Another Genedrive test to be assessed by NICE

(Sharecast News) - Near-patient molecular diagnostics company Genedrive announced on Monday that the UK's National Institute for Health and Clinical Excellence (NICE) has started an evaluation of CYP2C19 genotype testing for clopidogrel treatment, via a new NICE diagnostics assessment programme (DAP).

The AIM-traded firm said its CYP2C19 ID kit, currently in development, would be included in the assessment.

Both of its new emergency point-of-care genetic screening tests were now included in new NICE reviews, following the MT-RNR1 DAP announcement on 16 June.

Clopidogrel is a drug that is given to ischemic stroke patients to prevent further clot formation.

The CYP2C19 gene is involved in a metabolic pathway in the liver that converts clopidogrel to its active form.

Clopidogrel is less effective in individuals with certain genetic CYP2C19 variants, because they do not metabolice clopidogrel fully.

As a result, it has a reduced impact on lowering the risk of a further stroke.

Genedrive's CYP2C19 ID kit was designed to provide guidance on which patients would respond to clopidogrel, as patients with gene variants that result in reduced or loss of function of CYP2C19 could be given alternative treatments.

Genedrive described its CYP2C19 test as a simple, rapid point-of-care test, with no requirement for result interpretation, providing results in a "clinically actionable" timeframe.

The test was designed to have extended coverage across ethnic populations, which the firm said was important because the frequency of the various CYP2C19-related genetic changes differed across ethnicities.

"We are pleased to be included as a participant in this latest NICE DAP programme," said chief executive officer David Budd.

"The review is very timely for us, given the current development of our new CYP2C19 ID point-of-care test."

Budd said the clinical landscape for genotype-guided antiplatelet therapy had advanced in the last two years, with a growing number of pharmacogenetic clinical bodies recommending genotype-guided clopidogrel administration.

"These guidelines and ongoing supporting factors such as this new NICE review serve to mature the market and ultimately can create a faster rate of adoption for new products such as our new Genedrive CYP2C19 ID kit."

At 1013 BST, shares in Genedrive were down 1.44% at 17.99p.

Reporting by Josh White at Sharecast.com.