Swiss pharmaceutical major Roche, which received the Emergency Use Authorisation for its novel coronavirus diagnostic test - Cobas SARS-CoV-2 Test - from US Food and Drug Administration on March 12, will soon make it available in India.
The test detects the genetic signature (RNA) of the SARS-CoV-2 virus, also known as novel coronavirus or COVID-19, in swab samples that a healthcare provider collects from the back of the patient's throat or nose, states Roche's website. It also says that the company expects to supply about 400,000 tests per week in the US, making it one of the sought after tests in that country.
Roche's Indian subsidiary - Roche Diagnostics India Pvt Ltd - has received conditional import licence from the Central Drugs Standard Control Organisation (CDSCO) and is in the process of importing the test kits, a company spokesperson said.
The Cobas SARS CoV-2 assay, a real-time PCR molecular offering, is also CE-IVD certified, the requisite approved needed to market the product in Europe. Given the increasing need to make more COVID-19 diagnostic kits available in the country, the central government had fast-tracked the regulatory approval process by allowing US FDA EUA/CE IVD approved kits to be used directly after due approval from DCGI and intimation to ICMR without any further validation within India.
The Roche India spokesperson said the Cobas SARS CoV-2 test is likely to be made available for patient testing in India over the next few weeks.
Meanwhile, the Indian Council of Medical Research (ICMR) has established a fast-track mechanism for validation of non-US FDA EUA/CE IVD approved kits at four of its constituent laboratories.
Pune-based National Institute of Virology (NIV) and National Aids Research Institute, National Institute of Pathology, New Delhi, and National Institute of Cholera and Enteric Diseases (NICED), Kolkata, can thus evaluate test kits for 100 per cent concordance among true positive and true negative samples and recommend it for commercial use in India. As on March 28, four kit makers, including an Indian firm, got marketing approval for their COVID-19 PCR based molecular diagnostic testing.
Roche's three Research Use Only (RUO) kits test kits were also submitted for evaluation under ICMR's fast track window. However, the kits - LightMix Modular SARS and Wuhan CoV E gene, LightMix Modular SARS and Wuhan CoV N gene and LightMix Modular Wuhan RdRp gene - are yet to be approved. The spokesperson said the "the three COVID-19 tests mentioned under Roche in the ICMR list are Research Use Only (RUO) kits that respectively provide screening and confirmatory tests. They have yet not been approved for patient testing".