India's First 'Tata CRISPR' Covid-19 Test Gets Approval by DCGI for Commercial Launch

The Tata CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) test, powered by CSIR-IGIB (Institute of Genomics and Integrative Biology), received regulatory approval on Saturday from the Drug Controller General of India for its commercial launch, meeting high-quality benchmark with 96 per cent sensitivity and 98 per cent specificity for detecting novel coronavirus.

The test uses an indigenously developed, cutting-edge CRISPR technology for detection of the genomic sequence of the SARS-CoV-2 virus. CRISPR is a genome editing technology for diagnosing diseases.

The Tata CRISPR test is the world’s first diagnostic test to deploy a specially adapted Cas9 protein to successfully detect the virus causing 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 Tata CRISPR test achieves accuracy levels of traditional RT-PCR tests, with quicker turnaround time, less expensive equipment, and better ease of use. Moreover, CRISPR is a futuristic technology that can also be configured for the detection of multiple other pathogens in the future.

The effort is the result of a fruitful collaboration between the scientific community and the 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.

Commenting on the development, 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 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.”

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 during the current pandemic, leading to the approval of the novel diagnostic kit and paving the path for further innovations towards making India self-reliant.

Anurag Agrawal, Director, CSIR-IGIB, expressed delight that 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 new diagnostic test for SARS-CoV-2.

He emphasised that this shows the interconnectedness of scientific knowledge and technology and the innovation of the young research team led by Debojyoti Chakraborty and Souvik Maiti.