Genedrive shares jump on NICE test recommendation

Genedrive shares were surging on Wednesday, after it received a significant endorsement from the UK's National Institute for Health and Care Excellence (NICE) regarding its ‘CYP2C19-ID’ test.

The AIM-traded firm said that in draft guidance, NICE recommended the point-of-care (POC) genetic test before administering clopidogrel in the management of ischemic stroke (IS) and transient ischaemic attack (TIA) patients.

Clopidogrel, an antiplatelet drug crucial in reducing the risk of blood clots following IS or TIA, relies on metabolism by an enzyme encoded by the CYP2C19 gene.

However, variations in that gene could hinder the enzyme's function, leading to suboptimal response to clopidogrel in certain individuals.

The company described the Genedrive CYP2C19-ID test as a swift and non-invasive solution, using a single cheek swab sample to identify six key genetic variants of the CYP2C19 gene.

It said the Genedrive System then promptly interpreted that information for clinicians, enabling tailored treatment plans.

With more than 77 million global cases of ischaemic stroke reported by the World Stroke Organization, and around 100,000 strokes occurring annually in the UK according to the Stroke Association, there was a strong need for effective antiplatelet treatment.

Suboptimal response affected 20% to 30% of the general UK stroke population, rising to 50% to 60% in specific ethnic groups.

NICE's draft guidance, issued in May last year, emphasised the importance of CYP2C19 genetic testing before antiplatelet treatment for IS or TIA.

A public consultation on the draft guidance was ongoing until 26 April, with final recommendations anticipated on 10 July.

Highlighting the superiority of the Genedrive platform, the company said NICE recommended it as the preferred POC system for CYP2C19 genotyping in the NHS.

That decision was reportedly based on various distinguishing features, including broader coverage of genetic variants, eliminating the need for cold-chain storage logistics, and seamless integration with patient electronic healthcare systems.

“We are delighted to receive this recommendation from NICE for our CYP2C19 point of care pharmacogenetic test,” said chief executive officer James Cheek.

“The NHS has done significant work on both strokes and mini strokes, with campaigns for FAST - face, arms, speech, time - and promoting changing lifestyles to prevent a stroke.

“This guidance is just the next step in stroke management, ensuring that if you have a stroke, specifically related to a disruption of the blood flow, that the medicine given has a positive effect.”

Cheek said clopidogrel was the NICE recommended front-line treatment for those types of strokes.

“However, if you are one of the estimated 20% to 30% who are unable to metabolise Clopidogrel effectively you have the opportunity to be identified quickly and given an alternative medication.

“We are delighted to be part of this change which is in line with our strategy to deliver point-of-care pharmacogenetic testing to positively impact patient outcomes.

“With MT-RNR1 getting a NICE EVA conditional recommendation last year, further funding applied for to achieve a full recommendation this year, a strategy in place to achieve FDA approval and sales being realised from new customers in 2024 we feel there is growing momentum within the group's POC pharmacogenetic testing strategy.”

At 1335 BST, shares in Genedrive were up 42.13% at 5.33p.

Reporting by Josh White for Sharecast.com.