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Co-Diagnostics Joint Venture Gets Clearance in India for Five MDx Tests

NEW YORK – Co-Diagnostics' joint manufacturing venture, CoSara Diagnostics, has received regulatory clearance from the Central Drug Standard Control Organization in India for five in vitro diagnostic tests.

The five tests are molecular diagnostic assay kits, branded CoSara Saragene, are for the detection of tuberculosis, malaria, hepatitis B and hepatitis C viruses, and human papillomavirus. They can now be manufactured and sold from the CoSara facility in Ranoli, India.

The kits are for use on standard lab equipment, and the firm previously disclosed a price of $10 per test for its TB assay, which was created emphasizing targets specific to India.

Co-Diagnostics established the CoSara Diagnostics joint venture in 2017 with Synbiotics Limited, a subsidiary of a large pharmaceutical manufacturer called Asence Incorporated.

"India is soon to become the largest healthcare market on the planet and the best place for CoPrimer-powered products to be manufactured and distributed is from within the country itself," said Co-Diagnostics CEO Dwight Egan. "Being able to sell fully approved IVDs to this market represents the next stage in our growth as we establish Co-Diagnostics to be a leading innovator of high-quality, affordable diagnostics solutions," Egan added.

CoSara distributors have now begun taking pre-orders for the five IVDs, and Co-Diagnostics said it expects sales to ramp quickly. The joint venture has the exclusive manufacturing rights in India for the complete menu of Co-Diagnostics infectious disease molecular diagnostics kits, designed by Co-Diagnostics using their CoPrimer technology to reduce the formation of primer-dimers.

The joint venture also plans to submit tests to CDSCO for drug-resistant tuberculosis, HIV, and a multiplexed panel for blood-bank screening.