Co-Diagnostics, Inc., a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced that CoSara Diagnostics Pvt Ltd (“CoSara,” or the “JV”), 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 SARAQ™ Hepatitis C (“HCV”) Viral Load Kit as an in vitro diagnostic (“IVD”).
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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.
Dwight Egan, Co-Diagnostics CEO, commented “The enduring market for HCV diagnostics is a result of the persistent spread of the disease and highlights the importance of providing accurate, affordable PCR testing solutions on a global level, especially to those regions where the disease burden is highest. We are pleased that our CoPrimer technology will play a significant role in helping to reduce this burden in India and the surrounding areas.”
CoSara Director Mohal Sarabhai remarked, “The approval of this important test marks the 14th IVD to receive clearance by the CDSCO, and strengthens our foundation for future growth. Effective HCV treatments are especially useful when used in tandem with tests for diagnosing and monitoring those therapies. This HCV Viral Load kit test adds to our expanding menu of valuable diagnostic tools available to our growing distributor and laboratory customer base.”
CoSara has previously received CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis B viral load, hepatitis C, HPV types 16 and 18 and HPV-HR, two COVID-19 assays, chikungunya, dengue, a dengue/chikungunya duplex test, and a Flu A/Flu B/COVID-19 (“ABC”) multiplex test, all designed using the Company’s patented CoPrimer technology and cleared to be manufactured and sold as IVDs in the Indian market.