Genedrive PLC (LON:GDR) shares jumped higher on Friday as the firm said its 96 SARS-CoV-2 Kit for detecting coronavirus (COVID-19) infections is now CE-IVD marked and available for commercial sale across the European Union (EU).
Now that CE-IVD marking has been achieved, the company can commence commercial sales in the UK and across the EU immediately. The company said it will begin distribution to potential customers for initial clinical evaluations and aims to record first commercial sales in June.
The Genedrive 96 SARS-CoV-2 Kit is a new polymerase chain reaction (PCR) diagnostic test designed to detect active infection in coronavirus (COVID-19) patients.
Genedrive's PCR bead format eliminates the need for the time consuming and error-prone reagent preparation required in all other open-platform test kits, the company noted. The proprietary format streamlines laboratory workflow, allowing more tests to be performed in a day, it added.
“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,” David Budd, the chief executive officer of genedrive said in a statement.
“CE marking was achieved with performance studies and validations that will also support regulatory applications in other jurisdictions, such as Emergency Use Authorisation with the USA FDA [Food and Drug Administration] and Emergency Use Assessment and Listing with the WHO [World Health Organization].
"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 added.
in early trading, Genedrive shares were up 13.4% at 186.50p.