DCGI approves CRISPR-based COVID-19 testing in India

DCGI approves CRISPR-based COVID-19 testing in India

The Drug Controller General of India (DCGI) has recently approved India’s first Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) coronavirus test known as ‘Feluda’, announced the Tata Sons.

Feluda — an acronym for FNCAS9 Editor-Limited Uniform Detection Assay — is an indigenous COVID-19 testing mechanism that was created at the Institute of Genomics and Integrative Biology (CSIR-IGIB), a constituent lab of the Council of Scientific and Industrial Research, New Delhi.

“This test uses an indigenously developed, cutting-edge CRISPR technology for detection of the genomic sequence of 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,” said the company in the release. A combination of the CRISPR biology and paper-strip chemistry leads to a visible signal readout on a paper strip that can be rapidly assessed for establishing the presence of the viral infection in a sample.

The new test is expected to address the urgent need for accurate mass testing because of its affordability, relative ease of use and non-dependency on expensive qPCR (quantitative polymerase chain reaction) machines.

According to an official release issued by tthe Ministry of Science and Technology, The Tata CRISPR test, powered by CSIR-IGIB, received regulatory approvals from DCGI for commercial launch, as per ICMR guidelines, meeting quality benchmarks with 96% sensitivity and 98% specificity for detecting the novel coronavirus.

“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,’ it said.