The kit has also received formal approval from the Indian Council of Medical Research (ICMR)
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 (CDSCO) for Genedrive 96 SARS-CoV-2 testing kits in India, the startup said in a statement.
It also said that the Genedrive 96 SARS-CoV-2 Kit has been designed by molecular diagnostics Genedrive located in the United Kingdom, and has also received formal approval from the Indian Council of Medical Research (ICMR).
On receiving the approval, Dr Kanav Kahol, founder and CEO, DIVOC Health, said, “We thank the diagnostic division of the 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.”
The kit 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, added the statement.