Co-Diagnostics (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that its joint venture for manufacturing, CoSara Diagnostics Pvt Ltd, has obtained regulatory clearance for five tests to be manufactured and sold as in vitro diagnostics (“IVDs”) from its Ranoli, India-based facility. According to the update, the Saragene(TM) tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C and human papillomavirus (“HPV”) meet requirements of the Central Drug Standard Control Organization Medical Device Rules 2017, File no. 29/Misc./3/2017-DC (292), to be manufactured and sold as IVDs. “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,” Co-Diagnostics CEO Dwight Egan said in the news release. “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. We are excited to be taking this next step in our growth with such a distinguished partner and are eager to see returns on the time and effort we have spent to get to this point.”
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About Co-Diagnostics, Inc.
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets a new, state-of-the-art diagnostics technology. The company’s technology is utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The company also uses its proprietary technology to design specific tests to locate genetic markers for use in industries other than infectious disease and license the use of those tests to specific customers. For more information, visit the company’s website at www.CoDiagnostics.com.
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