RE: In bed with the Gov, newsflow rich. Target: 10 to 30p.14 Apr 2025 06:38
I believe the company can get there with its products, accreditaitons and gradual intergration into the NHS and global health systems.
Genedrive® CYP2C19
· First UK commercial sales of the Genedrive® CYP2C19-ID Kit to England's largest Hyperacute Stroke Centre
· North West Anglia Foundation NHS Trusts' Peterborough City Hospital implements the Genedrive® CYP2C19-ID Kit for routine clinical use
· Growing base of initial installations for site verifications expected to lead to subsequent routine clinical use
· Positive value assessment by the Scottish Health Technologies Group (SHTG) following referral by the Accelerated National Adoption (ANIA) pathway group in Scotland, leading to the Scottish Government announcement of investment to support national pharmacogenetic testing of CYP2C19 in Stroke patients, including genedrive's CYP2C19-ID test for rapid genetic testing in Transient Ischaemic Attack (TIA) patients
· NICE recommendation of the Genedrive® CYP2C19-ID Kit as the rapid genetic testing platform of choice for CYP2C19 genotyping strategies for clopidogrel administration in ischaemic stroke (IS) and TIA, with Genedrive's CYP2C19 ID Kit being dominant in cost effectiveness models
· Genedrive® CYP2C19-ID Kit clinical performance published in Journal of Molecular Diagnostics (December 2024), outlining superior performance to laboratory test and alternative available point of care (PoC) platforms with respect to target coverage, speed, accuracy and test fails
· Inclusion in study aimed at understanding how best to deliver CYP2C19 based genotyping at scale throughout the NHS, and accepted on NHS Dynamic Procurement System (DPS), permitting direct procurement by regional NHS trusts
· Market access routes and reimbursement strategies defined in key initial international target countries, including the Middle East region, with well-positioned and aligned in-country distributors, with required regulatory certification (CE-IVD under IVDR) on track for April 2025
· 510(k) route identified for regulatory submission for US market entry, with initial pre-submission engagement with Food and Drug Administration (FDA) held and feedback positive and with regulatory approach confirmed as appropriate
Genedrive® MT-RNR1
· Scottish Government announcement of £800k investment to support national phased implementation program of pharmacogenetic testing of MT-RNR1 in newborn babies in NHS Scotland using Genedrive's MT-RNR1 ID Kit
· NIHR and OLS Funding Package of c.£500k to address NICE Real World Evidence Generation Requirements for the Genedrive® MT-RNR1 ID Kit across 14 hospitals across the UK (PALOH-UK). Progressing as planned, with nine Group 1 sites live, with a further five Group 2 sites phased to go-live from May 2025
· 11 babies identified as positive for the MT-RNR1 DNA variant since introduction of the test into Neonatal Intensive Care Units (NICU) in the UK and avoiding lifelong hearing loss