Genedrive PLC (LON:GDR) shares jumped higher on Wednesday as it told investors that the US Food & Drug Administration (FDA) that it intends to import and distribute its 96 SARS-CoV-2 kit in the US prior to emergency use authorisation (EUA).
The company said it had taken the decision in order to support its collaboration agreement with Beckman Coulter that will see the pair bring to the market a fully automated coronavirus (COVID-19) testing solution. It also wants to “exploit commercial opportunities”.
Genedrive pointed out the FDA does not object to the distribution of SARS-CoV-2 test kits without emergency use sign-off under certain defined conditions as coronavirus cases in the US continue to soar.
It notified the regulator of its plans on November 25 and received an acknowledgement on December 15.
The current claims of the product cover high throughput testing on a variety of platforms for upper respiratory tract specimens.
The product will be labelled thus: 'Validation of this test has not been reviewed by FDA. Review under the EUA programme is pending'.
Confident in performance claims
In a statement, genedrive 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 morning trading, genedrive shares were 20% higher at 51.50p.
In a note to clients, analysts at City broker Peel Hunt repeated a 'buy' rating on the stock and said: "We continue to think that genedrive’s freeze-dried bead chemistry is ideally suited for use on high-throughput robotic platforms (its remains stable for hours after unsealing and does not require the fluid dispensing steps seen in other automated assays) giving it a crucial differentiator.
"This FDA notification will support the transition of genedrive’s 96 SARS-CoV-2 Kit to clinical use in the US, alongside Beckman’s Biomek system, allowing it to exploit commercial opportunities."
-- Adds share price, broker comment --