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It is a proud time for India as the Made-In-India test kit for COVID-19 has been developed in a record time of six weeks by Mylab Discovery Solutions Pvt Ltd. Those who do not know, Mylab Discovery Solutions Pvt Ltd is a Pune-based molecular diagnostics company which specializes in molecular diagnostic kits. The test kit with the name Mylab PathoDetect COVID-19 Qualitative PCR kit is the first one to receive commercial approval from the Indian FDA/ Central Drugs Standard Control Organization (CDSCO). Mylab claims that one test kit can test up to 100 patients.
Mylab is manufacturing RTPCR kits from years and also a range of kits at the Indian FDA/CDSCO approved facility. Complying with MDR 2017 regulations, Mylab is manufacturing class C and D medical devices, ID-NAT screening kits for blood banks, quantitative HIV, HBV and HCV kits. Currently, to manufacture the COVID-19 Qualitative kit in the same facility, Mylab has received the clearance from Drugs Controller General of India (DCGI) and became the only Indian company to achieve 100% sensitivity and specificity in the ICMR evaluation.
Let us have a look at what Mylab Discovery Solutions Pvt Ltd has to say about the achievement:
Hasmukh Rawal, Managing Director, Mylab Discovery Solutions says: 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. 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.
Shailendra Kawade, Executive Director at Mylab says: 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.
Hitherto, the test kits were sourcing from Germany to facilitate testing to diagnose Corona virus patients throughout the country but because of the grounded airlines the supply is getting blocked and therefore the dependency is hard on foreign kits. The approval for made in India kits can change this.
Mylab is determined to manufacture about one lakh test kits in a week and that can be further increased if required. Mylab PathoDetect COVID-19 Qualitative PCR kit can screen and detect the infection in 2.5 hours which is much less as the current protocols are taking more than 7 hours. This can scale up the number of tests at the current time frame on a machine.
This is the crucial time for the whole world and this achievement is nothing but a significant move towards the fight against corona virus.

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