Co-Diagnostics, Inc. JV CoSara Receives Clearance from Indian Regulators for High-Risk HPV Multiplex Test

January 13, 2022

Co-Diagnostics, Inc. 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 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 4^thdeadliest 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 12^th 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.

“The multiplexing capabilities of cutting-edge CoPrimer technology make it an ideal platform for such an important diagnostic and screening tool as this test for HPV-HR, marking an expansion in the breadth of tests built on this platform for endemic diseases around the world,” remarked Dwight Egan, Co-Diagnostics CEO. “We believe that the first step in reducing transmission in those less developed areas where HPV vaccination rates remain low is affordable, high-quality diagnostic tools, and we are pleased about the role that Co-Diagnostics technology will be playing in helping to increase the accessibility of such products.”

CoSara Director Mohal Sarabhai commented, “Despite the existence of safe, effective vaccines for HPV, the burden of HPV-related cancer and disease remains high. The World Health Organization has also stated that HPV is the most common viral infection of the reproductive tract and that most sexually active women and men will be infected at some point in their lives. HPV-HR has been one of the most in-demand tests among our distributor and customer base, and we are excited to be able to now offer this diagnostic tool in accordance with the ‘Make in India‘ initiative for India and the surrounding region, where limited access to vaccines remains an ongoing struggle.”

CoSara has previously received CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C, HPV (types 16 and 18 only), 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.