Pune-based Mylab Discovery Solutions is the first Indian company to receive commercial approval for its novel coronavirus, or COVID-19, testing kits.
The testing kit has been approved by the Indian FDA/Central Drugs Standard Control Organisation (CDSCO), the molecular diagnostics company said in a release.
The move will help increase testing in India, where the number of samples being tested is still small.
One unit of the Mylab PathoDetect COVID-19 Qualitative PCR kit can test 1oo patients. The company said it can manufacture 1 lakh test kits a week, but can ramp up production if required.
"With emphasis on ‘Make in India’ and support from local and central government, the COVID- 19 kit, has been made as per WHO/CDC guidelines. It was developed and evaluated in a record time," Hasmukh Rawal, Managing Director, Mylab Discovery Solutions, said.
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Mylab, founded in 2016, describes itself as a "young and dynamic biotechnology company that develops and commercialises molecular diagnostic detection kits."
The company, which has 150 products, has experience in manufacturing ID-NAT screening kits for blood banks/hospitals, Quantitative HIV, HBV and HCV kits. It sells the ID-NAT screening kits under the brand name 'NATSpert'.
Mylab also manufactures diagnostic detection kits for determining an individual’s mutation status and offers products under the 'OncoScreen' brand name.
The company also has a portfolio of products for testing genetic disorders, called 'DiscoverSeries'.
"We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, agrigenomics and animal and food safety," the company said on its website.
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