The approval allows to manufacture and sell the test as an in vitro diagnostic or the qualitative detection of the SARS-CoV-2 virus
CoSara Diagnostics, a joint venture (JV) of Co-Diagnostics, has secured clearance from the India’s Central Drugs Standard Control Organisation (CDSCO) for its Saragene Covid-19 2-gene multiplex reverse transcription-polymerase chain reaction (RT-PCR) test.
The approval allows to manufacture and sell Saragene Covid-19 2-gene multiplex RT-PCR as an in vitro diagnostic test for the qualitative detection of the SARS-CoV-2 virus.
The Saragene test kit uses the patented CoPrimer technology and is based on a test originally developed by Co-Diagnostics.
Recently, Co-Diagnostics has also secured CE mark approval for its Logix Smart SARS-CoV-2 (genes RdRp/E) multiplex test.
CoSara and Co-Diagnostics tests target two gene markers of SARS-CoV-2 genome
To detect the presence of the virus, both the CoSara and Co-Diagnostics test target two gene markers of the SARS-CoV-2 genome, RdRp and E-gene.
According to the company, the tests have been designed to meet the requirements of the markets where government or regulatory bodies recommend a multi-target coronavirus diagnostic.
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.”
Earlier, CoSara secured CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C and human papillomavirus (HPV) to manufacture and sell as IVDs in the Indian market.
In February this year, Co-Diagnostics introduced its CoPrimer test for the 2019-nCoV coronavirus or Covid-19 virus.
The research use only (RUO) test is developed for use by appropriate laboratories, hospitals, and institutions to address the current coronavirus epidemic.