In a bid to address the immediate need for “high-quality” Covid-19 tests, DIVOC Health has received an import license from the Central Drugs Standard Control Organisation (CDSC) of the Union Ministry of Health and Family Welfare, for Genedrive® 96 SARS-CoV-2 testing kits in India, the company said.
Following the approval, the diagnostic startup DIVOC health will be able to spot the active SARS-CoV-2 infection quickly and easily in Covid-19 patients with the help of the Genedrive 96 SARS-CoV-2 kit designed by molecular diagnostics Genedrive located in the United Kingdom, which has received formal approval by the Indian Council of Medical Research (ICMR), it said.
“We thank the diagnostic division of Ministry of Health for considering our proposal and allowing us to deliver quality results to the consumers. At this time when the virus is rigorously spreading in the country, we understand that the availability of accurate and high-quality tests is critical to our fight against the pandemic, and hence, we identified the GeneDrive RT PCR Covid-19 tests as well suited to the Indian market due to its comparatively reduced processing steps, thermostability, and its high-quality manufacture,” Dr Kanav Kahol, Founder and CEO, DIVOC Health said.
The kit is a novel Polymerase Chain Reaction (PCR) assay, which the company said, is designed to detect active SARS-CoV-2 infection in Covid-19 patients. It is in a ready-to-go solid PCR bead format that eliminates the need for reagent preparation or cold temperature storage, which makes it a more suitable solution for high-temperature countries such as India. The format simplifies laboratory workflow, allowing a patient sample to be mixed with a single bead and then tested on a variety of third-party RT-PCR platforms.