Seattle-based Adaptive Biotechnologies Corp. said it has begun enrolling a virtual clinical study, ImmuneRACE, as part of a broader effort it has undertaken with Redmond, Wash.-based Microsoft Corp. to rapidly map and measure the immune response to the COVID-19 virus to inform improved diagnostics to fulfill the need for more reliable testing. The study calls for 1,000 participants in select U.S. metropolitan areas impacted by COVID-19. De-identified data will be made freely available to public health officials, academia and industry to help accelerate solutions to the pandemic. Laboratory Corporation of America Holdings (Labcorp), of Burlington, NC, through its Covance drug development business, will manage the collection of blood samples and nose/throat swabs from participants from their homes. As part of the study, the partners will measure the presence of specialized cells of the immune system in the blood, called T cells, that identify the disease early on and proliferate to combat the infection. Together, Adaptive and Microsoft are mapping and measuring the immune response of T cells specific to many diseases and are now applying their combined capabilities to COVID-19.
Pittsburgh-based Alung Technologies Inc., a provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, reported the recent initiation of commercial development of its next generation artificial lung, which expands the company’s focus on highly efficient gas exchange devices and also broadens its applicable market. The next generation Hemolung Ras is based upon intellectual property recently licensed to Alung from the University of Pittsburgh. This new technology platform significantly enhances gas exchange efficiency while reducing the deleterious hematologic effects from extracorporeal blood circulation. Currently, the Hemolung Ras has the CE mark. The device was recently granted emergency use authorization by the U.S. FDA for the treatment of acute respiratory failure caused by COVID-19.
Stony Brook, N.Y.-based Applied DNA Sciences Inc. applied prior to the end of April for U.S. FDA emergency use authorization (EUA) for its Linea COVID-19 diagnostic candidate to detect SARS-CoV-2, the novel coronavirus that causes the disease COVID-19. Validation for the EUA was completed in collaboration with Stony Brook University Hospital; the company’s neighbor and collaborator on campus. The assay is designed to be run in high-throughput workflows that enable same-day results to be transmitted to the ordering physician. In a spirit of continuous innovation and improvement of the end-to-end process of patient diagnosis, the company is investigating methods to enhance the assay to increase the ease of patient sampling by using saliva instead of invasive nasopharyngeal swabbing methods.
Cleveland-based Athersys Inc. reported that the first patients have been enrolled in Athersys’ pivotal Phase 2/3 study titled, Multistem Administration for COVID-19 Induced Acute Respiratory Distress Syndrome (MACOVIA). The patients were enrolled at University Hospital’s Cleveland Medical Center (UH Cleveland). Medpace, a contract research organization (CRO) based in Cincinnati, is serving as the CRO for this study. This study is designed to enroll approximately 400 subjects. The first patients were enrolled into the first cohort of the study, which is an open-label, single active treatment arm to evaluate the safety of Multistem administered at two dose levels to study subjects with moderate to severe ARDS associated with COVID-19. If the treatment is well tolerated in this first cohort, the study is designed to further evaluate Multistem efficacy, safety and tolerability in this patient population using a robustly powered, double-blind, randomized and placebo-controlled trial protocol. The primary efficacy endpoint for the MACOVIA study will compare the number of ventilator-free days through day 28 among Multistem and placebo treatment groups. Secondary objectives of the study are to evaluate 60-day all-cause mortality, time in the intensive care unit, pulmonary function, tolerability and quality of life among survivors through one-year of follow-up.
Philadelphia-based Avidium Labs, in partnership with Nxt Group, has introduced a rapid IgG/IgM antibody test kit for SARS-CoV-2. The test kit has been validated at the company's international partner facility and with U.S.-based laboratories in New York and California.
Bayer AG, of Leverkusen, Germany, reported the launch of Test4TRK program in collaboration with Fort Myers, Fla.-based Neogenomics Inc. to offer genomic cancer testing for NTRK gene fusions at no cost for patients with RAI-refractory (RAI-R) differentiated thyroid carcinoma (DTC) and metastatic colorectal cancer (mCRC) with high microsatellite instability (MSI-H). NTRK gene fusions, which have been shown to drive tumor growth, are more commonly found in patients with MSI-H mCRC and RAI-R DTC and may play a role in disease management. Bayer will cover the full cost of the test regardless of the results, treatment decision and patient’s insurance coverage. All eligible patients who enroll and opt-in to the program will receive an RNA-based next-generation sequencing (NGS) test, NTRK NGS Fusion Profile. Patients with an adequate tissue sample will also receive a Pan-Tropomyosin receptor kinase (Pan-TRK) Immunohistochemistry (IHC) test.
In the wake of the COVID-19 pandemic, Angel Porgador, from the department of microbiology, immunology and genetics at Israel’s Ben-Gurion University (BGU) and the National Institute of Biotechnology in the Negev, and Mark Schvartzman, of the department of materials engineering at BGU, are developing novel surface coatings that contain nanoparticles of safe metal ions and polymers with antiviral and antimicrobial activity.
Biocardia Inc., of San Carlos, Calif., reported data from a recent animal study performed it said demonstrated meaningful improvements in heart function for subjects treated with its allogenic neurokinin 1 receptor positive mesenchymal stem cell (NK1R+ MSC) program for heart failure, known as Cardiallo. The company also is planning additional exploration and discussion with the U.S. FDA on the use of its allogenic cells for COVID-19-related acute respiratory distress syndrome. In the 26 animals treated with both low- and high-dose NK1R+ MSC, echocardiographic measures of cardiac ejection fraction, fractional shortening and cardiac outflow were meaningfully improved, with all three measures being statistically significant for both dosage levels over control animals.
Eleven projects have been chosen to participate in the 3rd edition of Craash Barcelona, the acceleration program Biocat organizes in collaboration with Boston’s Consortia for Improving Medicine with Innovation and Technology, a health accelerator, and EIT Health, a European health consortium.
Caredx Inc., of Brisbane, Calif., reported a strategic alliance with Weill Cornell Medicine that makes Caredx the exclusive development and commercialization partner of Uromap, a urine-based gene-expression test for acute cellular rejection in kidney transplant recipients.
Cycle Pharmaceuticals Ltd., of Cambridge, U.K., and Coventry, U.K.-based Medherant Ltd. signed an agreement to develop and commercialize multiple products using the Tepi Patch technology.
Invicro LLC, a Boston-based Konica Minolta company, is working with Microsoft Corp., of Redmond, Wash., to create a free repository of COVID-19 diagnostic computed tomography and X-ray datasets to facilitate understanding and treating this global threat.
Lowell, Mass.-based Launchpad Medical Inc. won a $2.5 million direct-to-phase II Small Business Innovation Research grant from the National Institute of Neurological Disorders and Stroke to advance the development of Tetranite, its bone adhesive biomaterial technology, to improve cranial flap fixation procedures. The clinical use of this product is expected to enhance bone healing, reduce infection rates and improve the cosmetic outcome of these procedures for patients while eliminating the need for metal fixation hardware.
New York-based Oberland Capital Management LLC announced the closing of the Oberland Capital Healthcare Solutions Fund and affiliated funds, with $1.05 billion of capital commitments at the fund's hard cap. The Solutions Fund will provide capital to biopharmaceutical, diagnostic and medical device companies.
Proteus Digital Health Inc., of Redwood City, Calif., reported a multiyear, outcomes-based initiative with the state of Tennessee’s Medicaid program, Tenncare. This collaboration aims to support Tenncare-covered patients undergoing hepatitis C treatment to achieve a cure through improved medication adherence and stronger connections to care teams. Under the terms of this contract, Proteus will only receive payment from TennCare if a patient on digital medicine therapy successfully completes treatment and is cured. There is no additional cost to patients or providers.
San Diego-based Resmed launched cloud-based remote monitoring software for ventilators and Lumis bilevel devices across Europe, via its Airview platform.
Safeguard Medical, of Harrisburg, NC, acquired Water-Jel Technologies, of Carlstadt, N.J., which focuses on emergency burn care products. Financial terms of the transaction are not being disclosed.
Sg Blocks Inc., of New York, and Osang Healthcare Co. Ltd., of Anyang, South Korea, reported the signing of a one-year, non-exclusive distributorship agreement for the U.S., for the latter’s Genefinder COVID-19 Plus Realamp Kit. Designed to detect SARS-CoV-2 through a gene-based real-time RT-PCR process, the testing kit received emergency use authorization from the U.S. FDA in mid-April.
Health Canada is restricting the use of a made-in-Canada, rapid COVID-19 test developed by Ottawa-based Spartan Bioscience Inc. following concerns about the efficacy of the product’s swabs. The company has shipped out 5,500 Spartan Cube test nationally, but said it is voluntarily recalling the product to perform more clinical tests. Spartan had touted on-site results of less than 60 minutes using the kit, but said Ottawa is limiting its use to research purposes until adequate evidence of clinical performance can be provided.
Stoltz One LLC, of Atlanta, said it has partnered with the CDC Foundation to import and supply personal protective equipment for health care workers in the U.S.
Branford, Conn.-based Tangen Biosciences Inc. said the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) has awarded it the second option of a contract to develop a molecular diagnostic platform that can be used by the company to rapidly develop infectious disease tests. With BARDA’s support, Tangen delivered the milestones set from the first option and is now entering the second – to conduct a clinical trial for a bloodstream Anthrax diagnostic using the fully developed and integrated Tangendx platform. Tangen intends to submit a 510(k) premarket notification to FDA for the TangenDx – Anthrax assay and Tangen’s Genespark instrument before the end of the year.
Thinklabs Medical LLC, of Centennial, Colo., launched Safe Distance Auscultation for its One digital stethoscope. Doctors can listen to patients' hearts and lungs while wearing personal protective equipment (PPE) or from a safe distance with the use of external speakers, or earbuds or headphones that fit over or under PPE.
Zoom+Care, of Portland, Ore., said it is now offering virtual health visits with specialists for patients in Oregon and Washington. Patients can use the company's telehealth service, Videocare, for dermatology, gynecology, orthopedic, podiatry, internal medicine and mental health concerns.