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In a landmark victory, an Indian company has been approved to manufacture and distribute testing kits for the COVID-19. Mylab Discovery Solutions Pvt. Ltd. is a Pune based molecular diagnostics company that developed the first Make-In-India COVID-19 testing kit on 25 March 2020. The testing kit is called Patho Detect, and has been manufactured under the leadership of virologist, Minal Dakhave Bhosle, the research and development chief of the lab.
Ms. Bhosle began working on it just days after leaving the hospital with a pregnancy complication in February - and managed to submit the kit for evaluation by the National Institute of Virology on March 18, just a day before she delivered her daughter. In an interview with the BBC, she said, “It was an emergency, so I took this on as a challenge. I have to serve my nation.”
The Indian government has been facing strong criticism for its low testing rates despite the scale of its population and the alarming speed at which the virus is spreading. While the FDA gave the nod to private companies to manufacture testing kits, a lot of them didn’t get approved due to their inefficiency in detecting the infection. Read more here.
What Is This Test?
The newly developed Reverse Transcription- Polymerase Chain Reaction testing kits have now been approved by the Indian FDA/ Central Drugs Standard Control Organisation (CDSCO). This is the first Made In India testing kit that has been developed in a record time of six weeks.
The Mylab PathoDetect COVID-19 Qualitative PCR kit screens and detects the infection within 2.5 hours, compared to the 7+ hours taken by current protocols.
How Many Tests Can They Manufacture?
Mylab has promised that it can manufacture up to 1 lakh tests in a week which can be further scaled up if needed. Further, the company claims that its test kits can test about 100 patients with one kit. An average lab with automated PCR can test more than 1000 patients a day.
How Much Does Each Test Cost?
Mylab test kits cost Rs 1,200 - a quarter of the cost of COVID-19 testing kits that India has been importing from abroad, and nearly one-third to one-fourth of the cost of the price cap provided by ICMR. But private and government labs approved by ICMR can conduct the tests for Covid-19. As of March 25, ICMR has approved more than 100 government labs and 29 private labs across the country for testing.
The company said it is ready to ship its first batch of testing kits today. These tests will be sent to Government and private testing labs approved by ICMR.
Read the full press release by Mylab Discovery Solutions Pvt. Ltd.
Feature Image Credit: Daily Express UK
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