Developed by scientists from IGIB (Institute for Genomics and Integrative Biology) of the Council for Scientific and Industrial Research in Delhi, together with the Tata Group, the test, called Feluda, will diagnose the virus in two hours.
“The Tata CRISPR test is the world’s first diagnostic test to implement a specially adapted Cas9 protein to successfully detect the virus that causes Covid-19,” a government statement said.
When the pandemic began, the IGIB team of Debojyoti Chakraborty and Souvik Maiti was working on the development of a genome-based diagnostic tool for sickle cell anemia. It took less than 100 days to “leverage” their work to develop Feluda, said IGIB director Dr. Anurag Agrawal.
A press release issued by the science and technology ministry said the test has a sensitivity of 96% and a specificity of 98% for detecting the new coronavirus. CSIR officials told TOI that it is similar to a pregnancy test, containing a strip of paper that changes color when it detects the virus in the sample.
“This marks a significant achievement for the Indian scientific community, moving from R&D to highly accurate, scalable and reliable testing in less than 100 days,” the statement said. The test, which meets the guidelines set by the Indian Council for Medical Research, can be reconfigured at a later date to detect other pathogens as well.
Official sources told TOI: “The test is a great innovation, as the results would take a while, and it has been approved after extensive validation and testing.” It has a faster response time and uses less expensive equipment, so it should be cheaper than existing tests. Accuracy is better than antigen-based kits, but must be checked in a clinical setting.
The cost of the test once marketed is estimated to be less than Rs 600, the sources said, but this could not be verified. Globally, the US drug regulator had in May granted emergency use approval for a new Coronavirus test to take advantage of CRISPR gene editing technology.
Dr. Ajay Phadke, Director of SRL Dr. Avinash Phadke Labs, said: “CRISPR-based diagnostic kits can combine the sensitivity and specificity of PCR along with the ease-of-use of test systems. lateral flow similar to card tests (antibody tests). This works very well under laboratory conditions and must be validated in a clinical setting. If successful, this enables faster, cheaper, and highly accurate infectious disease diagnosis for a wide range of diseases, including Covid-19. ”
The ministry 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 of Tata Medical and Diagnostics Ltd, said: “The approval of the Tata CRISPR test for COVID-19 will give a boost to the country’s efforts to combat the global pandemic. The commercialization of the Tata CRISPR test reflects the tremendous R&D talent in the country, which can collaborate to transform India’s contributions to the world of scientific research and global health. ”
Dr. Shekhar C Mande, DG-CSIR, also congratulated the team of scientists and students from CSIR-IGIB, Tata Group and DCGI for their work and collaboration.
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