Genedrive upbeat on publication of clinical performance data

The AIM-traded firm said the study highlighted the test’s advantages over laboratory platforms and other point-of-care alternatives in identifying genetic variants critical for guiding the use of clopidogrel in patients with ischemic stroke (IS) and transient ischemic attack (TIA).

It said the Genedrive CYP2C19-ID Kit, UKCA certified and recommended by NICE for NHS use, employs a simple cheek swab to detect loss-of-function variants in the CYP2C19 gene.

Those genetic variants can reduce the effectiveness of clopidogrel in approximately 30% of individuals, with some variants being more prevalent in specific ethnic groups.

Unlike other point-of-care platforms, the Genedrive test detects five loss-of-function variants, providing broader genetic coverage and improving patient outcomes.

The company said the study, conducted on a cohort of 202 patients in acute emergency care, demonstrated that the Genedrive test delivered superior accuracy, speed, and reliability compared to traditional laboratory methods.

It achieved 100% sensitivity and specificity, outperforming laboratory platforms that produced incorrect results in 4% of samples.

The Genedrive test also reduced the time to results, a critical factor in emergency settings, and exhibited a failure rate of just 0.98% - three times lower than that of laboratory platforms.

Furthermore, it identified genetic variants in seven patients that would have been missed by both laboratory genotyping methods and competing point-of-care platforms, which target fewer genetic variants.

The system also overcomes logistical challenges, such as the requirement for freezer storage of reagents, making it more practical for use in clinical environments.

Genedrive said the study concluded that the CYP2C19-ID Kit provided an accurate, rapid, and cost-effective alternative to laboratory testing, establishing it as a vital tool for personalised medicine in acute care settings and reinforcing its position as the test of choice for CYP2C19 genotype-guided prescribing in the NHS.

“We are delighted with the clinical performance of our CYP2C19 ID Kit reported in this publication,” said chief executive officer Gino Miele.

“With recommendation by NICE as the PoC test of choice for CYP2C19 genotyping in IS/TIA in NHS England, dominant health economic modelling by NICE, positive value assessment by the Scottish Health Technology Group, together with this study evidencing superior performance compared to laboratory testing and by extrapolation our nearest competitor product, we are well positioned to capitalise on the emerging clinical pharmacogenetics area of point of care CYP2C19 genotype-guided clopidogrel treatment both domestically and internationally, ultimately enabling better patient outcomes, improving equitable access to healthcare and positively impacting healthcare financial burdens.”

At 1139 GMT, shares in Genedrive were up 4.48% at 2.38p.

Reporting by Josh White for Sharecast.com.