India is now among the handful of nations that have developed their own Coronavirus test kits.
Pune-based molecular diagnostics company Mylab Discovery Solutions Pvt Ltd, which specialises in molecular diagnostic kits has developed first made-in-India test kit for COVID-19 in a record time of six weeks. The kit — Mylab PathoDetect COVID-19 Qualitative PCR kit — is the first one to receive commercial approval from the Indian FDA/ Central Drugs Standard Control Organisation (CDSCO). Besides, Mylab is the only Indian company to have achieved 100 per cent sensitivity and specificity in the ICMR evaluation.
“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. He further added that the support and the immediate action from regulatory bodies (CDSCO/FDA), evaluation centre of ICMR, NIV, Biotechnology Industry Research Assistance Council (BIRAC) and the central and state governments during this national emergency is commendable.
He further added that the support and the immediate action from regulatory bodies (CDSCO/FDA), evaluation centre of ICMR, NIV, Biotechnology Industry Research Assistance Council (BIRAC) and the central and state governments during this national emergency is commendable.
“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 at Mylab.
Higher levels of testing is crucial to preventing the spread of the coronavirus epidemic — countries like South Korea have managed to arrest the spread of the virus through aggressive testing through their indigenously developed kits. Thus far, the Indian government had been sourcing millions of testing kits from Germany to facilitate testing to diagnose Coronavirus patients PAN-India. However, the dependency on foreign kits had been troublesome and supply is getting blocked due to grounded airlines.
Made in India kits, like the one made by Mylab, will help solve the problem. The Mylab kit will cost one fourth of kits being currently procured from abroad, and detects the infection within 2.5 hours, compared to seven-plus hours taken by current protocols. Mylab says it can manufacture up to 1 lakh tests in a week that can be further scaled up if needed. Further, the company claims that its test kits can test about 100 patients with one kit.