Page 8 - Tim Stenzel News Today : Breaking News, Live Updates & Top Stories | Vimarsana

Link Copied The Department of Health and Human Services is paying a private firm to review the accuracy of some Covid-19 tests — the latest example of the department’s political leadership attempting to bypass scientists at the Food and Drug Administration. The idea behind the last-minute contract, announced days before President Donald Trump leaves office, is that HHS would use the review to issue emergency use authorizations for the tests without input from FDA. It comes as the health department has scrambled to force through several new FDA regulations — sometimes without the agency�...

Dive Brief: FDA on Wednesday said it is working with SARS-CoV-2 test developers to determine potential impact on the efficacy of coronavirus diagnostics as a coronavirus variant first identified in the U.K. has now been found in the U.S. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, told Wednesday's virtual town hall for test developers the agency is trying to assess whether existing coronavirus tests are able to properly detect new COVID-19 variants. Separately, lab giant LabCorp on Monday issued a statement that it is "tracking" coronavirus mu...

This story provided by Ohio Northern University HealthWise Pharmacy. (RxWiki News) The US Food and Drug Administration (FDA) approved a new test that can detect neutralizing antibodies from a past SARS-CoV-2 infection. It's the first test of its kind. The FDA has granted more than 50 antibody (serology) tests an emergency use authorization (EUA). This newly approved test, called cPass SARS-CoV-2 Neutralization Antibody Detection Kit, was one of them. But this test is different. This test can detect neutralizing antibodies, which are antibodies that bind to a certain part of a pathogen that ha...