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.
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