CDSCO nod to CoSara Diagnostics for manufacturing COVID-19 test with two target genes
The Saragene test kit approved by the CDSCO uses the Company's patented CoPrimer technology and is based on a test originally designed by Co Diagnostics, who also recently announced receipt of a CE marking for its Logix Smart SARS CoV 2 (genes RdRp/E) multiplex test.
New Delhi: Co-Diagnostics, Inc., 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 COVID-19 2-gene multiplex RT-PCR test as an in vitro diagnostic ("IVD"), intended for the qualitative detection of the SARS-CoV-2 virus.
The Saragene test kit approved by the CDSCO uses the Company's patented CoPrimer technology and is based on a test originally designed by Co-Diagnostics, who also recently announced receipt of a CE marking for its Logix Smart SARS-CoV-2 (genes RdRp/E) multiplex test. Both the CoSara and Co-Diagnostics test target two gene markers of the SARS-CoV-2 genome, RdRp and E-gene, to identify the presence of the virus, and were designed to meet the needs of those markets where government or regulatory bodies recommend a multi-target coronavirus diagnostic.
Dwight Egan, CEO of Co-Diagnostics, commented "Tests built on our CoPrimer technology have several advantages over other platforms, including the enhanced multiplex capabilities. We believe that the highly specific nature of the new Saragene test which follows World Health Organization guidance will help CoSara be able to play an even more active role in the battle against this pandemic."
CoSara Director Mohal Sarabhai remarked "Our honorable Prime Minister Shri Narendra Modi has endorsed the hike in number of available RT-PCR tests to keep the COVID-19 positivity rate under 5%. With this clearance in place, CoSara is geared up for this challenge by providing affordable, high quality, 'Made in India' 2-gene multiplex COVID-19 RT-PCR tests across the country."
CoSara has previously received CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C and human papillomavirus (HPV) to be manufactured and sold as IVDs in the Indian market.
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets a new, 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). The Company 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.