“Feluda”- CRISPR based high accuracy, low cost Covid-19 test gets DCGI approval for commercial use
CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) test - FELUDA, received regulatory approvals on 19 September 2020 from the Drug Controller General of India (DCGI) for commercial launch, as per ICMR guidelines, meeting high-quality benchmarks with 96% sensitivity and 98% specificity for detecting the novel coronavirus.
Two senior scientists Dr Debojyoti Chakraborty and Dr Souvik Maiti from the Council of Scientific and Industrial Research- Institute of Genomics and Integrative Biology (CSIR-IGIB) have developed a quick paper strip Covid-19 testing kit - “Feluda.”
Using the CRISPR gene-editing technology, Feluda identifies and targets the genetic material of Sars-CoV2, the causative virus of Covid-19. This is the only Covid-19 testing kit that has been developed using CRISPR-based technology in India.
The name “Feluda” coined for the testing kit is based on a fictional detective character Feluda (alias Prodosh C Mitter) created by the legendary moviemaker late Satyajit Ray, who wrote 35 Feluda stories and made two films. But here, Feluda stands for "FnCas9 Editor Linked Uniform Detection Assay".
This test uses an indigenously developed, cutting-edge CRISPR technology for detection of the genomic sequence of SARS-CoV-2 virus. CRISPR is a genome-editing technology to diagnosing diseases. Moreover, CRISPR is a futuristic technology that can also be configured for detection of multiple other pathogens in the future.
Feluda detects active Covid-19 infection by using a CRISPR CAS 9 based readout on a paper strip - world's first kit to do so for SARS-CoV-2. 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 effort is the result of a fruitful collaboration between the scientific community and 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. The first-of-its-kind test kit that costs less than Rs 1000 can give results in one hour.
Feluda doesn’t require real-time PCR machine. It can be performed at the point of care settings where a simple PCR machine is present. The Tata CRISPR test achieves accuracy levels of traditional RT-PCR tests, with quicker turnaround time, less expensive equipment, and better ease of use.