CE Mark Approval Granted to Kantaro COVID-SeroKlir and COVID-SeroIndex Quantitative Antibody Test Kits
Kantaro Biosciences, in partnership with Bio-Techne Corporation, has secured CE marking for its COVID-SeroKlir and COVID-SeroIndex antibody test kits. These quantitative tests, now available to authorized clinical labs in the EU, provide crucial data about COVID-19 antibody presence and levels. COVID-SeroKlir demonstrates 97.8% sensitivity and 99.6% specificity, supporting both clinical and research applications. Kantaro aims to produce up to 10 million tests monthly, enhancing pandemic response efforts.
- CE marking obtained for COVID-SeroKlir and COVID-SeroIndex tests.
- Tests show high sensitivity (97.8%) and specificity (99.6%).
- Production capacity of up to 10 million tests per month planned.
- None.
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
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.
"Confirming past COVID-19 infection with specific numerical values helps patients to take control of their health and provides vital information for the clinician trying to understand the long-term impact of COVID-19 on other health issues such as cardiac, lung and kidney health," said Sara Barrington, Kantaro's chief commercial officer. "Additionally, knowing specific levels of neutralizing antibodies a person has produced is an important part of understanding immunity and supporting long-term public health strategies."
"COVID-SeroKlir and COVID-SeroIndex receiving CE mark approval is an important step in the global commercialization plan for these best-in-class quantitative antibody test kits," said Chuck Kummeth, Bio-Techne's president and chief executive officer. "We are prepared to produce up to 10 million tests per month and ready to support any further rapid expansion."
About Kantaro Biosciences
Kantaro Biosciences ("Kantaro"), a Mount Sinai Health System venture, is dedicated to ensuring that high-quality diagnostic tests for critical health challenges are accessible. The company provides rigorous, results-driven and reproducible diagnostics to advance the care and well-being of people, communities and society. Kantaro specializes in the rapid scale-up of groundbreaking diagnostic innovations and the creation of partnerships to bring these crucial technologies to market. For more information, visit www.kantarobio.com or @KantaroBio.
About Bio-Techne
Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With thousands of products in its portfolio, Bio-Techne generated approximately
About the Mount Sinai Health System
The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai is a national and international source of unrivaled education, translational research and discovery, and collaborative clinical leadership ensuring that we deliver the highest quality care—from prevention to treatment of the most serious and complex human diseases. The Health System includes more than 7,200 physicians and features a robust and continually expanding network of multispecialty services, including more than 400 ambulatory practice locations throughout the five boroughs of New York City, Westchester, and Long Island. The Mount Sinai Hospital is ranked No. 14 on U.S. News & World Report's "Honor Roll" of the Top 20 Best Hospitals in the country and the Icahn School of Medicine as one of the Top 20 Best Medical Schools in country. Mount Sinai Health System hospitals are consistently ranked regionally by specialty and our physicians are in the top
For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Twitter and YouTube.
About Renalytix AI
Renalytix AI is a developer of artificial intelligence-enabled clinical in vitro diagnostic solutions for kidney disease, one of the most common and costly chronic medical conditions globally. The Company's products are being designed to make significant improvements in kidney disease diagnosis, transplant management, clinical care, patient stratification for drug clinical trials, and drug target discovery. For more information, visit renalytixai.com.
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SOURCE Kantaro Biosciences LLC
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