Pune-based molecular diagnostics company Mylab DiscoverySolutions has developed the first made in India test kit for COVID-19 in arecord time of six weeks.
The testing kit is the first one to receive commercial approval from the Indian FDA/ Central Drugs Standard Control Organisation (CDSCO) and is named as Mylab PathoDetect COVID-19 Qualitative PCR kit. Mylab is the only Indian company to have achieved 100 percent sensitivity and 100 percent specificity in the ICMR evaluation.
Hasmukh Rawal, Managing Director, Mylab Discovery Solutions, said, "With the 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. The support and the immediate action from regulatory bodies (CDSCO/FDA), evaluation center of ICMR, NIV, Biotechnology Industry Research Assistance Council (BIRAC) and the central and state governments during this national emergency is commendable".
The Mylab COVID-19 kit has been evaluated at the Indian Council of Medical Research (ICMR).
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.
