Genedrive Covid-19 test formally approved in India

Molecular diagnostics company Genedrive announced on Friday that the ‘Genedrive 96’ SARS-CoV-2 kit had been formally approved by the Indian Council of Medical Research (ICMR).

The AIM-traded firm said the kit achieved 100% sensitivity and 100% specificity in the performance evaluation conducted by the ICMR.

It would now begin commercial activities in India through its existing distributor Divoc Health, and would also seek additional routes to the market.

The company described the Genedrive 96 SARS-CoV-2 Kit as a novel polymerase chain reaction (PCR) assay, designed to detect active SARS-CoV-2 infection in Covid-19 patients.

Its proprietary ‘ready-to-go’ solid PCR bead format eliminated the need for reagent preparation or cold temperature storage, making it a solution for high temperature countries such as India.

The format streamlined 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.

Genedrive said the test was validated for use on certain Biorad, ThermoFisher, and Roche PCR platforms.

Given the escalating infection rate in the country, India has started to allow the import of certain Covid-19 test kits with foreign registrations, including CE-marking, without the need for ICMR approval.

The country had also introduced pricing controls into the public market, setting a dynamic that favoured the provision of ‘basic’ tests.

Genedrive said it believed that formal performance evaluation data and ICMR approval would contribute positively to commercial efforts, however, with “premium products” such as its own still playing a part in the need for coronavirus testing.

“We are very happy to achieve formal registration of our Covid-19 PCR tests in India,” said chief executive officer David Budd.

“Although the process took longer than anticipated, the performance data is excellent and will support the commercial process and customer engagement.

“Formal product approval is an excellent testament to our technology.”

At 1259 BST, shares in Genedrive were up 24.36% at 90.16p.