Mount Sinai seeks EUA from Food and Drug Administration for potential quantitative serologic test for COVID-19
Mount Sinai Health System has submitted a request to the U.S. Food and Drug Administration (FDA) for issuance of an Emergency Use Authorization (EUA) for quantitative use of its serologic test. If authorized for quantitative use, the assay could be used to provide a numeric result for the concentration of neutralizing anti-COVID-19 antibodies in plasma.
In April 2020, Mount Sinai Laboratory Center for Clinical Laboratories received FDA EUA for qualitative use of the assay, an enzyme-linked immunosorbent assay or ELISA, that has now been tested on over 40,000 patients and has been a critical component of the hospital’s convalescent plasma program for emergency therapy, and testing of healthcare workers as well as the public. In a comparison of EUA tests published by the FDA (link), the EUA-authorized qualitative test had a PPV of 100%, and an NPV of 99.6%.
Since then, Mount Sinai’s internationally recognized team of virologists and pathologists, including Florian Krammer, PhD, Professor of Microbiology at the Icahn School of Medicine at Mount Sinai, Carlos Cordon-Cardo, MD, PhD, Irene Heinz Given and John LaPorte Given Professor and Chair of Pathology, Molecular and Cell-Based Medicine at Mount Sinai, and Adolfo Firpo-Betancourt, MD, Professor of Pathology, Molecular and Cell Based Medicine at Mount Sinai, have been working intensely to provide new findings and data to support what they hope will be FDA authorized quantitative use of the assay. The serological assay developed by Dr. Krammer and colleagues for the screening and identification of individuals that have seroconverted was described in a paper published in Nature Medicine on May 12, 2020.
Mount Sinai is hopeful that the FDA will be reviewing this request in the next few weeks. If FDA EUA is issued, Kantaro Biosciences, a Mount Sinai diagnostics venture, will also apply for FDA EUA for a commercial kit based on the Mount Sinai assay. If Kantaro’s EUA is issued, Kantaro and Bio-Techne, a leading life science tools and clinical diagnostics company, expect to provide interested laboratories access to these kits in July.
About Kantaro BioSciences
Kantaro Biosciences (“Kantaro”), a Mount Sinai Health System venture, is dedicated to ensuring that diagnostic tests for critical health challenges are accessible. The company provides academically rigorous, validated and results-driven diagnostics to advance the wellbeing of people, communities and society. Kantaro specializes in the rapid scaleup of groundbreaking diagnostic innovations and the creation of partnerships to bring these crucial technologies to market. The company is majority owned and controlled by Mount Sinai. For more information, visit www.kantarobio.com.
Bio-Techne Corporation (NASDAQ: TECH) is a leading developer and manufacturer of high-quality purified proteins and reagent solutions - notably cytokines and growth factors, antibodies, immunoassays, biologically active small molecule compounds, tissue culture reagents, T-Cell activation and gene editing technologies. Bio-Techne's product portfolio also includes protein analysis solutions, sold under the ProteinSimple brand name, offering researchers efficient and streamlined options for automated Western blot and multiplexed ELISA workflow. These reagent and protein analysis solutions are sold to biomedical researchers as well as clinical research laboratories and constitute the Protein Sciences Segment. Bio-Techne also develops and manufactures diagnostic products including FDA-regulated controls, calibrators, blood gas and clinical chemistry controls and custom assay development on dedicated clinical instruments. Bio-Techne's genomic tools include advanced tissue-based in situ hybridization assays (ISH) for research and clinical use, sold under the ACD brand as well as a portfolio of clinical molecular diagnostic oncology assays, including the ExoDx® Prostate test for prostate cancer diagnosis. These diagnostic and genomic products comprise Bio-Techne's Diagnostics and Genomics Segment. Bio-Techne products are integral components of scientific investigations into biological processes and molecular diagnostics, revealing the nature, diagnosis, etiology and progression 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 $714 million in net sales in fiscal 2019 and has over 2,200 employees worldwide.
About the Mount Sinai Health System
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 43,000 employees working across eight hospitals, over 400 outpatient practices, nearly 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.
Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes approximately 7,300 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report’s “Best Children’s Hospitals” ranks Mount Sinai Kravis Children's Hospital among the country’s best in several pediatric specialties.