Pune-based firm’s kit that can detect all current variants of Covid-19 gets ICMR nod

Dr Nickhil Jakatdar, Chief Executive Officer (CEO), GenePath Diagnostics, said, “This development is a step further in our mission to improve human life by building and deploying high-quality, accessible and affordable screening and diagnostic solutions for infectious diseases, cancers and genetic disorders.”

He added: “This kit is capable of detecting all important Covid-19 variants described across the world to date, including the currently dominant Delta and Omicron variants. This made-in-India kit is fast and cost-effective. It has been approved by ICMR (Indian Council of Medical Research) with 100% sensitivity and specificity.”

Dr Nikhil Phadke, Founder and Chief Science Officer at GenePath Diagnostics, said: “Using this kit, we were able to flag the presence of the first Omicron case in Pune city that was subsequently confirmed by the Government of India’s INSACOG consortium, which comprises Pune-based CSIR-NCL, IISER, BJMC and PKC among other organisations across the country. Several government and private organisations in India and internationally are now evaluating the use of this kit as part of their diagnostic and surveillance efforts.”

According to Dr Phadke, a key feature of the test kit is its ability to reliably differentiate all current Delta and Omicron lineages, including BA.1, BA.2 (also known as Omicron-like and stealth variant) and recently proposed BA.3 lineage.

All Omicron lineages share a number of common defining mutations. The BA.2 sub-lineage, however, does not carry the Spike gene del 69-70 mutation and hence, cannot be detected by the so-called S-gene target failure (SGTF) approach deployed by other commercial kits currently being used for the purpose.

A large percentage (as high as 70%) of recently sequenced cases, primarily from South Africa, Australia and Canada, reportedly belong to the BA.2 sub-lineage, and could not be flagged by the SGTF approach. GenePath’s CoviDelta kit, however, targets the downstream Spike L452R mutation, which is present in the Delta lineage, but absent in all the Omicron sub-lineages. Furthermore, the kit contains additional multiple independent Covid-19 targets providing resilience to current and emerging mutations.

GenePath’s kit will continue to detect all variants of Covid-19 with high sensitivity and specificity and reliably differentiate between all current Delta and Omicron lineages, officials said.