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New Delhi: With the government now allowing accredited private labs to test for COVID-19, Roche Diagnostics India Tuesday received the test licence for SARS CoV-2 diagnostic test.

Meanwhile, two Indian diagnostic firms — Trivitron Healthcare and Mylab Discovery Solutions — have said they are still awaiting approvals from the Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organisation (CDSCO) for the coronavirus testing kits developed by them.

Roche Diagnostics India — Indian subsidiary of Swiss multinational firm Roche — has been accorded the test licence by the CDSCO.

A spokesperson of Roche Diagnostics India told ThePrint that the test had received the United States Food and Drug Administration (USFDA) Emergency Use Authorisation a few days earlier.

“The test license accorded to Roche Diagnostics India allows us to import select quantities of the cobas SARS Cov-2 diagnostic test for product performance evaluation. Following successful completion of the evaluation, a decision from the authorities will enable us to commercialise the kits in India,” he said.

“We would like to thank the CDSCO for providing us the test license in record time, as it enables Roche Diagnostics India to initiate the process of bringing a world class test to the country. Though this is the first step towards enabling access to the cobas SARS CoV-2 diagnostic test in India, it reinforces the Government’s intent to enable public-private partnership and improve patient access in a potentially serious healthcare situation,” the spokesperson added.

The kits developed by the three firms will be sold to private diagnostic chains such as Dr Lal Path Labs, SRL Diagnostics and Metropolis Healthcare, among others, to start community testing to detect the virus that has claimed three lives and infected 126 people in India so far.

The confirmatory reports for coronavirus tests will be given much faster once the private laboratories start testing. Going forward, the lab reports could be handed over to patients within two-and-a-half hours to five hours instead of the present turnaround time of two-three days.

Chennai-based medical device company Trivitron Healthcare is trying to reduce the turnaround time to three to five hours while Pune’s Mylab Discovery says it can generate results in just two-and-a-half hours.

Moreover, the capacity of testing can be jacked up by churning reports for 860 samples in eight hours on Roche’s kit. Other kits also promise more than 10,000 reports every day.

According to the World Health Organization (WHO), the diagnosis of COVID-19 must be confirmed by reverse transcription polymerase chain reaction (RT-PCR) or gene sequencing for respiratory or blood specimens. Currently, India is importing RT-PCR kits from Germany and Switzerland to test samples at 52 labs handled by the country’s apex health research body, ICMR.

ThePrint reached out to Drug Controller General of India V.G. Somani at CDSCO and Dr Balram Bhargava, Director General at ICMR, through text messages for a comment on the test kits developed by the three firms, but no reply had been received until the time of publishing. This report will be updated when they respond.

Also Read: New paper-based test developed by MIT researchers claims to detect coronavirus in 30 mins

‘Made in India’ kit by Mylab Discovery

The kits developed by the Pune-based firm are claimed to be completely made in India. “The kits will eliminate the requirement of two tests — screening and confirmatory testing. Rather, it will give the results within two-and-a-half hours of loading the samples on the machine,” Mylab Discovery managing director Hasmukh Rawal told ThePrint.

Dr Gautam Wankhede, director of medical affairs at Mylab, said, “Since the test is based on the sensitive PCR technology, even early stage infection can be detected with our kits. Per day, over 10,000 tests can be done and capacity can be increased.”

Mylab, in 2019, was recognised as India’s first FDA-approved molecular diagnostics company for the RT-PCR-based kits for testing HIV, Hepatitis B and C.

“With our expertise in the field of molecular diagnostics, the cost of testing will be much lesser with our kits in comparison to the foreign made kits. Their price of testing per sample is more than twice our price,” Wankhede said, without disclosing the price.

Mylab is the first company in Asia and second in the world to manufacture ID-NAT kits, which check blood samples to reduce risk of transfusion-transmitted infections in recipients.

Also Read: Why doctors in Italy are letting some coronavirus patients die to save others

Trivitron can produce 7.5 lakh kits every day

Trivitron Healthcare also calls its diagnostic test kits for COVID-19 the country’s first indigenous kit.

“The kit can be used in all five sample types recommended by ICMR and WHO. The costs are still being worked out. We have allocated Rs 4 to 5 crore emergency funds to upgrade our R&D infrastructure for launching hand sanitisers and COVID-19 kits,” Dr G.S.K. Velu, Chairman & Managing Director, Trivitron Healthcare Group, told ThePrint.

“The standard turnaround time is normally 2-3 days, but Trivitron is trying to reduce (the time) to 3-5 hours for generating results.”

“The kits by our joint venture company in China, Labsystems Diagnostics Shandong, are approved and sold there. China and we are planning to use that expertise and components to make them in India,” he said.

The company is waiting for approvals from the National Institute of Virology for validation protocols and positive samples. “In the next two to three weeks, as long as we complete our validation in government-approved institutions, 500 to 750,000 test kits can be produced per day.”

Roche says its kit will give results in 3 hrs

Roche, Swiss diagnostic and pharma giant, has received emergency use authorisation from the United States’ regulator Food and Drug Administration (FDA) for its SARS-CoV-2 test.

“Roche Diagnostics India is keen to partner with the Government’s efforts in their drive to manage the COVID-19 infection situation. We have the potential to offer 3 types of test kits that can be used to screen and further diagnose COVID-19 infections on our existing systems that run other infectious disease panels. These systems are installed across India’s 15 major cities,” Dr Shravan Subramanyam, Managing Director, India and Neighbouring Markets, Roche Diagnostics India Private Limited, told ThePrint in an email.

According to the company’s media release, the test kits — Roche’s cobas 6800/8800 Systems, which are used to perform the cobas SARS-CoV-2 Test — “provide test results in three and a half hours”.

The company also claims it provides up to 96 results in about three hours and a total of 384 results for the cobas 6800 System technology whereas 960 results are produced for the cobas 8800 System in eight hours.

Also Read: How coronavirus spread in India — 39 of the first 50 patients came from Italy, Iran, China

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