COVID-19 testing kit to be distributed across North America
Genedrive said it has notified the Food and Drug Association (FDA) of its intention to import and distribute its coronavirus testing kit, Genedrive 96 SARS-CoV-2, in the US.
The Manchester-based molecular testing business said notification was made on November 25, and acknowledged yesterday, December 15.
The current claims of the product cover high throughput testing on a variety of third-party platforms for upper respiratory track specimens.
Chief executive, David Budd, said: “Genedrive submitted its application to the FDA in May of this year but owing to the volume of applications received we are still waiting for EUA review.
“However, in order to support the Beckman Biomek system’s transition into clinical use and exploit commercial opportunities, the product needs to be commercially available in the United States to end users.
“We are confident in the performance claims of our assay and have generated independent evaluation data in the United States at non-automated sites and our automated Biomek installations which confirm our product claims.”
In light of the increasing numbers of COVID-19 cases throughout the US and the need to expand capacity for COVID-19 testing during the public health emergency, the FDA has stated that it does not object to a commercial manufacturer’s development and distribution of SARS-CoV-2 test kits for specimen testing for a reasonable period of time, where the test has been validated and while the manufacturer has made an Emergency Use Authorization request, where the manufacturer gives appropriate notification of validation to FDA, and where the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s website.
The product will bear labelling stating that “validation of this test has not been reviewed by FDA. Review under the EUA program is pending”, said the company.
In May this year Genedrive announced that its kit was available for sale across the European Union, and UK.
The Genedrive 96 SARS-CoV-2 Kit is a novel polymerase chain reaction (PCR) assay designed to detect active infection in COVID-19 patients.
Genedrive said its PCR bead format eliminates the need for the time-consuming and error-prone reagent preparation required in all other open-platform test kits.
The format streamlines laboratory workflow, allowing more tests to be performed in a day.
Patient samples are simply mixed with the PCR beads, and are 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.