FDA Adds Kantaro's Semi-Quantitative COVID-19 Antibody Test to Revised Emergency Use Authorization for Convalescent Plasma
Kantaro Biosciences, a joint venture with RenalytixAI and Bio-Techne, announced that the FDA has added its COVID-SeroKlir antibody test to the Emergency Use Authorization (EUA) for convalescent plasma treatment in hospitalized COVID-19 patients. The test, which detects SARS-CoV-2 IgG antibodies with 98.8% sensitivity and 99.6% specificity, aims to qualify high titer convalescent plasma. Kantaro emphasizes the test's potential role in advancing COVID-19 therapeutics, having been used nearly 90,000 times across diverse populations since its initial FDA authorization in November 2020.
- FDA's addition of COVID-SeroKlir to EUA enhances market accessibility for Kantaro's test.
- COVID-SeroKlir shows high sensitivity (98.8%) and specificity (99.6%), indicating reliable performance.
- The test has been utilized close to 90,000 times, demonstrating strong demand and application.
- COVID-19 convalescent plasma is still considered an investigational product, lacking full approval.
NEW YORK, Feb. 10, 2021 /PRNewswire/ -- Kantaro Biosciences, LLC, a joint venture between the Mount Sinai Health System and RenalytixAI (LSE:RENX / NASDAQ: RNLX), and manufacturing partner Bio-Techne Corporation (NASDAQ: TECH), announced that the U.S. Food and Drug Administration (FDA) has added COVID-SeroKlir to the Emergency Use Authorization (EUA) for the use of convalescent plasma for treating COVID-19 in hospitalized patients. COVID-SeroKlir detects the presence and precise level of SARS-CoV-2 IgG antibodies with
The revised EUA qualifies the COVID-SeroKlir test for detecting high titer COVID-19 convalescent plasma during manufacturing. The EUA limits the use of high titer COVID-19 convalescent plasma only to treat hospitalized patients early in the disease course. COVID-19 convalescent plasma is an investigational product and is not currently approved or licensed for any indication.
"We are pleased the FDA has added Kantaro's COVID-SeroKlir antibody test to the EUA for convalescent plasma and authorized the test's use in qualifying convalescent plasma titers," said Erik Lium, PhD, Chairman of the Board of Kantaro and Executive Vice President and Chief Commercial Innovation Officer at the Mount Sinai Health System. "We believe semi-quantitative antibody testing can play an important role in the development of advanced therapeutics for COVID-19 and appreciate that it is being recognized as such."
The high performance of COVID-SeroKlir results from a two-step process that detects antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain. This precision makes the Kantaro test accurate, with a low potential for false results. Mount Sinai developed the test's underlying technology, which has been used close to 90,000 times on a highly diverse patient population. COVID-SeroKlir received Emergency Use Authorization by the FDA in November 2020.
About Kantaro Biosciences
Kantaro Biosciences, a joint venture between the Mount Sinai Health System and RenalytixAI, 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 and follow Kantaro on Twitter @kantarobio.
About Bio-Techne Corporation
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 plc
RenalytixAI 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
FAQ
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