REG - Genedrive PLC - CE-certification

GenedriveAnnouncement

30/05/2025 07:00

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RNS Number : 6765K  Genedrive PLC  30 May 2025

genedrive plc

("genedrive" or the "Company")

 

Genedrive® CYP2C19 ID Kit receives CE-certification under the European In
Vitro Diagnostics Regulation

 

genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company,
announces the successful certification of its rapid CYP2C19 ID Kit genotyping
platform under the European In Vitro Diagnostic Regulation ("IVDR") 2017/746.
The IVDR replaces the In Vitro Diagnostic Directive ("IVDD") and is the
current required regulatory basis for placing on the market, making available
and putting into service any new In Vitro diagnostic medical devices within
the European Union, with CE-IVD certification recognised for facilitating
registration in several non-European countries.

 

Approximately 30% of individuals, and up to 56% in certain ethnic groups,
carry DNA variants in the CYP2C19 gene which result in sub-optimal activity of
the antiplatelet drug Clopidogrel, commonly prescribed in patients with
serious cardiovascular events such as Ischaemic Stroke ("IS"), Transient
Ischaemic Attack ("TIA") and Acute Coronary Syndrome, where patients with
these variants who are prescribed Clopidogrel typically experiencing worse
outcomes. The Genedrive® CYP2C19 ID Kit identifies five of these DNA
variants, some of which are particularly important in certain ethnicities.
  It enables rapid identification of patients who are unlikely to respond to
Clopidogrel, in time-critical emergency healthcare settings where rapid
appropriate antiplatelet prescription is crucial.

 

The Genedrive® CYP2C19 ID Kit rapid test is best in class, recommended by the
National Institute for Health and Care Excellence ("NICE") as the rapid
genotyping platform of choice for use in the NHS, with dominant health
economics, wider patient group coverage, and performance shown to be superior
to laboratory testing methods.

 

Dr Gino Miele, CEO of genedrive plc, said: "We are delighted to achieve this
certification for our best-in-class CYP2C19 rapid genotyping platform. IVDR
requirements have placed a heavy demand on Notified Bodies ("NB") 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.  Implementation of our rapid CYP2C19
platform has been estimated to potentially prevent c.3000 recurrent stroke
admissions annually, whilst 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."

 

 

For further details please contact:

 

 genedrive plc                                     +44 (0)161 989 0245
 Gino Miele: CEO / Russ Shaw: CFO

 Peel Hunt LLP (Nominated Adviser and Broker)      +44 (0)20 7418 8900
 James Steel

 Walbrook PR Ltd (Media & Investor Relations)      +44 (0)20 7933 8780 or genedrive@walbrookpr.com
                                                   (mailto:genedrive@walbrookpr.com)
 Anna Dunphy                                       +44 (0)7876 741 001

 

 

About genedrive plc (http://www.genedriveplc.com)

genedrive plc is a pharmacogenetic testing company developing and
commercialising a low cost, rapid, versatile and simple to use point of need
pharmacogenetic platform for the diagnosis of genetic variants. This helps
clinicians to quickly access key genetic information that will aid them make
the right choices over the right medicine or dosage to use for an effective
treatment, particularly important in time-critical emergency care healthcare
paradigms. Based in the UK, the Company is at the forefront of Point of Care
pharmacogenetic testing in emergency healthcare. Pharmacogenetics informs on
how your individual genetics impact a medicines ability to work for you.
Therefore, by using pharmacogenetics, medicine choices can be personalised,
made safer and more effective. The Company has launched its two flagship
products, the Genedrive® MT-RNR1 ID Kit and the Genedrive® CYP2C19 ID Kit,
both developed and validated in collaboration with NHS partners and deployed
on its point of care thermocycler platform. Both tests are single-use
disposable cartridges which are ambient temperature stable, circumventing the
requirement for cold chain logistics. The Directors believe the Genedrive®
MT-RNR1 ID Kit is a worlds-first and allows clinicians to make a decision on
antibiotic use in neonatal intensive care units within 26 minutes, ensuring
vital care is delivered, avoiding adverse effects potentially otherwise
encountered and with no negative impact on the patient care pathway. Its
CYP2C19 ID Kit which has no comparably positioned competitor currently allows
clinicians to make a decision on the use of Clopidogrel in stroke patients in
70 minutes, ensuring that patients who are unlikely to benefit from or suffer
adverse effects from Clopidogrel receive an alternative antiplatelet
therapeutic in a timely manner, ultimately improving outcomes. Both tests have
undergone review by the National Institute for Health and Care Clinical
Excellence ("NICE") and have been recommended for use in the UK NHS. The
Company has a clear commercial strategy focused on accelerating growth through
maximising in-market sales, geographic and portfolio expansion and strategic
M&A, and operates out of its facilities in Manchester.

 

 

 

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