DCGI approves CRISPR-based COVID-19 testing in India

September 21, 2020 0 By FM

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.