Roche Diagnostics India has initiated the process to bring in its high-volume diagnostic tests that detect the novel coronavirus (COVID-19), said Managing Director Shravan Subramanyam.

However, some constraints, including supply-related bottlenecks, have to be addressed, he said, as the global demand for testing has surged with increase in the incidence of people affected by the Covid-19 virus.

The Swiss company’s move comes just days after Roche’s cobas SARS Cov-2 diagnostic test received an Emergency Use Authorisation (a green signal for use during the crisis period) from the US Food and Drug Administration. This is the first commercially distributed diagnostic test to receive an EUA during the COVID-19 outbreak, the FDA said, as the authorisation was given within 24 hours of receiving its application.

Need for validation

The company is in the process of getting an import licence on these tests, Subramanyam told BusinessLine , even as the Indian Council of Medical Research (ICMR) announced it was scaling up its labs and roping in private players to test more people. Armed now with a “test licence” in India from the Central Drugs Standard Control Organisation (CDSCO), he said, Roche would look to bring in its tests for both research and commercial purposes.

But first, the tests would have to go through a performance evaluation or “validation” by Pune’s National Institute of Virology, he added.

The second constraint was to make these tests available in as many government and private labs across the country, Subramanyam said. And the third challenge was for the industry to meet supplies across the world.

These high-volume test systems were fully automated, and provided test results in three-and-a-half hours, about half the time taken otherwise, said a company representative. About 1,400 samples can be tested in a day, the representative added. The existing systems handle about 90 samples in a day presently, said an ICMR representative.

Supply and price concerns

Against the backdrop of an increased global demand, Subramanyam said the manufacture and supply were being ramped up and the allocation would be done ‘equitably’. But there were manufacturing bottlenecks, he admitted, adding that they were assessing the quantity that could be supplied once local approvals come in.

The reagent used for testing the sample would be imported from the US, a company representative said. No details on prices were given on the hardware and reagent used to test the samples. both components, Subramanyam cited the example of HIV-related tests and added that the pricing was usually “close to what makes sense for the market”.

Responding to concerns across the world on the cost of tests, he said, the reagents would be a recurring cost for labs, but increased volumes would bring in economies of scale. Calling for greater private sector participation in the efforts to tackle the virus, he said, various funding mechanisms needed to be followed to make the products accessible.

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