Genedrive receives approval for COVID-19 PCR test in India
(GDR ) announced that it has received formal registration by the Indian Council of Medical Research ("ICMR") for its Genedrive® 96 SARS-CoV-2 Kit in the Indian market.
Following the approval, Genedrive will commence commercial activities in India through its existing distributor Divoc Health and will also be seeking additional routes to the market.
Given the escalating infection rate in the country, earlier this week India began to allow the import of certain COVID test kits with foreign registrations, including CE-Marking, without the need for ICMR approval this week. According to Johns Hopkins University data, India is the second worst-hit country in the world in terms of the total COVID-19. reported cases.
Today, Health ministry data showed there were 386,452 cases over a 24-hour period — the highest daily increase globally, with at least 3,498 people having died in that time.
In April, India reported more than 6.6m cases with the total number of cases at 18.76m.
India has also introduced pricing controls into the public market, setting a dynamic that does favour the provision of "basic" tests. However, Genedrive said it believes that formal performance evaluation data and ICMR approval ‘will contribute positively to commercial efforts and premium products such as its own can play a part in the need for testing.
The Group’s Genedrive® 96 SARS-CoV-2 Kit is a novel Polymerase Chain Reaction ("PCR") assay designed to detect active SARS-CoV-2 infection in COVID-19 patients. The "ready-to-go" solid PCR bead format eliminates the need for reagent preparation or cold temperature storage, making it a preferable solution for high temperature countries such as India.
The PCR bead format streamlines lab workflow, which allows a patient sample to be mixed with a single bead and then tested on a variety of third-party RT-PCR platforms. Genedrive’s test is validated for use on certain Biorad, ThermoFisher, and Roche PCR platforms.
The near patient molecular diagnostics company’s Genedrive® 96 SARS-CoV-2 Kit achieved 100% sensitivity and 100% specificity in the performance evaluation conducted by the ICMR.
David Budd, CEO of Genedrive, said: "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."
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