PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released guidance for sponsors and manufacturers on regulatory requirements for software to be used with COVID-19 rapid antigen self-tests that are intended to analyze and interpret tests results.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abiomed, Caredx, Castle Biosciences, Electrocore, Glaukos, Pictor.
The FDA reported a class I recall of the Wirion embolic protection device by Cardiovascular Systems Inc. (CSI), of St. Paul, Minn., due to reports of nine instances of device malfunction. The agency said the filter portion of the device can be difficult to withdraw under some circumstances and thus lead to separation, although the FDA noted that no deaths have been reported in association with the issue despite the risk of embolization. The FDA’s device center also posted a Jan. 11 notification against the use of two tests by Lusys Labs Inc., of San Diego, for the SARS-CoV-2 virus.
LONDON – T cells generated as a result of infection with common cold coronaviruses provide cross-protection against being infected with SARS-CoV-2, according to a new study.
Just as the world appeared to be winning the battle against COVID-19, the rules of the game changed. Omicron and concerns about future variants flipped the board. Vaccines and monoclonal antibodies are attracting fresh scrutiny as SARS-CoV-2 evolves. Cases are climbing closer to the highest levels recorded since the pandemic began. Antivirals are aiming to fill treatment gaps, but whether they will or not is about as clear as the virus’ next move.
The run on at-home COVID-19 tests may be for naught. The FDA warned that the popular rapid antigen tests recommended to keep New Year’s Eve revelers, relatives visiting elderly grandparents and workers exposed to the coronavirus from spreading COVID-19 are less likely to detect the Omicron variant than earlier strains of the virus. “Early data suggest that antigen tests do detect the Omicron variant but may have reduced sensitivity,” the agency said in an update on Dec. 29. Despite the higher rate of false negatives, the FDA said individuals should continue to use the tests. Those experiencing symptoms or with a high likelihood of infection based on exposure should follow-up with a molecular test if their antigen test returns a negative result.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Siemens Healthineers.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Co-Defend, Co-Protect, Lucira, Pacbio, Seegene.
LONDON – A suite of papers rushed through peer review and published in Nature late on Dec. 23, 2021 contain data indicating approved monoclonal antibody drugs designed to neutralize SARS-COV-2 have substantially weaker activity against the Omicron variant.
As the Omicron variant of COVID-19 sweeps across the globe, the Biden administration has announced a program to purchase 500 million rapid antigen tests to help slow the pandemic. The news comes at an especially critical time, given the increased transmissibility of the Omicron variant, but the promised volume is unlikely to be achieved by the first day of January 2022.
