CoSara Diagnostics gets CDSCO clearance for High-Risk HPV Multiplex Test
Salt Lake City: Co-Diagnostics, Inc., a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, has announced that CoSara Diagnostics Pvt Ltd, its joint venture for manufacturing and sales in India, has received clearance by the Central Drugs Standard Control Organization ("CDSCO") in India to manufacture and sell its SARAGENE Human Papillomavirus High-Risk (HPV-HR) Real-Time PCR test as an in vitro diagnostic ("IVD").
Human papillomavirus ("HPV") is the most common sexually transmissible infection in the world and the cause of almost all cervical cancer worldwide (the 4th deadliest cancer in women), as well as a substantial portion of certain other cancers, totaling over 600,000 cases of cancer per year being attributable to HPV. CoSara's new multiplex test, the 12th CoSara assay to receive CDSCO approval, is built on the Company's patented CoPrimer technology and designed to detect and differentiate between HPV genotypes 16 and 18, while simultaneously detecting high-risk carcinogenic HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.
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