11/25/2020, 2:10 PM (Source: TeleTrader)
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FDA gives EUA to COVID antibody level test

The United States Food and Drug Administration (FDA) on Wednesday gave emergency use authorization (EUA) to Kantaro Biosciences LLC for its COVID-SeroKlir antibody test which gives information on the presence of COVID-19 antibodies as well as their exact level. The test is already available in 29 European countries.

"COVID-SeroKlir is based on Mount Sinai technology that was developed at the height of the COVID-19 pandemic in New York City. It is a high performing test that quantifies antibody levels for individuals, which medical professionals and policymakers alike can trust," Kantaro's chief commercial officer, Sara Barrington, said.

Kantaro also added that the test has shown a 98.8% sensitivity and a 99.6% specificity for detecting the coronavirus' specific IgG antibodies.

Breaking the News / VP