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Bio-Techne, Kantaro Biosciences to Develop, Scale Production of Mount Sinai Coronavirus Test

NEW YORK ─ Bio-Techne and Mount Sinai Health System on Tuesday announced a partnership to initiate further development, scaled manufacturing, and distribution of a Mount Sinai-developed serology testing kit for the coronavirus that causes COVID-19.

As part of the deal, life sciences firm Bio-Techne will collaborate with Kantaro Biosciences, a joint venture of New York-based Mount Sinai and Renalytix AI, a London-based developer of artificial intelligence-based in vitro diagnostic products for kidney disease.

Financial and other terms of the partnership were not disclosed.

In April, Mount Sinai received an Emergency Use Authorization for its serology assay, called the COVID-19 ELISA IgG Antibody Test, from the US Food and Drug Administration for clinical testing in its CLIA-certified laboratory. The assay has been performed on more than 30,000 patient samples.

Under the terms of the partnership, Kantaro and Bio-Techne will develop, scale up, manufacture, sell, and distribute a kit based on the Mount Sinai assay. Kantaro will lead regulatory processes with the intention of submitting the scaled assay for an FDA EUA review in May. The firms expect to begin shipping kits right away if they receive the FDA EUA.

Initial production is expected to enable labs to conduct more than 10 million tests per month in July, Bio-Techne and Mount Sinai said. The partners anticipate scaling to higher capacity in subsequent months, and they have formed a joint commercialization and distribution team to support rapid distribution of the assay.

The IgG antibody test kit is an enzyme-linked immunosorbent assay (ELISA) that uses a blood draw to measure the presence or absence of anti-COVID-19 antibodies and measure the level of antibodies a person has produced. The kit uses two virus antigens and the full-length spike protein as well as its receptor binding domain, which is necessary for viral entry into cells and is potentially linked with neutralization, the firms said.

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 of Bio-Techne's protein sciences segment, said in a statement.

Citing a recent comparison of tests that have received EUAs, which was published by the FDA, the firms noted that the Mount Sinai test showed a positive predictive value of 100 percent and a negative predictive value of 99.6 percent. The comparison assumed a 5 percent incidence of COVID-19 in the population. Kantaro and Minneapolis, Minnesota-based Bio-Techne said that they expect validation data for the scaled assay to be similar.

The technology underlying the diagnostic test was developed by virology and pathology teams from the Icahn School of Medicine at Mount Sinai.

Mount Sinai is studying the use of the technology to measure antibody levels in previously infected individuals to support vaccine development and to help evaluate emerging immunotherapies.