Developers of tests for the SARS-CoV-2 virus have gained a tremendous amount of experience in a very small amount of time, and of all the media for sampling, saliva offers the easiest route for test administration. The U.S. FDA’s Tim Stenzel said on the Aug. 5 testing town hall, however, that the FDA and developers have discovered that this is an extremely difficult medium to work with.
The U.S. FDA gave an emergency use authorization (EUA) to the first semi-quantitative antibody test from Siemens Healthineers AG for the SARS-CoV-2 virus. This test, known as the SARS-CoV-2 IgG (COV2G) antibody test, could potentially be used repeatedly over time to assess relative levels to gauge potential immunity.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Biotricity, Siemens Healthineers.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: American College of Radiology, Asuragen, Bio-Techne, Brain Scientific, China Grand Pharmaceutical and Healthcare, Clinical Reference Laboratory, Co-Diagnostics, Iotron Industries, Kantaro Biosciences, Karius, Medicrea, Mount Sinai Health System, Pacific Biosciences, Personalis, Quest Diagnostics, Renalytix AI, Sirtex Medical, Sotera Health, Sterigenics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied DNA Sciences, Clinical Reference Laboratory.
