GenePath Diagnostics develops quantitative COVID-19 test kit for drug makers

Pune-based GenePath Diagnostics has developed a quantitative RT-PCR test which will enable therapeutic drug and vaccine makers to test the efficacy of their product. The test kit will help accelerate the time to market for both vaccines and therapeutic drugs for Covid-19, according to the molecular diagnostics clinical lab and kit developer.

The kit is currently being used by a couple of unidentified drug makers in India, said GenePath Diagnostics CEO Nickhil Jakatdar. He said this is the first quantitative test kit of its kind in India for Covid-19 and over time it could be used to test for other infectious diseases as well.

GenePath Diagnostics is also in talks with vaccine makers for this solution.

Most RT-PCR tests use the threshold cycle (Ct) value to provide an estimate of the viral load in the patient to determine the severity of the infection. Because of the differences in various kits, the same swab is likely to show different Ct values on different kits, making it difficult to run comparisons. The GenePath kit calibrates the Ct values across machines and kits to the patient’s viral load through its interpretation algorithm and calibration standards. This has been fine-tuned through thousands of clinical samples.

GenePath has been testing Covid samples at its labs and recently received approval from the Central Drug Standards Control Organisation (CDSCO) for its Covid-19 RT-PCR test kit. It is the first organisation in India to both run an Indian Council of Medical Research-approved Covid-19 testing lab and its own RT-PCR test kit.

“Being a clinical lab, we knew the practical considerations and constraints that had to be kept in mind while creating the test kit,” said Jakatdar.

While GenePath has tied up with another lab in the US for its Covid-19 test kit, Jakatdar said the company will focus on India at present for the quantitative test kit.