Co-Diagnostics (NASDAQ:CODX) Inc, has announced that CoSara Diagnostics Pvt Ltd, its joint venture for manufacturing and sales in India, has received clearance from the Central Drugs Standard Control Organization (CDSCO) in India to manufacture and sell its SARAPLEX Flu A/Flu B/coronavirus (COVID-19) RTPCR test as an in vitro diagnostic (IVD).
The Salt Lake City, Utah-based molecular diagnostics company noted that CoSara's new test, the fourth CoSara assay to receive CDSCO approval this year and 11th 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 (ABC).
As with earlier CoSara tests that detect the disease that causes COVID-19, the company said the SARS-CoV-2 targets in the test remain effective in detecting all known strains of the virus, including the new Omicron variant.
READ: Co-Diagnostics says its suite of coronavirus diagnostics not affected by heavily mutated Omicron variant
"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,” Co-Diagnostics (NASDAQ:CODX) CEO Dwight Egan said in a statement.
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.
"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."
Co-Diagnostics (NASDAQ:CODX) 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).
It 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.
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