FDA grants EUA to Kantaro for COVID-19 serology test

2020 09 08 20 55 7263 Fda Drugs Approval 400

Kantaro Biosciences has received an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a quantitative serology test for the novel coronavirus.

The COVID-SeroKlir is a semiquantitative SARS-CoV-2 immunoglobin G (IgG ) antibody test kit that determines the presence and precise levels of IgG antibodies in samples and can be used in any CLIA-certified lab. The test, which is a joint venture among Kantaro, Mount Sinai Health System, and RenalytixAI, 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, according to the firm.

The test kits are being manufactured at scale with a capacity of up to 10 million tests per month and the ability to scale up through a commercial partnership with Bio-Techne.

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