Kantaro Biosciences announced today that it received FDA emergency use authorization (EUA) for its COVID-SeroKlir antibody test.
New York-based Kantaro, a joint venture between Mount Sinai Health System and RenalytixAI (NSDQ:RNLX), developed the semi-quantitative SARS-CoV-2 IgG antibody test kit to determine the presence and precise level of IgG antibodies related to COVID-19.
A partnership with Bio-Techne, struck up in May of this year, means that the test kits are being manufactured at scale with a capacity of up to 10 million tests per month, as well as the ability to scale up further down the line, according to a news release.
COVID-SeroKlir has demonstrated 98.8% sensitivity and 99.6% specificity in detecting SARS-CoV-2-specific IgG antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain. The kit received CE Mark approval in October 2020 and is available across 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,” Kantaro CCO Sara Barrington said in the release. “It is a high performing test that quantifies antibody levels for individuals, which medical professionals and policymakers alike can trust. Having a numerical understanding of antibody levels can be especially powerful for patients, enabling them to take control of their health and enjoy some peace of mind during these uncertain times.”
Shares of RNLX skyrocketed upon the release of the news of the authorization, rising nearly 34% at $14.30 in midday trading today.