Pattern Computer Inc.'s test for SARS-CoV-2 infection gives new meaning to rapid results. Taking 15 seconds from start to result, the test offers balanced accuracy of better than 96%, according to the company. The test is also not dependent on timing, unlike current antibody tests, and takes less time than point-of-care PCR tests. Its light-based system creates patterns based on a saliva sample, which is then matched against a previously developed model.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diabetomics, Oticon Medical, Otolith Labs, Sorrento Therapeutics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biomerica, Canon Medical Systems, Cmic, Cutiss, Draper, Haven Testing, Immudex, Invivoscribe, Johnson & Johnson, Lokavant, Medtronic, Merck, Novarad, Nucleai, Omron Healthcare, Penumbra, Rapid AI, Surfacide, United Therapeutics.
Medigen Vaccine Biologics Corp. released results from a phase III trial of its enterovirus 71 (EV71) vaccine that showed efficacy of 100% against a virus that causes hand, foot and mouth disease and continues to emerge on a regular basis across Asia.
PERTH, Australia – Starpharma Holdings Ltd. is pausing sales of its antiviral nasal spray, Viraleze (SPL-7013), in the U.K. after its retail partner, Lloydspharmacy, received a letter from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) related to promotional claims made about the antiviral with respect to SARS-CoV-2 and COVID-19.
LONDON – New data from a randomized community study involving more than half a million people has shown that of 92,116 who had symptomatic COVID-19, 38% were still reporting symptoms 12 weeks later.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BD, Cardiofocus, Flo Health, Hologic, Innova, Integrity Implants, New View Surgical, Penumbra.
Although the U.S. CDC considers myocarditis to be a rare event linked to mRNA COVID-19 vaccines, the FDA is adding a warning about the adverse event to its doctor and patient fact sheets for the vaccines.
It has been a bumpy rollercoaster ride for many biopharma companies throughout the pandemic, but overall, the 17 firms that make up BioWorld’s Infectious Disease Index are coming out ahead this year with stocks up by 44.8%.
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