Testing kits made by Pune-based Mylab expected to be priced at Rs 1,200; receive commercial approval from Indian FDA/ Central Drugs Standard Control Organisation
New Delhi: In a record time of six weeks, Pune-based molecular diagnostics company Mylab Discovery Solutions has developed the first made-in-India test kit for COVID-19.
The kit, called Mylab PathoDetect COVID-19 Qualitative PCR kit, is the first to receive commercial approval from the Indian FDA/ Central Drugs Standard Control Organisation (CDSCO).
Mylab, which specialises in molecular diagnostic kits, is the only Indian company to have achieved 100% sensitivity and specificity in the ICMR evaluation.
Hasmukh Rawal, managing director, Mylab Discovery Solutions, said that the kits have been made as per the guidelines of WHO/CDC guidelines with emphasis on 'Make in India' and support from local and central government. He also lauded the support and prompt action from regulatory bodies and the governments.
The Mylab COVID-19 kit had been evaluated at the Indian Council of Medical Research (ICMR).
"We have been trying hard to make cutting edge technology available to our country at a reasonable and affordable price. Since this test is based on the sensitive PCR technology, even early-stage infection can be detected, with highest accuracy as has been seen during tests at ICMR. The ICMR tested, CDSCO approved kit makes detection faster too," said Shailendra Kawade, executive director of Mylab.
The kits, expected to be priced at Rs 1,200 approximately, are expected to boost the testing capacity of the country. So far, the country has been sourcing millions of testing kits from Germany to facilitate testing to diagnose coronavirus patients across India.
The company is likely to produce one lakh test kits per week and then gradually increase the production to meet the testing demands. 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 1,000 patients a day.