The U.S. FDA has granted emergency use authorization (EUA) to Lumiradx UK Ltd. for its point-of-care SARS-CoV-2 antigen test, which aims to speed the diagnosis of people suspected of having the virus that causes COVID-19. The test detects antigen nucleocapsid protein from a nasal swab taken from symptomatic patients and delivers results in less than 12 minutes.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Curetis, Lumiradx, Opgen, Pelvital, Zymo Research.
Keeping you up to date on recent developments in diagnostics, including: Antigen test detects spike proteins of SARS-CoV-2; Blood volume assessment study to use Daxor device; Gaining insights into loss of function.
Advanced talks between the European Commission and Curevac AG have positioned the company to potentially supply up to 405 million doses of its investigational mRNA-based COVID-19 vaccine to the bloc. News of the progress, following similar EU-level talks with an alliance of Sanofi SA and Glaxosmithkline plc, Johnson & Johnson and Astrazeneca plc, sent Curevac's recently-listed U.S. shares (NASDAQ:CVAC) climbing 16% to $66 on Aug. 20.
Avoiding the political overtones that seem to be more viral than COVID-19 these days, Anand Shah, deputy commissioner for medical and scientific affairs at the FDA, stressed that even though the agency is making decisions in real time in response to the urgency of the pandemic in the U.S., its decisions are being driven by scientific integrity, regulatory independence and the FDA’s historic commitment to ensuring the safety and efficacy of the products it regulates.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Annovis, Ascletis, Aquestive, CNS, Entera, Immunic, Matinas, Orgenesis, Puma, Regeneron, Revive, Viiv.
Thermo Fisher Scientific Inc. released updated software and new instructions for its Taqpath COVID-19 Combo Kit, a widely used COVID-19 test kit that is also the basis for several other coronavirus diagnostics, following issuance of a letter to clinical laboratory staff and health care providers by the U.S. FDA about the risk of false results with the test. Separately, the Waltham, Mass.-based company has released the first in a series of hematology-oncology assays designed to run on its Ion Torrent Genexus system.
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