NEW YORK ─ Genedrive said Friday that it has received the CE mark for its Genedrive 96 SARS-CoV-2 Kit and is making it available for sale in the European Union, including the UK, and other countries that accept the mark.
The Genedrive 96 SARS-CoV-2 Kit, a PCR assay that detects active infection, streamlines laboratory workflows, enabling more tests to be performed in a day, the firm said.
The Manchester, UK-based company said the assay's PCR bead format eliminates the need for time-consuming and error-prone reagent preparation required in other open-platform test kits. Patient samples are mixed with the PCR beads and then analyzed on a variety of third-party real-time PCR platforms.
During evaluations for CE marking of 180 randomized specimens, the Genedrive 96 SARS-CoV-2 Kit achieved 100 percent sensitivity and 98.2 percent specificity, the firm said, adding that the kit is stable at ambient temperatures which eliminates the need for cold storage.
Genedrive codeveloped the test with Marlborough, Massachusetts-based Cytiva, formerly GE Healthcare Life Sciences and now part of Danaher. The kit uses Cytiva’s Lyo-Stable scalable manufacturing method, capable of producing 10,000 PCR beads per hour.
The molecular diagnostics firm said it will begin distributing the kit to potential customers for initial clinical evaluations, and it aims to record first commercial sales in June. The firm is developing a point-of care version of the SARS-CoV-2 test for its Genedrive platform.
"CE marking was achieved with performance studies and validations that will also support regulatory applications in other jurisdictions, such as Emergency Use Authorization with the [US Food and Drug Administration] and Emergency Use Assessment and Listing" with the World Health Organization, Genedrive CEO David Budd said in a statement.
Cytiva is also collaborating with Wetherby, UK-based Avacta to develop and manufacture a point-of-care rapid test to screen large populations for SARS-CoV-2.