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NEW DELHI/MUMBAI: An indigenously developed test that uses the cutting-edge CRISPR gene-editing technology to detect the SARS-CoV-2 virus that causes the Covid-19 infection accurately, cheaply and quickly has been approved for commercial launch by the Drugs Controller General of India.

Developed by scientists from the Council of Scientific and Industrial Research’s IGIB (Institute of Genomics and Integrative Biology) in Delhi, along with the Tata Group, the test – named Feluda – will diagnose the virus in two hours.

“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 a government statement.

When the pandemic began, the IGIB team of Debojyoti Chakraborty and Souvik Maiti was working on developing a genome-based diagnostic tool for sickle cell. They took less than 100 days to “harness’’ their work to develop Feluda, said IGIB director Dr Anurag Agrawal.

A press release issued by the ministry of science and technology said the test has 96% sensitivity and 98% specificity for detecting the novel coronavirus. CSIR officials told TOI that it is similar to a pregnancy test, containing a strip of paper that changes colour on detection of the virus in the sample.

“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,’’ said the statement. The test, which meets guidelines set by the Indian Council for Medical Research, can at a later date be reconfigured to detect other pathogens as well.

Official sources told TOI, “The test is a great innovation as it would take a short while for the results, and has been approved after thorough validation and testing.” It has a quicker turnaround time and uses less expensive equipment so should be cheaper than existing tests. Accuracy is better than antigen-based kits, but has to be checked in a clinical setting.

The cost of the test once commercialised is estimated to be under Rs 600, sources said, but this could not be verified. Globally, the US drug regulator in May had granted emergency-use approval for a new Coronavirus test to take advantage of gene-editing technology CRISPR.

Dr Ajay Phadke, head at SRL Dr Avinash Phadke Labs, said, “CRISPR-based diagnostics kits can combine the sensitivity and specificity of PCR along with the ease of use of lateral flow assay systems similar to card tests (antibody tests). This works very well under lab conditions and needs to be validated in a clinical setting. If successful, this allows faster, cheaper and a very accurate infectious disease diagnosis for a wide range of diseases including Covid-19.”

The ministry’s statement said the Tata Group worked closely with CSIR-IGIB and ICMR “to develop a ‘Made in India’ product that is safe, reliable, affordable, and accessible.”

Girish Krishnamurthy, CEO, Tata Medical and Diagnostics Ltd, said, “Approval for the Tata CRISPR test for COVID-19 will give a boost to the country’s efforts in fighting the global pandemic. 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.”

Dr Shekhar C Mande, DG-CSIR, also complimented the CSIR-IGIB team of scientists and students, Tata Group and DCGI for their work and collaboration.

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