Mount Sinai Health System ("Mount Sinai") and Renalytix AI (LSE: RENX) today announced the formation of Kantaro Biosciences, LLC ("Kantaro"), a Mount Sinai venture, to develop and scale production and distribution of a test kit based on the Mount Sinai-developed high-performance serologic assay for SARS-CoV-2 antibodies.
Kantaro has partnered with Minneapolis-based Bio-Techne Corporation (NASDAQ: TECH) to develop and launch the new kit, with the goal of producing more than ten million patient tests per month by July.
The two companies have formed a joint commercialization and distribution team to support the rapid distribution of kits to clinical laboratories in the US and around the world.
Kantaro's SARS-CoV-2 test kits are designed for use in any authorized clinical testing laboratory without the need for proprietary equipment.
The technology underlying the kits was created by a team of internationally recognized scientists and clinicians, including members from the Departments of Microbiology and Pathology, Molecular and Cell-Based Medicine within the Icahn School of Medicine at Mount Sinai.
The original Mount Sinai test was validated in The Mount Sinai Hospital's Clinical Laboratories, and has been performed on over 30,000 patient samples.
The Kantaro test kit, an enzyme-linked immunosorbent assay (ELISA), builds on this test technology and 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.
The kit will utilize not one, but two virus antigens, the full-length spike protein, and its receptor binding domain, necessary for viral entry into cells.
Mount Sinai developed the underlying assay in response to the critical needs of thousands of patients within the hospital system, including those who were severely ill and could potentially benefit from convalescent plasma for emergency therapy.
Mount Sinai was issued an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for clinical testing in its CLIA certified laboratory on April 15th. Kantaro plans to seek EUA for the test kit following final validation.
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."
Florian Krammer, PhD and Professor of Microbiology, Icahn School of Medicine
"With the launch of Kantaro, we look forward to bringing a kit based on our highly specific and sensitive test to every corner of the globe." The serological assay developed by Dr. Krammer and colleauges for the screening and identification of human SARS-CoV-2 seroconverters was described in a paper published in Nature Medicine on May 12, 2020.
"We believe that this technology has the potential for providing insight into immunity, and we're working intensely to develop a quantitative version," said 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.
"We expect that future findings will be critical to vaccine development and the development of advanced therapeutics." Due to the large number of COVID-19 patients who have been treated at Mount Sinai, with over 5,000 patients returning home to date, the Mount Sinai technology has been utilized across a large and highly diverse population.
"This technology reflects our commitment to everyone affected by SARS-CoV-2 and to developing tools for effectively combatting this disease," said Erik Lium, PhD, Executive Vice President and Chief Commercial Innovation Officer at Mount Sinai.
"We believe that the rapid development, scaleup and distribution of these kits, based on the highly accurate Mount Sinai assay, can be a cornerstone in the global battle against COVID-19."