Updated: January 24, 2022 10:51:43 pm
The GenePath Dx CoviDelta RT-PCR test, developed by GenePath Diagnostics, Pune, and Ann Arbor, a Michigan-based company, is concordant with whole genome sequencing in identifying Covid-19 positive samples as belonging to the Delta-lineage or Omicron-lineage, according to an ongoing study, the makers of the test said on Monday. The test has already been approved by the Indian Council of Medical Research (ICMR) for SARS-CoV-2 detection and by the CDSCO (Central Drugs Standard Control Organisation) 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 with high sensitivity, the makers said.
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 makers added.
Dr Nikhil Phadke, Founder and Chief Scientific Officer, GenePath Diagnostics, who designed the test, in a statement issued on Monday said that the study that involves hundreds of samples is part of a long-standing private-public partnership (PPP) 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).
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PKC coordinates many projects dealing with Covid-19 across Pune city through leading Pune-based institutional partners such as the National Chemical Laboratory (NCL), the Indian Institute of Science Education and Research (IISER), and BJ Government Medical College (BJMC), where the genome sequencing takes place. It is, in fact, as a result of this partnership that the first Omicron case in Pune was identified in record time.
While congratulating GenePath Diagnostics, Professor L S 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 our armour to deal with the current pandemic effectively”.
Dr Nickhil Jakatdar, chief executive officer, GenePath Diagnostics, said, “This evaluation by PKC demonstrates the ability of the GenePath test kit to accurately differentiate between samples with the Delta VoC (variant of concern) and the Omicron VoC, leading to a lower burden on the very accurate but expensive and slower Next Generation Sequencing (NGS) machines.”
Dr Phadke further said that many doctors are now using strain information to assist in their decision-making process with regard to the treatment. “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,” Dr Phadke added.
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