Kantaro Biosciences, a joint venture between the Mount Sinai Health System and RenalytixAI, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for COVID-SeroKlir, its semi-quantitative SARS-CoV-2 IgG antibody test kit. The COVID-SeroKlir determines the presence and precise level of IgG antibodies and has a broad range of applications in the fight against COVID-19. Through a commercial partnership with Bio-Techne 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.
COVID-SeroKlir 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. COVID-SeroKlir is a two-step enzyme-linked immunosorbent assay (ELISA) and can be used by any CLIA-certified laboratory without the need for proprietary equipment. The Kantaro test kit received CE mark in October 2020 and is available in 29 countries in Europe.
"COVID-SeroKlir is based on Mount Sinai technology that was developed at the height of the COVID-19 pandemic in New York City," said Sara Barrington, Kantaro's chief commercial officer. "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."
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"Widespread testing is critical in the fight against COVID-19. With this EUA in hand, we are ready to immediately supply this best-in-class serologic assay to clinicians across the U.S.," said Chuck Kummeth, president and chief executive officer of Bio-Techne Corporation. "Manufacturing will begin with a capacity of up to 10 million tests per month. We anticipate that COVID-SeroKlir will play an increasingly important role in the decision making of healthcare providers and policymakers and are prepared to scale up to meet additional demand."
Mount Sinai developed the underlying technology in COVID-SeroKlir, which has been used and validated in a highly diverse population of over 80,000 patient samples. Data show that most people who have had COVID-19 mount a robust antibody response that remains relatively stable for at least five months following infection. This antibody response correlates with the body's ability to neutralize SARS-CoV-2.
COVID-SeroKlir is a semi-quantitative SARS-CoV-2 IgG antibody test kit. It detects both the presence and the level of IgG antibodies without the need for proprietary equipment. COVID-SeroKlir has 98.8% sensitivity and 99.6% specificity resulting from a two-step process that detects antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain. Mount Sinai developed the test's underlying technology, which has been used over 80,000 times on a highly diverse patient population. COVID-SeroKlir received Emergency Use Authorization by the FDA and CE marking for use in Europe.