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.
The issue of the U.S. federal government’s response to the COVID-19 pandemic was revisited yet again in a hearing in the House of Representatives. While partisanship was on full display, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he is “cautiously optimistic” about the prospects for a vaccine and that the development of candidates has not compromised scientific principles.
Six months to the day that the World Health Organization (WHO) declared it a public health emergency, the SARS-CoV-2 virus, with its hideous red spikes, continues to taunt the world, hopping from host to host and haunting humans, many of whom wonder the same thing: What’s next?
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 7D Surgical, Abingdon Health, Ethicon, Quest Diagnostics, Seegene.
