NDA Partners Awarded Government Contract to Conduct Reviews of EUAs for Laboratory Developed Tests for COVID-19
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NDA Partners President, Earle Martin, announced today that the company has been awarded a contract with the US Department of Health & Human Services to conduct technical and regulatory reviews of applications for Emergency Use Authorizations (EUAs) submitted for laboratory developed tests for COVID-19.
We are honored to have been selected to play a role in the support of this heroic effort by the Office of the Assistant Secretary for Health (OASH) to expand COVID-19 testing in local communities. ROCHELLE, Va. (PRWEB) January 12, 2021
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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 mutations, including a new variant strain of SARS-CoV-2 (B.1.1.7) in the U.K. and more recently in the U.S., to determine the impact on its PCR test sensitivity. The B.1.1.7 strain is detectable by our current molecular testing, the company said. A Quest Diagnostics spokesperson said the company believes its molecular testing services are able to detect the recently identified U.K. and South
1. “An Evolving Situation”
There are three moments in the yearlong catastrophe of the
COVID-19 pandemic when events might have turned out differently. The first occurred on January 3, 2020, when Robert Redfield, the director of the Centers for Disease Control and Prevention, spoke with George Fu Gao, the head of the Chinese Center for Disease Control and Prevention, which was modelled on the American institution. Redfield had just received a report about an unexplained respiratory virus emerging in the city of Wuhan.
The field of public health had long been haunted by the prospect of a widespread respiratory-illness outbreak like the 1918 influenza pandemic, so Redfield was concerned. Gao, when pressed, assured him that there was no evidence of human-to-human transmission. At the time, the theory was that each case had arisen from animals in a “wet” market where exotic game was sold. When Redfield learned that, among twenty-seven reported cases, there were several famil
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 has been shown to lower the SARS-CoV-2 viral infection of cells, according to the FDA.