Dallas-based Affinity Health Partners, a rural health system owner and operator, is bringing a point of care COVID-19 test to its facilities and network partners facilities in April. The rapid antibody CE marked point of care test is currently being offered pursuant to the Policy for Coronavirus (COVID-19) Disease Testing by the U.S. FDA. The test is currently being utilized in Europe and China and was developed three years ago during another corona-based virus epidemic. This screening test is designed as a simple to use, easily deployable inexpensive test that does not require any laboratory intervention. Using a spot of capillary blood from a finger stick, the screener receives a result in about 10 minutes. The result reveals if the patient is positive or negative for primary and secondary SARS-CoV-2 infection and qualitative detection of lgG and IgM antibodies to SARS-CoV-2.
Bellaseno GmbH, of Leipzig, Germany, reported a collaboration with Charité – Universitätsmedizin Berlin under the recently established Symbod consortium. Under the agreement, Bellaseno will design and manufacture personalized, 3D-printed, absorbable implants suitable for the treatment of diabetes patients with bone defects. The goal is to restore blood supply and facilitate the regeneration of persistent bone defects that do not heal.
San Diego-based Decipher Biosciences Inc. reported that the Decipher Prostate RP genomic test is recommended in the 2020 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology to inform treatment for men with adverse pathology following radical prostatectomy. Further, the guideline recommendations for men with newly diagnosed prostate cancer have been expanded beyond consideration of Decipher Prostate Biopsy in low- and favorable intermediate-risk disease to include unfavorable intermediate- and high-risk prostate cancer.
Dearborn, Mich.-based Ford Motor Company, is joining forces with Saint Paul, Minn.-based 3M Co. and Chicago-based GE Healthcare, to lend its manufacturing and engineering expertise to expand production of medical equipment and supplies for health care workers, first responders and patients fighting COVID-19. In addition, Ford plans to assemble more than 100,000 face shields per week and leverage its in-house 3D printing capability to produce components for use in personal protective equipment. Ford team members are working with 3M to increase the manufacturing capacity of their powered air-purifying respirator designs. In addition, a new respirator could be produced in a Ford facility by the United Auto Workers. Ford and GE Healthcare are working together to expand production of a simplified version of the latter’s existing ventilator design to support patients with respiratory failure or difficulty breathing caused by COVID-19. These ventilators could be produced at a Ford manufacturing site in addition to a GE location. Work on this initiative ties to a request for help from U.S. government officials. Meanwhile, Ford’s U.S. design team also is creating and starting to test transparent full-face shields for medical workers and first responders. Ford is leveraging its Advanced Manufacturing Center in Redford, Mich., and in-house 3D printing capabilities to manufacture components and subassemblies for use in personal protective equipment.
Fiat Chrysler Automobiles (FCA), which has a U.S. presence in Auburn Hills, Mich., is donating more than 1 million protective face masks per month. Production capacity is being installed this week, and the company will start manufacturing face masks in the coming weeks with initial distribution across the U.S., Canada and Mexico. The face masks are to be donated by FCA to police, emergency medical technicians and firefighters, as well as workers in hospitals and health care clinics.
Genmark Diagnostics Inc., a Carlsbad, Calif.-based provider of automated, multiplex molecular diagnostic testing systems, won a grant from the Biomedical Advanced Research and Development Authority (BARDA). As a result, BARDA will provide the company with up to $749,000 in funding to develop and pursue U.S. FDA emergency use authorization of a diagnostic panel that incorporates the new SARS-CoV-2 viral target into the company’s existing Eplex Respiratory Pathogen panel.
Atlanta-based Global Center for Medical Innovation (GCMI) reported a collaboration that addresses the shortage of personal protective equipment. The initiative provides, free-of-charge, the designs, with necessary regulatory guidance, for any good manufacturing practice-compliant facility to use in the production and distribution of face shields to health care workers. The initiative is a collaboration between GCMI; Joanna Newton, pediatric hematologist/oncologist, Aflac Center and Blood Disorders Center of Children’s Healthcare of Atlanta and assistant professor of pediatrics, Emory University School of Medicine; Children’s Healthcare of Atlanta Pediatric Technology Center; and a team of scientists and researchers at the Georgia Institute of Technology and its Invention Studio.
Heat Biologics Inc., of Morrisville, N.C., is collaborating with the University of Miami to develop a proprietary COVID-19 point-of-care diagnostic test. The test will require a pharyngeal throat swab to deliver on-the-spot results on a paper strip in less than 30 minutes.
Intervenn Biosciences, of Redwood City, Calif., added a colorectal cancer/advanced adenoma diagnostic panel to its proprietary glycoproteomic analysis platform.
New York-based Letsgetchecked is releasing the first two-part test for COVID-19, allowing patients who are under the care of health care professionals to receive immediate indication for the presence or absence of infection while more complete laboratory tests are conducted. The test will be available March 30, initially in the U.S. only, with health care workers on the frontline prioritized.
Maxcyte Inc., a Gaithersburg, Md.-based global cell-based therapies and life sciences company, and Allogene Therapeutics Inc., a South San Francisco-based biotechnology company focused on the development of allogeneic CAR T therapies for cancer, reported a clinical and commercial license agreement. Under the terms of the agreement, Allogene gains rights to use Maxcyte's flow electroporation technology and Expert platform to develop and advance its AlloCAR T candidates through to commercialization. In return, Maxcyte will receive undisclosed development, approval and commercial milestones in addition to other licensing fees. The first two Allogene investigational therapies intended to utilize this validated gene editing and advanced proprietary cell manufacturing technology are directed at CD19 and BCMA targets.
Nano-X Imaging Ltd., a Neve Ilan, Israel-based medical imaging company, reported its collaboration with Curemetrix Inc., a La Jolla, Calif.-based company that develops artificial intelligence (AI)-driven software for radiology, to integrate the Curemetrix advanced AI diagnostics solution into Nanox’s planned cloud-based software platform, the Nanox.Cloud.
No Borders Inc., of Queen Creek, Ariz., executed an agreement with its existing suppliers in Hong Kong to bring its 15-minute at home serological COVID-19 test to the U.S.
Nuclein LLC, of Austin, Texas, plans to expedite the commercialization of its Nuclein handheld polymerase chain reaction test. The company anticipates moving into product manufacturing soon, with the objective of launching its COVID-19 test by this fall.
Pathsensors Inc., a Baltimore-based biotechnology company, is developing a Canary biosensor to detect the SARS-CoV-2, the causal agent for the coronavirus disease COVID–19. The biosensor will be available for research purposes in May, and validation data on the new SARS-CoV-2 product will be available the following month.
Chicago-based Protex Products LLC reported the availability of Pbx-Cr, a product for hygienic and chemically resistant, temporary surface protection, for use in temporary medical facilities treating COVID-19 cases.
Clinical laboratory services company Q2 Solutions, of Morrisville, N.C., a joint venture of Iqvia Holdings Inc., of Durham, N.C., and Quest Diagnostics Inc., of Secaucus, N.J., is teaming up with the University of Texas Medical Branch to develop an assay for COVID-19 tests. Once developed, Q2 Solutions will produce it for use in clinical trials to assess the effectiveness of a vaccine.
Venlo, Netherlands-based Qiagen NV said it has begun shipping its Qiastat-Dx Respiratory SARS-CoV-2 Panel test to the U.S. to aid in COVID-19 diagnosis and will submit an emergency use authorization request to the FDA this week.
Tamarin Health, a digital health company based in Brighton, Mass., reported the launch of its Sana virtual patient support network to aid clinicians during the COVID-19 pandemic.
U.K.-based University of Birmingham has joined the COVID-19 Genomics UK Consortium, a genome sequencing alliance that aims to map the spread of COVID-19. The university said it has deployed a real-time genome sequencing facility capable of sequencing genomes of the novel coronavirus from patients in the West Midlands in under 24 hours. Through a £20 million ($23.6 million) investment, the consortium will look for breakthroughs that help the U.K. response to the current and future pandemics.
Vero Biotech LLC, of Atlanta, reported the first patient with COVID-19-related complicating pulmonary hypertension was treated at home with its Genosyl DS tankless inhaled nitric oxide delivery system. The patient was treated under an FDA-approved emergency IND. The patient also received oxygen via nasal canula and was monitored remotely, avoiding hospitalization and more intensive respiratory support.
Zoll Medical Corp., of Chelmsford, Mass., an Asahi Kasei Group company, said it plans to manufacture 10,000 ventilators a month in response to the COVID-19 pandemic – a 25-fold increase over recent production volumes. The company has reached out to its supply chain to assist in meeting the demand.