NEW YORK, November 25, 2020 / PRNewswire / – Kantaro Biosciences, LLC, a joint venture between Mount Sinai Health System and RenalytixAI (NASDAQ: RNLX), received an Emergency Food and Drug Administration (FDA) Authorization from the US Food and Drug Administration (FDA) for COVID-SeroKlir semi-quantitative SARS-CoV-2 IgG antibody test kit. Unlike other antibody tests, COVID-SeroKlir determines the presence and precise level of IgG antibodies and has a wide range of applications in the fight against COVID-19. Through a commercial partnership with Bio-Techne Corporation (NASDAQ: TECH) test kits are manufactured on a scale with a capacity of up to 10 million tests per month and the possibility of increase.
Measuring IgG antibody levels with COVID-SeroKlir can inform health decision making and assess the response to the vaccine.
COVID-SeroKlir showed 98.8% sensitivity and 99.6% specificity for the detection of SARS-KOV-2 specific IgG antibodies against two viral antigens, the full-length spike protein and its receptor binding domain. COVID-SeroKlir is a two-step enzyme immunosorbent assay (ELISA) and can be used by any CLIA-certified laboratory without the need for commercial equipment. The Cantaro test kit received the 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 KOVID-19 pandemic in New York, “he said Sarah Barrington, Chief Commercial Officer of Cantaro. “It is a high-performance test that quantifies antibody levels for individuals that medical professionals and policymakers can trust. Having a numerical understanding of antibody levels can be particularly powerful for patients, allowing them to take control.” over their health and enjoy peace of mind in these uncertain times. “
Measuring IgG antibody levels with COVID-SeroKlir can inform health decision-making strategies and public health, as well as assess the response to the vaccine. Semi-quantitative antibody testing is also an essential component of general health screening to detect past infections with KOVID-19. An increased risk of potentially life-threatening complications, including diseases of the lungs, kidneys, and cardiovascular system, is associated with COVID-19.
“Widespread testing is crucial in the fight against KOVID-19. “With this EUA in hand, we are ready to immediately deliver this best-in-class serological analysis to clinicians across the United States.” Chuck Kummet, President and CEO of Bio-Techne Corporation. “Production will start with a capacity of up to 10 million tests per month. We expect COVID-SeroKlir to play an increasingly important role in the decision-making of health care providers and policy makers and are ready to increase needs to meet additional demand.”
Mount Sinai developed the core technology in COVID-SeroKlir, which has been used and validated in a very diverse population of over 80,000 patient samples. The peer-reviewed Science magazine recently published five-month current data Mount Sinai study using basic technology. The data show that most people who have COVID-19 mount a strong antibody response that remains relatively stable for at least five months after infection. This antibody response correlates with the body’s ability to neutralize SARS-CoV-2.
COVID-SeroKlir is a semi-quantitative kit for testing SARS-CoV-2 IgG antibodies. Detects the presence and level of IgG antibodies without the need for commercial equipment. COVID-SeroKlir has 98.8% sensitivity and 99.6% specificity resulting from a two-step process that detects antibodies against two viral antigens, the full-length spike protein and its receptor binding domain. Mount Sinai developed the basic test technology, which has been used over 80,000 times in a very diverse population of patients. COVID-SeroKlir has been authorized for emergency use by the FDA and CE marking for use in Europe.
For Biological Sciences Cantaro
Kantaro Biosciences (“Cantaro”), an enterprise of the Sinai Mountains health system, is committed to providing high-quality diagnostic tests for critical health challenges. The company provides rigorous, results-driven and reproductive diagnostics to enhance the care and well-being of people, communities and society. Kantaro specializes in rapidly expanding rapid diagnostic innovations and partnerships to bring these key technologies to market. For more information, visit www.kantarobio.com and follow Kantaro on Twitter @KantaroBio.
Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company that provides innovative tools and bioactive reagents to research and clinical diagnostic communities. Bio-Tech products assist in scientific research on biological processes and the nature and progression of specific diseases. They assist in drug discovery efforts and provide the means for accurate clinical trials and diagnoses. With thousands of products in its portfolio, Bio-Techne has generated approximately $ 739 million in net sales in fiscal 2020 and has over 2,300 employees worldwide. For more information on Bio-Techne and its brands, visit www.bio-techne.com.
About the health system of Mount Sinai
Mount Sinai’s health system New York the largest academic medical system, comprising eight hospitals, a leading medical school and a vast network of outpatient practices throughout the New York region. Mount Sinai is a national and international source of irreplaceable education, translation research and discovery and collaborative clinical leadership that ensures that we provide the highest quality of care – from prevention to treatment of the most serious and complex human diseases. The health system includes more than 7,200 physicians and has a robust and ever-expanding network of multidisciplinary services, including more than 400 outpatient locations across the five districts of New York, Westchester, и Long Island. Mont Sinai Hospital is ranked No. 14 on US News & World Report’s “Honor Roll” from the Top 20 best hospitals in the country and Ikan Medical School as one of the Top 20 best medical schools in the country. The hospitals of the health system of Mount Sinai are ranked on a regional level according to the specialty and our doctors are in the top 1% of all doctors on a national level according to American News and World Report.
For more information, visit https://www.mountsinai.org or find Mount Sinai On Facebook, Twitter and YouTube.
For Renalitics AI
Renalytix AI is the developer of clinical in vitro diagnostic solutions with the possibility of artificial intelligence for kidney disease, one of the most common and most expensive chronic medical conditions globally. The Company’s products are designed to make significant improvements in the diagnosis of renal disease, transplant management, clinical care, patient stratification for clinical trials of drugs, and disclosure of drug targets. For more information, visit renalytixai.com.
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