Kantaro, a commercial affiliate of the Mount Sinai Health System in New York, will collaborate with Bio-Techne to develop a test kit based on the Mount Sinai-developed coronavirus test and scale the manufacturing and distribution of those kits. The companies formed a joint commercialization and distribution team to support the rapid distribution of the assay.
Initial kit production capacity is expected to allow laboratories to conduct more than 10 million tests monthly, starting in July and scaling to higher capacity in the following months.
Mount Sinai’s test kit, which received FDA emergency use authorization (EUA) in April, is an enzyme-linked immunosorbent assay (ELISA) for measuring the presence or absence of anti-COVID-19 antibodies and the level of antibodies a person has produced. It uses a blood-draw designed for easy use in any laboratory around the world.
“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,” Bio-Techne protein sciences segment president Dave Eansor said in a news release. “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.”
The partnership will see Kantaro lead regulatory efforts as the companies intend to submit the new scaled assay for FDA EUA review this month. They plan to ship kits immediately after receiving FDA authorization.
“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,” added Bio-Techne president & CEO Chuck Kummeth. “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.”