Genedrive gets CE-mark for Covid-19 test kit

Molecular diagnostics company Genedrive announced on Friday that its ‘Genedrive 96 SARS-CoV-2 Kit’ was now CE-IVD marked, and available for commercial sale across the European Union, including the UK.

The AIM-traded firm said the move would also accelerate market access to countries that accept the CE-IVD mark.

It described the Genedrive 96 SARS-CoV-2 Kit as a novel polymerase chain reaction (PCR) assay, designed to detect active infection in Covid-19 patients.

The company’s PCR bead format reportedly eliminated the need for the “time consuming and error-prone” reagent preparation required in all other open-platform test kits.

Genedrive said the proprietary format would streamline laboratory workflow, thus allowing more tests to be performed in a day.

Patient samples were mixed with the PCR beads, and then analysed on a variety of existing third-party real-time PCR platforms.

During CE-IVD evaluations on 180 randomised specimens, the Genedrive 96 SARS-CoV-2 Kit achieved 100% sensitivity and 98.2% specificity, placing it in a “top tier” performance table for Covid-19 PCR tests.

The test was co-developed with Cytiva - formerly GE Healthcare Life Sciences.

Genedrive said the scalable manufacturing process used Cytiva's ‘Lyo-Stable’ validated manufacturing method, capable of producing 10,000 PCR beads per hour.

The Genedrive 96 SARS-CoV-2 Kit was described as being stable at ambient temperatures, eliminating the need for cold storage, making the test “very practical” for global export markets, the board said.

Following CE-IVD marking, the firm said it could now begin commercial sales in the UK and across the EU immediately.

It said it would begin distribution to potential customers for initial clinical evaluations, and aimed to record first commercial sales in June.

The company was also developing a point-of care version of the SARS-CoV-2 test for use with its Genedrive platform, which would enable decentralised testing.

“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,” said chief executive officer David Budd.

“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 US Food and Drug Administration, and emergency use assessment and listing with the 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.”

At 1314 BST, shares in Genedrive were up 4.56% at 172p.