CE Mark Approval Granted to Kantaro COVID-SeroKlir and COVID-SeroIndex Quantitative Antibody Test Kits

-The quantitative test kits detect the level of COVID-19 antibodies that correlate to virus neutralization

-Kantaro test achieves 97.8% sensitivity and 99.6% specificity for the presence of COVID-19 antibodies

-Because no proprietary equipment is required, the Kantaro kits are scalable across global testing laboratories

NEW YORK, Oct. 26, 2020 /PRNewswire/ -- Kantaro Biosciences, LLC (Kantaro), a joint venture between the Mount Sinai Health System and RenalytixAI (LSE:RENX / NASDAQ: RNLX), and partner Bio-Techne Corporation (NASDAQ: TECH) have received CE marking for COVID-SeroKlir and COVID-SeroIndex, Kantaro's quantitative SARS-CoV-2 IgG antibody test kits. Both kits are available immediately and can be used by any authorized clinical testing laboratory in the European Union without the need for proprietary equipment. Approved as in vitro diagnostics (IVD), COVID-SeroKlir is configured to be most useful in a clinical setting, while the COVID-SeroIndex configuration is expected to be used for research purposes or vaccine development.

The COVID-SeroKlir and COVID-SeroIndex quantitative antibody test kits detect the presence or absence of COVID-19 antibodies and measures the titer (level) of antibodies a person has produced. The tests utilize not one but two virus antigens: the full-length spike protein and its receptor-binding domain (RBD), which are correlated with antibody neutralization, as described in a recent paper published in Nature Medicine. The COVID-SeroKlir quantitative antibody test kit has demonstrated 97.8% sensitivity and 99.6% specificity.

The underlying technology in Kantaro's test kits was developed by Mount Sinai at the height of the COVID-19 pandemic in New York City. It was used recently in a published study by researchers at the Icahn School of Medicine at Mount Sinai, which found most people with COVID-19 mount a robust antibody response stable for at least three months, which subsequent studies have extended out to six months. To date, the Mount Sinai technology has been used on over 75,000 patients, representing a highly diverse population.