CoSara Diagnostics gets CDSCO clearance for chikungunya, dengue tests
Salt Lake City: Co-Diagnostics, Inc. has recently announced that CoSara Diagnostics Pvt Ltd, 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.
According to the World Health Organization, the global incidence of dengue has grown dramatically in recent decades to become a leading cause of death in some Asian and Latin American countries, with 70% of the burden in Asia despite a risk of infection existing in 129 countries. About half of the world's population is now at risk, leading to an estimated 100-400 million infections each year.
While less lethal than dengue, chikungunya has been considered by the WHO to have serious epidemic potential, due to its potential to cause considerable disability in a proportion of the affected population and ultimately substantial socioeconomic impact in those areas.
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