CoSara Diagnostics has secured clearance from the Indian Central Drugs Standard Control Organization (CDSCO) to manufacture and sell its Saragene COVID-19 2-gene multiplex RT-PCR test.
The approval allows the Saragene COVID-19 2-gene multiplex RT-PCR test to be used as an in vitro diagnostic (IVD) in the qualitative detection of the SARS-CoV-2 virus that causes Covid-19.
Mohal Sarabhai – CoSara Director said: “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 Diagnostics is a joint venture of American molecular diagnostics company Co-Diagnostics and India-based Ambalal Sarabhai Enterprises.
The approved Saragene Covid-19 test kit uses the CoPrimer technology of Co-Diagnostics, which also recently secured a CE marking for its Logix Smart SARS-CoV-2 (genes RdRp/E) multiplex test.
Both the Saragene and Logix Smart SARS-CoV-2 tests target a couple of gene markers of the SARS-CoV-2 genome, namely RdRp and E-gene for detecting the presence of the virus. The two tests have been designed by CoSara Diagnostics to address the needs of markets where the government or regulatory bodies recommend a multi-target coronavirus diagnostic.
Dwight Egan – CEO of Co-Diagnostics said: “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.”