Roche gets ICMR approval for COVID-19 antibody test
The Roche Elecsys Anti-SARS-CoV-2 serology test that supports the detection of antibodies against SARS-CoV- 2 has received the Import License issued by the Central Drug Standard Control Organization (CDSCO), due to the emergency health situation in the public interest.
New Delhi: Roche Diagnostics India recently said it welcomed the Indian Council of Medical Research's (ICMR) approval to carry out the COVID-19 antibody test for seroprevalence studies in India.
The Roche Elecsys Anti-SARS-CoV-2 serology test that supports the detection of antibodies against SARS-CoV- 2 has received the Import License issued by the Central Drug Standard Control Organization (CDSCO), due to the emergency health situation in the public interest.
The test is CE IVD certified and has received USFDA emergency use authorization (EUA). Roche's world-class COVID-19 antibody test is already deployed in the UK, Singapore, and other countries to test for COVID-19 antibodies.
"Roche Diagnostics India welcomes ICMR's communication that cites making available Roche COVID-19 antibody test for seroprevalence studies in India - including those on high-risk groups like healthcare workers - to plan the country's pandemic management efforts in the future," said Dr. Shravan Subramanyam, Roche Diagnostics India.
"Roche's lab-based antibody test that runs on fully automated CLIA analyzers with estimated peak testing capacity of 0.5 million tests a day is being made available across NABL approved and Government sites in India," he added.
We are committed to explore public-private partnerships to build scale and thereby access to Roche COVID- 19 antibody tests in India, he further added.
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