Pune: GenePath Diagnostics develops first approved Indian kit to differentiate between Delta and Omicron Covid-19 variants in a single test
Pune, 17th December 2021: The CoviDelta kit indigenously developed by Pune-based GenePath Diagnostics has become the first ICMR approved test kit that detects all current variants of COVID-19 and flags for presumptive Delta and Omicron variants in a single test.
Dr. Nickhil Jakatdar, 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.”
Speaking about the new kit, 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 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 which was subsequently confirmed by the Government of India INSACOG consortium which comprises of Pune-based CSIR-NCL, IISER, BJMC and PKC among other organizations across the country. Several government and private organizations in India and internationally are now evaluating the use of this kit as part of their diagnostic and surveillance efforts”
According to Dr. Phadke one of the most important highlights of this test kit is its ability to reliably differentiate all current Delta lineages and all Omicron lineages including BA.1, BA.2 (also known as Omicron-like and stealth variant) and the very recently proposed BA.3 lineage. All the Omicron lineages share a number of common defining mutations. The BA.2 sub-lineage, however, does not carry the Spike gene del69-70 mutation, and hence will not be detected by the so called ‘S-gene target failure’ (SGTF) approach using other commercial kits that are currently being used for that purpose.
In fact, 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 have failed being flagged by the aforementioned SGTF approach. GenePath’s ICMR approved 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. Therefore 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.
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