Genedrive’s (LON: GDR) SARS-CoV-2 Kit has been formally approved by the Indian Council of Medical Research (ICMR), the company said on Friday, resulting in a jump in its share price.
Genedrive’s share price has risen 23.45% to 89.5p at the time of writing. For the year to date, it has gained 86.62% and just under 24% in the last month.
The Genedrive 96 SARS-CoV-2 Kit is a novel PCR assay designed to detect active SARS-CoV-2 infection in COVID-19 patients. With Covid-19 infections in India rising rapidly, the country this week began to allow the import of certain COVID test kits with foreign registrations, including CE-Marking, without the need for ICMR approval.
The AIM-listed company said the Genedrive 96 SARS-CoV-2 Kit achieved 100% sensitivity and 100% specificity in the performance evaluation conducted by the ICMR.
The company said it will now commence commercial activities in India through its existing distributor Divoc Health and seek additional routes to the market.
“We are very happy to achieve formal registration of our COVID PCR tests in India. 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,” said David Budd, Genedrive’s CEO.
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