Genedrive secures CE certification for CYP2C19 ID Kit
Genedrive announced on Friday that it has secured CE certification for its CYP2C19 ID Kit under the European In Vitro Diagnostic Regulation (IVDR), allowing the pharmacogenetic test to be marketed and used across the EU and in certain non-European countries that recognise CE-IVD marking.
The AIM-traded firm said the IVDR replaced the earlier In Vitro Diagnostic Directive, and was now the required regulatory framework for new diagnostic medical devices.
It said its CYP2C19 ID Kit was designed to rapidly identify five DNA variants in the CYP2C19 gene that affects patient response to Clopidogrel, a widely prescribed antiplatelet drug used in the treatment of conditions such as ischaemic stroke, TIA and acute coronary syndrome.
Up to 56% of individuals in some ethnic groups carry variants linked to reduced drug efficacy, leading to poorer clinical outcomes if Clopidogrel is used.
Genedrive said the test delivers rapid results suitable for use in emergency care settings where timely prescription decisions are critical.
It was already recommended by NICE as the preferred rapid genotyping platform for NHS use, supported by superior performance, broader patient applicability, and favourable health economic analysis compared to traditional lab-based testing.
“We are delighted to achieve this certification for our best-in-class CYP2C19 rapid genotyping platform,” said chief executive officer Dr Gino Miele.
“IVDR requirements have placed a heavy demand on Notified Bodies responsible for ensuring compliance, and whilst certification of our quality management system and CYP2C19 ID kit under IVDR encountered a minor delay, it is noteworthy that this has still been achieved approximately six months earlier due to mitigation plans we put in place in August last year with respect to our NB.
“Whilst UKCA certification enabled a focus on national commercialisation routes, including implementation into routine clinical use in NHS England's largest Hyper Acute Stroke Centre, and Middle East regions, we have also focussed efforts on defining market access routes in specific European countries which CE-certification now permits, and in non-European countries in which it facilitates registrations.”
Dr Miele said implementation of the rapid CYP2C19 platform had been estimated to potentially prevent around 3,000 recurrent stroke admissions annually, while offering £160m of value, releasing 62,000 hospital beds and 230,000 healthcare professional hours in NHS England alone.
“These patient outcomes, financial and productivity gains are substantial and I am excited about the future impact of our solution to patients and healthcare systems both in the UK and internationally.”
At 1124 BST, shares in Genedrive were up 2.26% at 1.36p.
Reporting by Josh White for Sharecast.com.