If the SARS-CoV-2 virus has achieved anything useful in the world of in vitro diagnostics, it’s that the associated pandemic has shone a bright and unsparing light on the respective merits of diagnostic and surveillance testing. Harvard University’s Michael Mina, an assistant professor of epidemiology, was one of several academic researchers who took up the gauntlet yet again in opposition to what they characterized as a gross misunderstanding of the respective roles of these types of tests, a misunderstanding they said must be addressed if the pandemic is to be corralled.
Emitbio Inc., a life science company developing light-based therapies, is seeking emergency use authorization (EUA) from the U.S. FDA for its investigational device to treat mild to moderate COVID-19 infection at home. The portable, hand-held device works by directing precise wavelengths of visible light to the back of the throat and surrounding tissues. It is not yet available for sale in the U.S.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agilent, Clearpoint Neuro, Exem Foam, Healthmode, Mindmed, New Horizon Health, Philips, Viewpoint Molecular Targeting.
Just months after a modest IPO, shares of Immunome Inc. (NASDAQ:IMNM) climbed 75.6% on Feb. 18, closing at $39.01. Driving the momentum was an announcement that pseudovirus testing indicates that its antibody cocktail, IMM-BCP-001, appears capable of neutralizing several SARS-CoV-2 variants, an emerging challenge to currently available vaccines and pandemic management efforts.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Delta International Services & Logistics, Everlywell, Horiba Medical, Thermo Fisher Scientific, Vax-Immune Diagnostics.
LONDON – The EU is taking concerted action to detect new variants of SARS-CoV-2, investing €225 million (US$270 million) to increase viral genome sequencing to 5% of positive cases across Europe, and to carry out research on their evolution and transmissibility.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Electrocore, Front Line Medical Technologies, Insightec, Luminostics, Saladax, Shockwave Medical, Smart Medical.
