Mylab gets DCGI commercial approval for COVID-19 test kit
New Delhi: Pune-based molecular diagnostics company Mylab Discovery Solutions on Monday said it has received commercial approval from the Central Drugs Standard Control Organisation (CDSCO) for its COVID-19 test kit. The test kit by the company is the first 'Made in India' kit to receive commercial approval from CDSCO, and is named as Mylab PathoDetect COVID-19 Qualitative PCR kit, the company said in a statement.
"With an emphasis on 'Make in India' and support from local and central government, the COVID- 19 kits have been made as per WHO/CDC guidelines. It was developed and evaluated in record time," Mylab Discovery Solutions MD Hasmukh Rawal said.
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's COVID-19 test kit screens and detects the infection within 2.5 hours as compared with over 7 hours taken by current protocols, it added.
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