Sunday, 14 August 2022

CoSara Diagnostics bags CDSCO clearance for high-risk HPV multiplex test

14 January 2022 | News

The multiplex test is built on the company's patented CoPrimer technology

Image Credit: Shutterstock

Image Credit: Shutterstock

Co-Diagnostics, a molecular diagnostics company, has announced that CoSara Diagnostics, its joint venture for manufacturing and sales in India, has received clearance by the Central Drugs Standard Control Organization (CDSCO) to manufacture and sell its SARAGENE Human Papillomavirus High-Risk (HPV-HR) Real-Time PCR test as an in vitro diagnostic (IVD).


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.


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.



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