal anti-inflammatory drugs. Antibe’s lead drug, otenaproxesul, is in clinical development as a safer alternative to opioids and today’s NSAIDs for acute pain. Antibe’s second pipeline drug, ATB-352, is being developed for a specialized pain indication. The Company’s anticipated next target is inflammatory bowel disease a condition long in need of safer, more effective therapies.

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