REG - Genedrive PLC - NIHR and OLS Funding Package

GenedriveAnnouncement

21/11/2024 11:15

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RNS Number : 1836N  Genedrive PLC  21 November 2024

genedrive plc

("genedrive" or the "Company")

 

 NIHR and OLS Funding Package to address NICE Real World Evidence Generation
Requirements for the Genedrive® MT-RNR1 ID Kit

Revenue of £500k over the life of the award

 

genedrive plc (AIM: GDR), the point of care Pharmacogenetic testing company,
announces a successful funding award to its clinical partners from the
National Institute for Health and Care Research ("NIHR") in collaboration with
the UK Government Office for Life Sciences ("OLS") to address evidence
generation requirements of the National Institute for Health and Care
Excellence ("NICE") Early Value Assessment ("EVA") for the Genedrive® MT-RNR1
ID kit.

 

The NIHR/OLS Real World Evidence Programme is aimed specifically at
technologies like the Genedrive® MT-RNR1 ID kit which have been recommended
for use in the NHS via the NICE EVA, to enable the addressing of real-world
evidence gaps and the potential subsequent provision of a full
(non-conditional) recommendation by NICE to accelerate the widespread adoption
and implementation into the NHS.

 

The programme is clinician consortia-based and will be led by principal
investigators Professor Bill Newman and Dr. John McDermott (University of
Manchester / Manchester University NHS Foundation Trust), with 14 separate
hospital Neonatal Intensive Care Units across England (inclusive of some sites
which have already implemented the Genedrive® MT-RNR1 ID test as part of
routine clinical use), Scotland, Wales and Northern Ireland (inclusive of nine
sites already utilising the Genedrive® MT-RNR1 ID test in routine clinical
practice). The start date was 1 November 2024 with a maximum duration of 18
months, with sites phased into group 1 (sites already currently using the
test) and group 2 (remaining sites). Group 1 site testing is funded under the
programme for six months from project initiation, following which funding for
continuity of routine clinical practice will be required to be sought from
alternative sources by those sites.

 

Revenue to Genedrive for the MT-RNR1 ID kit under the programme is expected to
be approximately £500,000.

 

Whilst scheduled for a maximum of 18 months, performance data can be submitted
to the NICE EVA Evidence Generation team at an earlier point if the team
believes the evidence generation requirements have been successfully
fulfilled. Performance data generated during the programme is also expected to
contribute towards clinical performance data requirements for FDA as part of
planned De novo submission process required for commercial entry into the U.S.

 

Gino Miele, Chief Executive Officer of genedrive plc, said: "We are delighted
with this funding package award to our clinical collaborators, representing a
key step in enabling generation of real world evidence data requirements of
NICE to transition from conditional to full recommendation. The programme will
run in parallel with, and be complementary to, our continued sales expansion,
nationally and internationally. The goal of NIHR and the Government's Office
for Life Sciences via this programme is to drive adoption and implementation
of innovative technologies such as ours into the UK's NHS, to drive improved
patient outcomes and economic benefits."

 

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 (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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