On May 19, 2020, Bio-Techne and the Mount Sinai Health System in New York, through its commercial affiliate Kantaro Biosciences, 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 and Renalytix AI 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 15^th.  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, 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.

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.

Bio-Techne 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 $714 million in net sales in fiscal 2019 and has over 2,200 employees worldwide