NEW YORK – Genedrive, the University of Manchester (UoM), Health Innovation Manchester, and Manchester University NHS Foundation Trust (MFT) are participating in a program to assess the real-world performance of Genedrive’s CYP2C19 ID Kit, the company said on Friday.
Manchester, UK-based Genedrive received a Development and Validation of Technology for Time Critical Genomic Testing (DEVOTE) grant from the UK government to validate its kit with a focus on ischaemic stroke patients in acute care who are to receive clopidogrel to prevent further clot formation.
The CYP2C19 ID Kit genotypes these patients to estimate how well they might respond to clopidogrel.
UoM will lead the DEVOTE program, building on an earlier partnership with Genedrive in the Pharmacogenetics to Avoid Loss of Hearing (PALOH) program, which contributed to the development and evaluation of the Genedrive MT-RNR1 ID Kit, which recently received a recommendation from the UK National Institute for Health and Care Excellence (NICE).
Other participants will include health economists, clinicians, informaticians, and researchers, tasked with rapidly evaluating new technologies and providing iterative feedback.
Under the grant, Genedrive and collaborators will be able to conduct their assessments with acute care patient access and necessary supporting infrastructure.
Program funding comes from Innovate UK and the UK government Innovation Accelerator program, as well as from in-kind contributions and aligned funding. The amount of funding was not disclosed.
Funding will go directly to UoM and its NHS partners, to establish and coordinate three pharmacogenetic projects, including Genedrive's, with the total amount of funding to be determined over time.
"We look forward to working with Genedrive and our other DEVOTE programme colleagues in Manchester to develop a framework for time-critical pharmacogenetics, and to provide the framework for assessment of implementation of the Genedrive CYP2C19 ID Kit in emergency care," William Newman, professor of translational genomic medicine at the University of Manchester and the program leader, said in a statement.
Genedrive obtained CE-IVD marking for its MT-RNR1 ID Kit in 2019. The test was the focus of a study published last year. Last year, NICE mentioned the test in a Medtech Innovation Briefing, and later initiated a DAP of Genedrive's test, guidance for which is expected by September of this year.