DCGI nod to commercial launch of India's first low-cost COVID-19 test 'FELUDA'

The Drugs Controller General of India (DCGI) has approved the commercial launch of India's first low-cost test 'FELUDA' for commercial use. The Tata CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) and the Council of Scientific and Industrial Research (CSIR)- Institute of Genomics and Integrative Biology (IGIB) have jointly developed the COVID-19 test.

The Tata CRISPR test meets high-quality benchmarks with 96 per cent sensitivity and 98 per cent specificity for detecting the novel coronavirus. "This test uses an indigenously developed, cutting-edge CRISPR technology for detection of the genomic sequence of SARS-CoV-2 virus," a government statement said.

Notably, the Tata CRISPR test is the world's first diagnostic test to deploy a specially-adapted Cas9 protein to successfully detect the virus that causes COVID-19. "This marks a significant achievement for the Indian scientific community, moving from R&D to a high-accuracy, scalable and reliable test in less than 100 days," the statement added.

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The Tata CRISPR test achieves accuracy levels of traditional RT-PCR tests, with quicker turnaround time, less expensive equipment, and better ease of use.

CRISPR is a genome-editing technology to diagnosing diseases. It can also be configured for detection of multiple other pathogens in the future.

"The effort is the result of a fruitful collaboration between the scientific community and industry. The Tata Group has worked closely with CSIR-IGIB and ICMR to create a high-quality test that will help the nation ramp up COVID-19 testing quickly and economically, with a 'Made in India' product that is safe, reliable, affordable, and accessible," the statement added.

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Girish Krishnamurthy, CEO, TATA Medical and Diagnostics Ltd, said the approval for the Tata CRISPR test for COVID-19 will give a boost to the country's efforts in fighting the global pandemic. "The commercialisation of the Tata CRISPR test reflects the tremendous R&D talent in the country, which can collaborate to transform India's contributions to the global healthcare and scientific research world," he said.

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Dr Shekhar C Mande, DG-CSIR, complimented the CSIR-IGIB team of scientists and students, TATA Sons and DCGI for the exemplary work and collaboration carried out amid the pandemic.

Anurag Agrawal, director, CSIR-IGIB, said the work started by CSIR under the sickle cell mission for genome diagnostics and therapeutics led to new knowledge that could be harnessed to quickly develop a new diagnostic test for SARS-CoV-2.

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