Genedrive’s CYP2C19 ID Kit Secures CE Certification, Boosting European Market Access

PUBLISHED: 30 May 2025 @ 18:22 | Comments (0) | More info about Fiona Craig

Genedrive plc (LSE:GDR) has achieved CE certification for its Genedrive® CYP2C19 ID Kit under the European In Vitro Diagnostic Regulation, paving the way for its commercial launch across Europe and easing regulatory approvals in other international markets. The diagnostic kit swiftly identifies patients unlikely to respond to the antiplatelet drug Clopidogrel, a critical capability in urgent medical scenarios.

This certification is anticipated to strengthen Genedrive’s competitive position, potentially reducing recurrent stroke hospitalizations and delivering substantial cost savings and efficiency gains to healthcare providers, including the UK’s National Health Service (NHS).

While Genedrive demonstrates robust revenue growth and maintains a solid financial foundation, the company continues to face profitability challenges and negative cash flow. Market indicators currently point to bearish momentum, yet recent positive developments—such as fresh capital injections and strategic collaborations—highlight promising future potential.

About Genedrive

Headquartered in the UK, Genedrive plc specializes in pharmacogenetic testing, offering rapid, cost-effective point-of-care platforms that help healthcare professionals tailor medication decisions based on genetic profiles. The company leads innovation in this field with its two flagship products—the Genedrive® MT-RNR1 ID Kit and the Genedrive® CYP2C19 ID Kit—both endorsed by the National Institute for Health and Care Excellence (NICE) for use within the NHS.

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