Genedrive diagnostic test system gets UKCA registration

6th Sep 2023 13:55

(Sharecast News) - Point-of-care molecular diagnostics developer Genedrive announced on Wednesday that its Genedrive CYP2C19 System has received UKCA marking registration.

The AIM-traded firm said the registration would allow it to begin commercialising the product in the United Kingdom.

It said the new test focussed on pharmacogenomics, aiming to identify the suitability of clopidogrel treatment for individual patients following an ischaemic stroke or transient ischaemic attack (TIA).

Genedrive explained that a poor response to stroke treatments was common and affected up to 30% of the general population, with a recent report apparently suggesting that the figure could be as high as 50% among certain ethnic groups.

The National Institute for Health and Care Excellence (NICE) in the UK had recommended in its May draft guidance that patients who had an ischaemic stroke or TIA should undergo CYP2C19 genetic testing before treatment.

With more than 100,000 ischaemic strokes occurring in the UK and more than 60 million globally each year, the test could have broad implications for personalised medicine in stroke care.

The Genedrive CYP2C19 system operates using a single cheek swab sample, the firm explained, and is capable of identifying six crucial genetic variants of the CYP2C19 gene.

Those variants are critical in determining a patient's metabolism and activation of clopidogrel - a drug commonly used in treating strokes.

The test could be administered either at the bedside or in a ward, delivering clinically actionable results in approximately one hour.

Moreover, the system automatically interprets the genetic information for clinicians, which allows for immediate and tailored treatment planning.

The test has a 99% accuracy rate in detecting these genetic variants, according to company performance evaluations.

Genedrive said the UKCA marking would allow it to actively participate in the 'DEVOTE' programme, designed to gather additional performance data in an acute care environment.

The extended dataset would be essential for CE marking submission, enabling commercialisation across the European Union, which the company expected to accomplish by the first half of next year.

In the UK, the product would be sold through the company's direct sales team, and its widespread adoption was likely to be influenced by NICE's final recommendations, expected in December.

"UKCA marking of the Genedrive CYP2C19 test is a milestone for the company as we formally register our second pharmacogenomic test for use in emergency medicine," said chief executive officer David Budd.

"As we begin commercialisation and look to registration activities more globally, we will benefit from a rapidly evolving well documented clinical understanding and guidance for the use of genetic testing for stroke management."

Budd said the use of point-of-care testing allowed patients to be put on an optimised treatment plan as quickly as possible.

"The risk of recurrent stroke in the week after a TIA or minor stroke is up to 10%, so routine laboratory testing which can take many days or weeks is unlikely to be as appropriate as a point of care solution returning results in about one hour."

At 1321 BST, shares in Genedrive were up 9.96% at 12.37p.

Reporting by Josh White for Sharecast.com.