Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diffusion, Diverse, Lipocine, Mateon, Organicell.
The capacity of U.S. medical providers and testing capacity for the unfolding COVID-19 pandemic continues to be sorely tested. But there is now a new route for people to pursue serological testing to detect who has already been exposed to the SARS-CoV-2 virus.
HONG KONG – Israeli companies have produced some promising med-tech solutions for COVID-19, and the artificial intelligence space is turning out to be a particularly strong area of expertise for that tiny but mighty nation. One of the four health maintenance organizations (HMO) in Israel, Maccabi Healthcare Services, has deployed a new AI-powered algorithm that identifies individuals estimated to be at the highest risk of severe COVID-19 complications due to pre-existing conditions and other health factors.
LONDON – With COVID-19 infection varying in severity from asymptomatic to lethal the search is now underway for biomarkers to predict which patients are most at risk of suffering severe disease. As one possibility, Menarini Silicon Biosystems (MSB) is using its Cellsearch liquid biopsy technology to capture and count circulating endothelial cells. Meanwhile, Oxford Biodynamics plc is applying its Episwitch platform to find prognostic and predictive epigenetic markers.
The FDA has revised its emergency use authorization (EUA) policy for testing for the COVID-19 pandemic, the impact of which falls principally on serological tests for antibodies generated by the SARS-CoV-2 virus. The agency had previously allowed a commercial antibody test developer to distribute a test without submitting the validation data, but makers of such tests now must forward the validation data to the FDA within 10 days, a move prompted in part by inappropriate claims made by some test developers.
Roche Holding AG, of Basel, Switzerland, has garnered U.S. FDA authorization for emergency use of a test to determine whether people have been infected with the novel coronavirus fueling the COVID-19 pandemic. The Swiss health care giant, which also makes molecular tests to detect active COVID-19 infection, claims its Elecsys Anti-SARS-CoV-2 antibody test accurately identifies COVID-19 antibodies in the blood 100% of the time, 14 days post-infection.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aidoc, Cerus, Novartis, Roche, Zoll.
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