Bio-Techne Corporation and the Mount Sinai Health System in New York, through its commercial affiliate Kantaro Biosciences LLC (Kantaro), today announced a partnership to initiate scaled manufacturing and distribution of testing kits based on the Mount Sinai-developed COVID-19 serology test. Kantaro Biosciences is a joint venture between Mount Sinai Health System ("Mount Sinai") and Renalytix AI (LSE: RENX) formed exclusively to ensure that diagnostic tests for critical health challenges are accessible to all.
The Mount Sinai COVID-19 serology test was one of the first widely published serology tests in the United States and has gained recognition as a trusted, high-performing assay and comparator for subsequent COVID-19 serology tests. Kantaro has partnered with Bio-Techne to develop a test kit based on the Mount Sinai test and to scale up, manufacture, sell and distribute these kits. Initial kit production capacity is expected to enable laboratories to conduct in excess of 10 million tests monthly in July, scaling to higher capacity in subsequent months. The two companies have formed a joint commercialization and distribution team to support rapid distribution of the assay.
Mount Sinai was issued an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for clinical testing in its CLIA certified laboratory on April 15th. Based on this success, Bio-Techne and Mount Sinai have partnered to develop high-quality production test kits, based upon the Mount Sinai test, which can be manufactured and distributed globally at scale. Kantaro will lead regulatory processes with the intention of submitting the scaled assay for FDA EUA review in May. Kit shipments are expected to begin immediately following the receipt of FDA regulatory authorization.
The IgG antibody test kit, an enzyme-linked immunosorbent assay or ELISA, is designed to measure the presence or absence of anti-COVID-19 antibodies in addition to measuring the titer (level) of antibodies a person has produced. It utilizes not one, but two virus antigens, the full-length Spike protein, and its Receptor Binding Domain, which is necessary for viral entry into cells, and is potentially linked with neutralization. The test kit will use a simple patient blood draw and is designed to be easily run by any laboratory in the world without costly proprietary equipment. The technology underlying the diagnostic test was created by internationally recognized virology and pathology teams from the Icahn School of Medicine at Mount Sinai.
In a recent comparison of EUA tests published by the FDA (link), which assumed a 5% incidence of COVID-19 in the population, the "Mount Sinai Hospital Clinical Laboratory COVID-19 ELISA Antibody Test" was reported to show a Positive Predictive Value (the probability of disease if the test is positive) of 100% and a Negative Predictive Value (the probability of no disease if the test is negative) of 99.6%. Bio-Techne and Kantaro are in the process of validating the scaled assay and expect the data to confirm similar results.
Combining Mount Sinai's strengths in disease management, patient monitoring and clinical study design with Bio-Techne's capabilities as a fully integrated, world leading ELISA developer and manufacturer, allows us to co-develop and validate what we believe will be the highest quality and highest utility assay for COVID-19 in the world. The assay not only identifies individuals with prior exposure to the COVID-19 virus; the two step test is designed to minimize false negative and false positive results while delivering valuable, quantitative information regarding the immunity state of previously infected people."
Dave Eansor, President, Bio-Techne's Protein Sciences Segment
We are extremely excited to partner with Kantaro and Mount Sinai to launch what we believe will be a gold standard serology test for COVID-19. The Bio-Techne, Mount Sinai and Kantaro teams are working around the clock to develop this test, and we are on track to achieve in approximately eight weeks what would typically take 18 months or more. As the world leader in ELISA assays, Bio-Techne has substantial capacity and the ability to scale production levels to support much of our nation's needs. We look forward to providing the world with critical information related to past exposure to the virus."
Chuck Kummeth, President and Chief Executive Officer, Bio-Techne
Antibody testing will be critical to providing patients and governments the essential information they need to help the world economies reopen and begin to recover from COVID-19. Through Kantaro's partnership with Bio-Techne, we look forward to bringing this extremely high-quality test to every corner of the globe, so that COVID-19 can be monitored and isolated."
Florian Krammer, PhD, Professor of Microbiology, Icahn School of Medicine
The original Mount Sinai assay has been performed on more than 30,000 patient samples. Mount Sinai is studying the use of the technology to measure antibody titer in previously infected individuals, to support vaccine development, and to help evaluate emerging immunotherapies.