By Josh White
Date: Friday 16 Jun 2023
LONDON (ShareCast) - (Sharecast News) - Molecular diagnostics specialist Genedrive announced its involvement in a multi-partner grant award called DEVOTE on Friday, supported by Innovate UK and the UK government's Innovation Accelerator programme.
The AIM-traded company said the grant aimed to provide funding for the validation and implementation of the new Genedrive CYP2C19 ID Kit pharmacogenetic test in a time-critical clinical setting.
It said that under the grant, Genedrive would have the opportunity to assess the real-world clinical performance of time-critical clinical tests in an NHS setting, with acute care patient access and necessary supporting infrastructure.
The University of Manchester (UoM) would lead the programme, building on the successful partnership between UoM and Genedrive in the past PALOH programme, which contributed to the development and evaluation of the Genedrive MT-RNR1 ID Kit, recently recommended by NICE.
It said DEVOTE would bring together various stakeholders, including health economists, clinicians, informaticians, and researchers, to rapidly evaluate new technologies and provide iterative feedback.
Genedrive said its CYP2C19 ID Kit was one of three exemplar projects selected for the programme, which was expected to receive funding from the Innovate grant, in-kind contributions, and other aligned funding.
The primary allocation of funding was expected to go directly to the UoM and its NHS partners to establish and coordinate the three projects, with the exact amount to be determined in due course.
Genedrive said the focus of DEVOTE would be on ischaemic stroke patients in acute care who were likely to be prescribed Clopidogrel as a preventive measure against further clot formation.
However, Clopidogrel's efficacy is reduced in individuals with specific genetic CYP2C19 variants that affect its metabolism.
Genedrive's CYP2C19 ID Kit was designed to provide guidance at the point of care, enabling healthcare professionals to identify patients who would respond fully to Clopidogrel.
For patients with gene variants associated with reduced or loss of function of CYP2C19, alternative treatments could then be administered.
"DEVOTE is an amazing opportunity to engage formally with a health system like the NHS to demonstrate the effectiveness of a new diagnostic approach," said chief executive officer David Budd.
"Access to the Acute Medicine Unit in real time has considerable value to Genedrive as further funding would allow us to progress ongoing product development quickly and efficiently, and would support the pathway to clinical validation of our Genedrive CYP2C19 ID Kit.
"This level of clinical input and evaluation is increasingly required by regulatory authorities prior to marketing product especially in the EU."
At 1026 BST, shares in Genedrive were up 10.14% at 19p.
Reporting by Josh White for Sharecast.com.
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