First 'Made-in-India' COVID-19 test kit by Mylab gets commercial approval - (The Statesman via NewsPoints Desk)

  • Mylab Discovery Solutions has developed the first "Made in India" test kit for COVID-19, The Statesman reported on Tuesday.

  • The company said it has received commercial approval from the Central Drugs Standard Control Organisation (CDSCO) for the test kit, which is called Mylab PathoDetect COVID-19 qualitative PCR kit.

  • Local sourcing of test kits will be a major breakthrough for India as Mylab's test kit will cost nearly one-fourth of the current procurement cost, the company said, adding that the test screens and detects the infection within 2.5 hours as compared with over seven hours taken by current protocols.

  • ICMR director general Balram Bhargava noted that a "fast track mechanism has been set up" for COVID-19 tests, adding that "it is not mandatory that they be approved by FDA, a validation from ICMR-NIV is adequate to give them a go-ahead."

  • Roche Diagnostics India was the first private company to get COVID-19 test approval.

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