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Kantaro Biosciences Gets Health Canada Authorization for SARS-CoV-2 Antibody Test

NEW YORK — Kantaro Biosciences said on Wednesday that it has received Health Canada Authorization under the COVID-19 Interim Order for its COVID-SeroKlir SARS-CoV-2 antibody test.

The ELISA-based test is designed to detect the presence and level of neutralizing immunoglobulin G, or IgG, against SARS-CoV-2, according to Kantaro. It has shown 98.8 percent sensitivity and 99.6 percent specificity for detecting SARS-CoV-2-specific IgG against two virus antigens: the full-length spike protein and its receptor-binding domain.

"COVID-SeroKlir delivers a numerical understanding of neutralizing antibody levels, not just a yes or no qualitative result, in patients with a past infection as well as those that have been vaccinated," said Sara Barrington, Kantaro's chief commercial officer, in a statement. "It is an important tool that can inform both individual healthcare decision making and public health policy while Canada reopens."

New York City-based Kantaro is a joint venture between the Mount Sinai Health System and RenalytixAI. About a year ago, the company partnered with Bio-Techne on the scaled manufacture and distribution of the SARS-CoV-2 test, which has Emergency Use Authorization from the US Food and Drug Administration and CE marking.