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genedrive COVID-19 PCR test approved by the Indian regulator

The plan is to begin “commercial activities” through its existing local distributor Divoc Health, the company said

Genedrive PLC -

genedrive PLC (LON:GDR) said its COVID-19 PCR test has been approved by the Indian regulator after it achieved 100% sensitivity and specificity in a performance evaluation conducted by the country’s Council of Medical Research.

The plan is to begin “commercial activities” through its existing local distributor Divoc Health, the company said, adding it will also be “seeking additional routes to the market”.

Chief executive David Budd told investors: “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."

The 96 SARS-CoV-2 test uses a "ready-to-go" solid PCR bead format that eliminates the need for reagent preparation or cold temperature storage, making it ideal for use in hotter climate countries such as India.

It also streamlines laboratory workflow, allowing a patient sample to be mixed with a single bead and then tested on third-party platforms. The test is validated for use on certain Biorad, ThermoFisher, and Roche PCR systems.

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Price: 25.25 GBX

Market Cap: £15.99 m

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