Co-Diagnostics JV CoSara Receives Clearance from Indian Regulators for ABC Multiplex Test

December 7, 2021

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 SARAPLEX™ Flu A/Flu B/COVID-19 (ABC) RT-PCR test as an in vitro diagnostic (“IVD”).

CoSara’s new test, the 4^th CoSara assay to receive CDSCO approval this year and 11^th overall, is built on the Company’s patented CoPrimer™ technology and designed for the simultaneous detection and differentiation of influenza A, influenza B, and SARS-CoV-2. As with earlier CoSara tests that detect the disease that causes COVID-19, the SARS-CoV-2 targets in the test remain effective in detecting all known strains of the virus, including the Omicron variant.

Co-Diagnostics CEO Dwight Egan commented “As we continue to see variants arise and spread across the world, it has never been more important to have access to reliable, accurate, and affordable diagnostics as the first line of defense, and we are pleased about the role our CoPrimer technology is playing across the world to help increase this availability.”

“With several million cases of severe flu infections every year, and with such similar symptoms to the ever-mutating COVID-19, accurately detecting and distinguishing between these diseases will play a vital role in bolstering the global healthcare response to respiratory illnesses,” remarked CoSara Director Mohal Sarabhai. “We are excited to be able to provide additional tools to our growing client base to assist in these efforts in accordance with the ‘Make in India‘ initiative and to address the needs of the Indian market and the surrounding region.”

CoSara has previously received CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C, human papillomavirus (HPV), two COVID-19 assays, chikungunya, dengue, and a dengue/chikungunya duplex test, all designed using the Company’s patented CoPrimer technology and cleared to be manufactured and sold as IVDs in the Indian market.

About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets a 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.