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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Biocode, Fist Assist, Mdoloris, Mindray.
A cocktail of monoclonal neutralizing antibodies developed by Brii Biosciences Ltd. has become “the first locally-discovered and approved SARS-CoV-2 target-specific treatment in China, through a randomized, double-blind and placebo-controlled trial,” Rogers Luo, president and general manager of greater China at the company, told BioWorld.
LONDON – There was a substantial fall in neutralization titers against the Omicron variant of SARS-CoV-2 in the stored sera of people who had received two doses of either Astrazeneca plc’s or Pfizer Inc./Biontech SE’s COVID-19 vaccines, with some samples failing to neutralize the virus at all, according to the latest data from the U.K. Com-Cov study.
The European Investment Bank (EIB) is continuing a streak of investments in the med-tech space, signing a €20 million (US$22 million) loan agreement with Midiagnostics NV, to scale-up a new rapid COVID-19 PCR test. Leuven, Belgium-based Midiagnostics is developing a rapid PCR test for SARS-CoV-2, which can achieve an accuracy speed 20 times faster than classic PCR machines. A nasopharyngeal swab sample is transferred on a PCR testcard, from which the results are read by a compact reader. Pilot programs for the test began at Brussels Airport this month, with a market launch pegged for Spring 2022.
