CoSara Diagnostics gets CDSCO clearance for Hepatitis C Viral Load 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 from the Central Drugs Standard Control Organization (CDSCO) in India to manufacture and sell its SARAQ Hepatitis C ("HCV") Viral Load Kit as an in vitro diagnostic ("IVD").
CoSara's new real-time HCV PCR test is built on the Company's patented CoPrimer technology and designed to be used as an aid in assessing response to antiviral treatments in patients diagnosed with HCV, a disease with no effective vaccine that leads to nearly 300,000 deaths in 2019 according to the World Health Organization (WHO). Access to effective diagnosis and antiviral therapeutics is limited for the more than 1.5 million new chronic infections each year, and roughly 58 million people living with chronic HCV infection.
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