The U.S. National Institutes of Health (NIH) has waded into the controversial question of the respective roles of rapid antigen and polymerase chain reaction (PCR) tests for detection of the SARS-CoV-2 virus, a question that roiled relations between the FDA and public health experts. According to NIH, three rapid antigen tests administered at three-day intervals offer the same level of sensitivity as PCR, a finding that will likely make itself felt in future communicable disease outbreaks.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogx, Foundation Medicine, Sonoscape Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Access Bio, Almac Sciences, Areum Bio, Bellaseno, Bio-Rad, Ensysce Biosciences, ERS Genomics, Exothera, Hart Medical Equipment, Icon, Leisure Acquisition Corp., Nippon Gene, Nonacus, Northwest Ohio Medical Equipment, Novigenix, Ossis, Pall, Pamgene, PRA Health Sciences, Qiagen, Seegene, Spinelife.com, Sysmex, Vivera, Zimmer Biomet.
As confirmed cases and deaths from COVID-19 continue their downward slide, biopharma research efforts remain front and center, providing a new therapeutic for emergency use in the U.S. and high-efficacy phase III data for what could become the country’s fourth vaccine and its first protein subunit option.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advanced Accelerator Applications, Avacta, Avicenna.AI, B. Braun, Bioivt, Cancer Targeted Technology, Cognetivity Neurosciences, Ethicon, Medline Industries, Merck, Neuroloop, Novacyt, Nuance, Orthofix Medical, Qiagen, Teleflex, Valley Biomedical Products & Services, Verogen.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Attana, Front Line Medical, Galderma, Neuros Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Asensus Surgical US, DNA Diagnostics Center, Eurofins Scientific, Meridian Bioscience, Newpace, Powermat Technologies, Red One Medical, Rockwell Medical.
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.
