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BioWorld - Thursday, April 16, 2026
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Home » Kantaro receives FDA EUA for COVID antibody test
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Kantaro receives FDA EUA for COVID antibody test

Nov. 25, 2020
By Liz Hollis
Kantaro Biosciences LLC, a joint venture between the Mount Sinai Health System and RenalytixAI, has received emergency use authorization from the U.S. FDA for its semi-quantitative SARS-CoV-2 IgG antibody test kit. Known as COVID-Seroklir, the test determines the presence and precise level of IgG antibodies. It has demonstrated 98.8% sensitivity and 99.6% specificity for detecting SARS-CoV-2 specific IgG antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain.
Medical technology Newco news Regulatory Diagnostics Coronavirus FDA

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