Benzinga | Oct 6, 2021 10:55AM EDT

Co-Diagnostics JV CoSara Receives Clearance from Indian Regulators for Dengue/Chikungunya Multiplex Test

Co-Diagnostics, Inc.(NASDAQ:CODX) (the "Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today 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(tm) Dengue and Chikungunya Multiplex RT-PCR test as an in vitro diagnostic ("IVD").

The CDSCO approval marks the 10th assay manufactured and sold by CoSara to receive clearance from the CDSCO, and follows the recent clearance of standalone dengue and chikungunya assays last month. In addition to those dengue and chikungunya assays and the new multiplex test, 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 designed using the Company's patented CoPrimer(tm) technology and cleared to be manufactured and sold as IVDs in the Indian market.

"We are pleased that this test built on our our highly-specific, patented CoPrimer technology has been approved to differentiate between these two mosquito-borne diseases which manifest in similar ways, and which have potential to greatly impact the communities and individuals afflicted by them," remarked Dwight Egan, Co-Diagnostics CEO.

CoSara Director Mohal Sarabhai commented, "Our growing menu of 'Make in India' diagnostics are designed to address the needs of the Indian healthcare market and the surrounding region. This new multiplex product makes a powerful addition to our suite of products that our representatives and distributors can offer to our expanding client base."

About half of the world's population is now at risk of a dengue infection following dramatic growth in recent decades, leading to an estimated 100-400 million infections each year according to the World Health Organization, with severe dengue a leading cause of hospitalization and death in affected regions. Chikungunya has been considered to have serious epidemic potential, due to its potential to cause considerable disability in a portion of the affected population.