Co-Diagnostics’ Indian joint venture, CoSara Diagnostics, has received clearance from the Central Drugs Standard Control Organisation (CDSCO) for its Covid-19 test, Saragene COVID-19 2-gene multiplex RT-PCR test.
The latest development will allow CoSara to manufacture and sell its test as an in vitro diagnostic (IVD) for the qualitative detection of the SARS-CoV-2 virus.
The Saragene test kit, based on a test originally designed by the company, utilises Co-Diagnostics’ CoPrimer technology.
In February, Co-Diagnostics secured the regulatory CE Mark approval for its Logix Smart SARS-CoV-2 (genes RdRp / E) multiplex test.
To identify the virus presence, both the tests target two gene markers of the SARS-CoV-2 genome, RdRp and E-gene.
Co-Diagnostics CEO Dwight Egan 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.”
The tests are for those markets where the government or regulatory bodies prefer a multi-target coronavirus diagnostic.
CoSara Director Mohal Sarabhai said: “Our honourable 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.”
Earlier, CoSara obtained 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 India.