Shares for the Manchester-based company were boosted 13.4 percent to 186.50p, it was reported in early trading. Sales of the new testing devices are expected to begin in June, according to the firm.

Molecular diagnostics firm Genedrive PLC saw shares skyrocket on Friday after the company announced its 96 SARS-CoV-2 testing kits were certified for commercial sale in the European Union.

Earning certification in line with the EU directive on in-vitro diagnostic medical devices (CE-IVD) allows Genedrive to begin  sales in the UK and EU, with the company stating it will send kits to potential customers for initial clinical evaluation.

The kits can detect active COVID-19 infections in patients using a polymerase chain reaction (PCR), significantly reducing testing time and streamlining workflows in laboratories to boost daily testing quotas, a company statement read in late May.

“The development teams at Genedrive and at Cytiva have worked tirelessly over the past two months to develop our unique product that has the potential to streamline lab testing, improve quality, and ultimately allow more people to be tested,” chief executive David Budd said in a statement.

Achieving CE markings will also help back regulatory bodies in other countries such as the Food and Drug Administration in the United States as well as Emergency Assessment and Listing with the World Health Organisation, he added.

“The temperature stable nature of the Genedrive 96 SARS-CoV-2 kit means we have the potential to easily access these global markets, which are in urgent need of testing efficiency and volume,” he concluded.

The news comes after Genedrive announced in April a deal with therapeutics manufacturer Cytiva to develop testing kits in five weeks amid concerns the UK government was failing to meet testing quotas across the UK.

Criticisms were launched against Health Secretary Matt Hancock in April after he was unable to verify whether the government could meet its 100,000 test a day quota.

Nearly 89,800 tests were administered on 18 May, with 2.8m tests in total. Despite testing efforts, over 35,000 people have died to date, the UK Department of Health and Social Care tweeted this week.

NHS X, the UK’s digital innovation wing for the National Health Services, launched trials of its contact tracing app on the Isle of Wight in early May. The app, which monitors COVID-19 cases across the country, is expected to be launched in late May.


Genedrive Stocks Soar as COVID-19 Rapid Test Kits Granted UK, EU Sales, WHO Early Assessment Listing

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