A diagnostic test that uses an indigenously developed CRISPR technology to detect the genomic sequence of the SARS-CoV-2 virus is set to hit the domestic market.
The Tata CRISPR test, powered by CSIR-IGIB FELUDA, received the Drug Controller General of India’s approval for commercial launch, as per the Indian Council of Medical Research guidelines, a note from the Tata Group said, adding that the test met the quality benchmarks with 96 percent sensitivity and 98 percent specificity for detecting the novel coronavirus.
CRISPR is a genome editing technology to diagnose diseases. But the Tata CRISPR test is touted to be the world’s first diagnostic test to deploy a specially adapted Cas9 protein to successfully detect the virus causing Covid-19, the company said. And it had accuracy levels of the traditional RT-PCR (Real Time- Polymerase Chain Reaction) tests, with quicker turnaround time, less expensive equipment, and greater ease of use, it added.
Simple to use
The test involves a coded paper-based test strip with two bars that would indicate whether the patient is positive.
Anurag Agrawal, Director CSIR-IGIB (Institute of Genomics and Integrative Biology) told BusinessLine that “it had the potential to be a gamechanger and that required further innovation in how it was deployed”, including the manner in which samples are collected and so on. The test was “comparable”, he said, to the RT-PCR test (the industry gold standard). It can be used in small labs, locations that do not have an RT-PCR, he explained, as it needed just a basic PCR machine. The entire procedure from “RNA to readout” can be completed in an hour, said one of the scientists associated with the test.
Agrawal was confident that the test would be priced balancing “sustainability and social responsibility.”
He pointed out that 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.
The development by a team led by Debojyoti Chakraborty and Souvik Maiti marked a significant achievement for the Indian scientific community, the Tata Group note said, “moving from R&D (research and development) to a high-accuracy, scalable and reliable test in less than 100 days.” According to Girish Krishnamurthy, CEO, TATA Medical and Diagnostics Ltd, the commercialisation of the Tata CRISPR test reflected the tremendous R&D talent in the country. – The Hindu BusinessLine