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March 24, 2020

Mylab receives approval for Covid-19 test kit

India-based Mylab Discovery has become the first company in the country to receive approval for its coronavirus (Covid-19) diagnostic test kits, called reverse transcription polymerase chain reaction (RT-PCR) tests.


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India-based Mylab Discovery has become the first company in the country to receive approval for its coronavirus (Covid-19) diagnostic test kits, called reverse transcription polymerase chain reaction (RT-PCR) tests.

The testing kit has been commercially approved by the Indian FDA / Central Drugs Standard Control Organisation (CDSCO).

The approval is expected to help increase testing in the country.

RT-PCR kits can study 1000 samples from large labs and 200 from smaller labs.

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Mylab expects to produce one lakh test kits per week and then gradually increase the production to meet the testing demands.

Mylab medical director Dr Gautam Wankhde said: “In the current lab-based testing, it takes four years for test results to come out, Mylab’s turnaround time is two and half hours.”

The kits are expected to be priced approximately INR1200.

Germany’s Altona Diagnostics has also won approval for its diagnostic kit for coronavirus.

Last week, the Drug Controller General of India (DCGI) granted a test licence to 14 private companies, including Roche Diagnostics India, to evaluate the quality of testing kits for detecting Covid-19.

Meanwhile, India is experiencing a rise in coronavirus cases. So far, 511 positive cases and nine deaths have been recorded. Most of the cases are reported in Kerala.

The Indian Government is putting strict measures in place to reduce the spread of the virus. It has ordered all states in the country to impose lockdown.

This disease was first reported in Wuhan, China.

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