Pune firm says its RT-PCR test can detect 'all current, previous' relevant strains of coronavirus

The GenePath Dx CoviDelta RT-PCR test, which was developed by GenePath Diagnostics - a Pune and USA based company, has been found to be 100 per cent concordant with whole-genome sequencing in identifying Covid-19 positive samples as belonging to the Delta-lineage or Omicron-lineage - the two most widespread lineages currently in global circulation, a release from the firm said.

The GenePath Dx CoviDelta RT-PCR test, which was developed by GenePath Diagnostics - a Pune and USA based company, has been found to be 100 per cent concordant with whole-genome sequencing in identifying Covid-19 positive samples as belonging to the Delta-lineage or Omicron-lineage - the two most widespread lineages currently in global circulation, a release from the firm said. According to the release, the test has already been approved by ICMR for SARS-CoV-2 detection and by the CDSCO (Central Drugs Standard Control Organization) for manufacturing.

The test, which uses multiple distinct markers across the SARS-CoV-2 genome to increase sensitivity and resilience to emerging mutations in the virus, is capable of detecting all current and previous clinically relevant strains of SARS-CoV-2 with high sensitivity.

''One of these markers (the Delta-Omicron on-off marker) is a unique target in the SARS-CoV-2 S-gene which enables rapid presumptive identification of Delta-lineage and Omicron-lineage samples using the WHO recommended S-gene target amplification (SGTA) and S-gene target failure (SGTF) approaches in tandem. Thus a single rapid test can be used to detect all Covid-19 variants while specifically flagging the two most dominant variants currently in circulation,'' the release state. Nikhil Phadke, Founder & Chief Scientific Officer, GenePath Diagnostics, who designed the test, revealed that this ongoing study that involves hundreds of samples is part of a long-standing and highly fruitful private-public partnership between GenePath Diagnostics and Pune Knowledge Cluster (PKC) - an apex body established by the Principal Scientific Advisor to the Government of India and administered by the Inter-University Center for Astronomy and Astrophysics (IUCAA).

''PKC coordinates many projects dealing with Covid-19 across Pune city through leading Pune-based institutional partners like the National Chemical Laboratory (NCL), the Indian Institutes of Science Education and Research (IISER) and BJ Government Medical College (BJMC), where the genome sequencing takes place. It is in fact through this very partnership, that the first Omicron case in Pune was identified in record time,'' said the release. Professor LS Shashidhara, Principal Investigator PKC, said the tests carried out at IISER Pune and CSIR-NCL suggest that GenePath Dx CoviDelta RT-PCR test is a valuable addition in their armor to deal with the current pandemic effectively.

Nickhil Jakatdar, CEO, GenePath Diagnostics added that this evaluation by PKC demonstrates the ability of the GenePath test kit to accurately differentiate between samples with the Delta VoC vs. the Omicron VoC, leading to a lower burden on the very accurate but expensive and slower Next Generation Sequencing (NGS) machines”.

Phadke further noted that many doctors are now using strain information to assist in their treatment decision-making process, and this ability to economically and rapidly type strains at the time of diagnosis allows clinicians to make decisions on patient management within clinically relevant timelines.