17 September 2021 | News
The company will be able to sell its Saragene dengue and chikungunya RT-PCR tests
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US-based Co-Diagnostics 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) in India to manufacture and sell its Saragene dengue and chikungunya RT-PCR tests as in vitro diagnostics (IVD).
The Saragene test kits approved by the CDSCO use the company's patented CoPrimer technology for the qualitative detection of these mosquito-borne viruses.
Mohal Sarabhai, Director, CoSara remarked, "We are pleased to be able to add two more products to our menu of diagnostics that can all be manufactured in India in agreement with the 'Make in India' initiative, as well as exported to help serve the needs of this region of the world which is highly burdened by the effects of these two diseases."
Dwight Egan, CEO, Co-Diagnostics, commented, "The first step in effective treatment of infectious diseases is an accurate diagnosis. Our highly specific CoPrimer technology is ideally suited to distinguish between similar diseases like dengue and chikungunya, and we believe that these tests have the potential to improve the lives of infected patients through more accessible and accurate diagnoses leading to better treatment."
CoSara has previously received CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C, human papillomavirus (HPV), and two COVID-19 assays, all to be manufactured and sold as IVDs in the Indian market.