REG - Genedrive PLC - Breakthrough Device Designation from the U.S. FDA

GenedriveAnnouncement

15/07/2024 07:00

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RNS Number : 3158W  Genedrive PLC  15 July 2024

genedrive plc

("genedrive" or the "Company")

 

Breakthrough Device Designation received from the U.S. FDA

 

genedrive plc (AIM: GDR), the point-of-care pharmacogenetic testing company,
is pleased to announce that it has received Breakthrough Device Designation
from the U.S. Food and Drug Administration ("FDA") for the Genedrive® MT-RNR1
ID Kit.

The Genedrive® MT-RNR1 kit ("MT-RNR1 ID kit") is the world's first rapid
point-of-care test to screen infants in an urgent care setting for a genetic
variant that can cause life-long hearing loss when carriers of the variant are
given certain antibiotics. Those infants identified by the Genedrive® MT-RNR1
ID kit as carrying the variant can then be given alternative antibiotics.  It
has the potential to save thousands of children from lifelong hearing loss,
whilst providing a net positive financial outcome case to healthcare systems.

The Breakthrough Devices Program(1) is intended to provide patients and health
care providers with timely access to medical devices by speeding up
development, assessment, and review for premarket approval, 510(k) clearance,
and De Novo marketing authorisation. Breakthrough Devices must meet the FDA's
standards for device safety and effectiveness in order to be authorised for
marketing.

Devices subject to premarket approval applications ("PMA"), premarket
notification 510(k), or requests for De Novo classification request are
eligible for Breakthrough Device Designation if the device meets FDA criteria
that it "provides for more effective treatment or diagnosis of
life-threatening or irreversibly debilitating human disease or conditions", in
addition to "there being No Approved or Cleared Alternatives" and "Device
Availability being in the Best Interest of Patients".

The Breakthrough Devices Program offers manufacturers an opportunity to
interact with FDA experts through several different programme options to
efficiently address topics as they arise during the premarket review phase.
This interaction can help manufacturers receive feedback from the FDA and
identify areas of agreement in a timely way. Manufacturers can also expect
prioritised review of their submission

In 2021, 3.7 million babies were born in the USA, with 10.5% born prematurely.
It was estimated that malpractice litigation settlements in cases related to
deafness caused by the use of aminoglycosides average over US$1.1 million per
case, further adding to the positive health economic case of providing
accurate and timely testing to reduce unwanted side effects of gentamicin
usage.  Extrapolating from UK figures, the Company estimates that
approximately 1,000 babies per annum in U.S. Neonatal Intensive Care Units
("NICU") are at risk of aminoglycoside induced hearing loss.

genedrive intends to pursue the FDA De Novo regulatory pathway for entry into
the U.S. market.  The FDA De Novo pathway provides a vehicle for establishing
new predicate devices that can reflect modern standards for performance and
safety and can serve as a basis for future clearances.  De Novo
classification is a risk-based classification process used when there is a
lack of a predicate device already cleared by the FDA.

 

James Cheek, CEO of genedrive plc, said: "We are delighted to receive FDA
designation of our MT-RNR1 point of care pharmacogenetic test and
corresponding recognition of the potential benefits to U.S. patients.  The
U.S. is an attractive market for this unique test given the potential to save
hundreds of individuals from life-long deafness and reduce litigation costs
relating to the unwanted side effects from antibiotic use on those carrying
the gene variant, and given its size, birth rates, use of diagnostic testing
and reimbursement structure.  The FDA Breakthrough Device Designation process
will be invaluable in mitigating study design risks associated with bringing a
novel test such as this to the U.S. market where no predicate device exists
with which to align study designs to.  Together with our in-place partnership
with a multi-state physician led clinical partner with neonatal services
expertise covering the majority of U.S. states we look forward to affordable,
collaborative and timely progress through the FDA De novo process".

(1)
https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
(https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program)

 

For further details please contact:

 

 genedrive plc                                     +44 (0)161 989 0245
 James Cheek: 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.

 

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