REG - Genedrive PLC - First UK commercial sales of the CYP2C19-ID Kit

GenedriveAnnouncement

12/08/2024 07:00

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RNS Number : 9783Z  Genedrive PLC  12 August 2024

genedrive plc

("genedrive" or the "Company")

 

First UK commercial sales of the Genedrive® CYP2C19-ID Kit

 

genedrive plc (AIM: GDR), the point of care pharmacogenetic testing company,
is pleased to announce that following the UK's National Institute for Health
and Care Excellence ("NICE") final published guidance that CYP2C19 genotyping
should be used to guide clopidogrel use after Ischaemic Stroke ("IS") or
Transient Ischaemic Attack ("TIA"), and that the Genedrive® CYP2C19-ID test
should be used as the test of choice for point of care strategies(1), an
initial order for the CYP2C19-ID Kit and instruments has been received
(c.£0.1M) to support an implementation assessment at Greater Manchester's
Comprehensive Stroke Centre ("CSC").

 

Hyperacute Stroke units ("HASU") are part of the UK's Integrated Stroke
Delivery Network, where care typically covers the first 72 hours after
admission, with the aim that every patient with acute stroke should gain rapid
access to a stroke unit in under four hours and receive an early
multidisciplinary assessment(2).  Greater Manchester CSC is the largest and
busiest HASU in England with more than 2,000 stroke patient admissions per
annum and is situated within the Manchester Centre for Clinical Neurosciences
("MCCN") at Salford Royal Hospital, part of Northern Care Alliance NHS
Foundation Trust. The implementation assessment's aim is to establish the
benefit for patients across Greater Manchester.

 

UK NICE guidance recommends laboratory CYP2C19 genotyping, and where not
available or possible to implement point of care strategies, using the
Genedrive® CYP2C19-ID test as the platform of choice.  Whilst positioned
primarily for enabling near-patient point of care testing, the Genedrive®
System is also suitable for traditional laboratory testing paradigms as a more
affordable alternative to more expensive laboratory platforms where sample
throughput requirements do not necessitate high-scale batch processing.

 

Factoring in potential improvements in patient outcomes in addition to direct
healthcare financial savings, implementation of CYP2C19 genotyping in IS/TIA
has potential value to the NHS of approximately £91M and £454M over one and
five years respectively(1).

 

Dr Gino Miele, CEO of genedrive plc, said: "With recent NICE guidance
recommending CYP2C19 genotyping strategies in the UK NHS for IS and TIA
patients in the NHS who are eligible for receiving the antiplatelet
Clopidogrel, and recommending our test as the point-of-care platform of
choice, these initial first-sales of our CYP2C19 ID-kit in the UK to one of
the largest stroke centres nationally is a key initial milestone in our
CYP2C19  commercialisation strategy, and further strengthens our
pharmacogenetic positioning strategy in emergency care more broadly.  We look
forward to increasing implementation of our CYP2C19 test in the UK NHS and
internationally to the benefit of both healthcare systems financially and
improvement of patient outcomes."

 

Professor Bill Newman, Professor of Translational Genomic Medicine at the
University of Manchester and Lead of the NHSE Network of Excellence in
Pharmacogenetics and Medicines Optimisation at Manchester University NHS
Foundation Trust, said: "We are delighted to work with genedrive to implement
this new clinical test to ensure that patients following a stroke or a
mini-stroke get onto the best treatment as soon as possible to prevent a
further stroke."

 

Dr. Natasha James and Dr. Kirsty Ward, Clinical leads for the Greater
Manchester CSC, said: "We are delighted to work with colleagues at Manchester
Centre for Genomic Medicine and genedrive to bring the benefit of this novel
technology to Stroke patients in Greater Manchester. The technology will help
us to formulate a personalised optimal treatment plan for Stroke patients,
that we hope will prevent future strokes and save lives."

 

1.    https://www.nice.org.uk/consultations/2556/1/recommendations
(https://www.nice.org.uk/consultations/2556/1/recommendations)

2.
https://www.england.nhs.uk/wp-content/uploads/2021/05/stroke-service-model-may-2021.pdf
(https://www.england.nhs.uk/wp-content/uploads/2021/05/stroke-service-model-may-2021.pdf)

 

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 / Patrick Birkholm

 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.

 

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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