The Tata Group has announced that the Tata CRISPR test, developed by CSIR-IGIB ‘Feluda’ (Council of Scientific and Industrial Research-Institute of Genomics and Integrative Biology) had received regulatory approvals on Saturday from the Drug Controller General of India (DCGI) for commercial roll-out in accordance with the Indian Council of Medical Research (ICMR) guidelines.
The test has met high benchmarks, with 96% sensitivity and 98% specificity for detecting the novel coronavirus. It uses indigenously developed CRISPR technology for the detection of the genomic sequence of the SARS-CoV-2 virus.
“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,” Tata Group said in a statement.
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The Tata CRISPR test achieves the accuracy levels of the traditional RT-PCR (real-time polymerase chain reaction) tests, with quicker turnaround time, less expensive equipment, and better ease of use, it said.
The effort is the result of collaboration between the scientific community and industry. The Tata Group worked closely with CSIR-IGIB and ICMR to create a high-quality test that will help India ramp up COVID-19 testing quickly and economically, with a ‘Made in India’ product that is safe, reliable, affordable, and accessible, it said.
Girish Krishnamurthy, CEO, Tata Medical and Diagnostics Limited, 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.”
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“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.
Dr. Shekhar C. Mande, Director General, CSIR, complimented the CSIR-IGIB team of scientists and students, Tata Sons and the DCGI for the work and collaboration carried out by them.
Dr. Anurag Agrawal, Director, CSIR-IGIB, said 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 a new diagnostic test for SARS-CoV-2.
The research team was led by Dr. Debojyoti Chakraborty and Dr. Souvik Maiti.