The kit received commercial approval from Indian FDA/ Central Drugs Standard Control Organisation and is named as Mylab PathoDetect COVID-19 Qualitative PCR kit
As India fights back the epidemic COVID-19, limited testing facilities and expensive testing kits has become the biggest concern for the authorities. In order to combat this challenge, Pune-based molecular diagnostics company Mylab Discovery Solutions has developed the first made in India test kit for COVID-19 in a record time of six weeks. The kit is the first one to receive commercial approval from Indian FDA/ Central Drugs Standard Control Organisation (CDSCO) and is named as Mylab PathoDetect COVID-19 Qualitative PCR kit. Further, Mylab is the only Indian company to have achieved 100 per cent sensitivity and 100 per cent specificity in the ICMR evaluation.
Hasmukh Rawal, Managing Director, Mylab Discovery Solutions, said, “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”. 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.
Mylab currently manufactures ID-NAT screening kits for blood banks/hospitals, Quantitative HIV, HBV and HCV kits. Apart from this, Mylab has received clearance from Drugs Controller General of India (DCGI) to manufacture the COVID-19 Qualitative kit, in the same facility. The Mylab COVID-19 kit has been evaluated at 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, Mylab.
Mylab promised that it can manufacture up to one 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.
With local sourcing of test kits it will be a major breakthrough for India as the testing kit by Mylab would cost nearly one fourth of the current procurement cost. Moreover, Mylab PathoDetect COVID-19 Qualitative PCR kit screens and detects the infection within 2.5 hours, compared to 7+ hours taken by current protocols. This means that laboratories will be able to do twice the number of reactions in the same time on one machine.
The Mylab manufacturing facility, approved by FDA/CDSCO is compliant with MDR 2017 regulation for Manufacturing Medical Device of Class A,B,C and D and ISO 13485: 2016 certification.