Pune-based molecular diagnostics company Mylab Discovery Solutions has become the first company in the country to receive approval from Indian FDA or Central Drugs Standard Control Organisation (CDSCO) for its coronavirus (Covid-19) diagnostic test kits.
According to the company, the reverse transcription polymerase chain reaction (RT-PCR) test kits can study 1000 samples from large labs and 200 from smaller labs.
“With emphasis on ‘Make in India’ and support from local and Central government, the COVID- 19 kit has been made as per WHO or CDC guidelines. It was developed and evaluated in a record time,” Hasmukh Rawal, managing director of Mylab Discovery Solutions said.
Mylab expects to produce one lakh test kits every week and then gradually increase the production to meet the testing demands. The local sourcing of test kits will be a major breakthrough for India as the testing kit by Mylab would cost nearly one-fourth of the current procurement cost, the company said.
Moreover, Mylab is the only Indian company to have achieved 100% sensitivity and specificity in the ICMR evaluation.
Dr Gautam Wankhde, medical director of Mylab said, “In the current lab-based testing, it takes four hours for test results to come out, Mylab’s turnaround time is two and half hours.”
The approximate cost for these kits would be around Rs 1200.
The Drug Controller General of India (DCGI) has granted a test licence to 14 private companies, including Roche Diagnostics India, to evaluate the quality of testing kits for detecting Covid-19.