genedrive
plc
("genedrive" or the
"Company")
Genedrive enters into a
Clinical Trial Agreement with a leading multi-state
physician organisation for clinical research studies of the
Genedrive® MT-RNR1 Product Range in the
USA
genedrive plc (AIM: GDR), the point
of care pharmacogenetic testing company, announces that it has
entered into a Clinical Trial Agreement with a leading multi-state
physician organisation ("Research Partner") in the USA to support
clinical studies required for engagement with the U.S. Food and
Drug Administration ("FDA") to progress the regulatory approval of
the Genedrive® MT-RNR1 ID Kit into the USA via the FDA De novo submission process.
In 2021, 3.7 million babies were
born in the United States, with 10.5% born
prematurely1. It has been
estimated that malpractice litigation settlements in cases related
to deafness caused by the use of aminoglycosides average over
US$1.1 million per case2, further adding to the positive
health economic case of providing accurate and timely testing to
reduce unwanted side effects of gentamicin usage.
The Genedrive® MT-RNR1 ID Kit is the
world's first point-of-care genetic test to reduce the risk of
antibiotic induced hearing loss (AIHL). Following detection of the MT-RNR1 variant an
alternative antibiotic treatment can be prescribed. 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 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 predicate device already cleared by the
FDA. Our partnership enables affordable access for clinical
studies in NICU sites in the United States as required for the
FDA de
novo submission process, with a
leading multi-state physician organisation with expertise and
coverage of US neonatal services.
James Cheek, CEO of genedrive plc, said:
"I am delighted
with this agreement to progress our aim of introduction of our
MT-RNR1 point of care pharmacogenetic test to the U.S. The
U.S. is a particularly 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.
Additionally, the U.S. Market is potentially the most attractive
market given its size, birth rates, use of diagnostic testing and
reimbursement structure. As already announced genedrive will
be seeking funding to progress the required clinical
studies."
For further details please
contact:
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genedrive plc
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+44 (0)161
989 0245
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James Cheek: CEO / Russ Shaw:
CFO
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Peel
Hunt LLP (Nominated Adviser and Broker)
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+44 (0)20
7418 8900
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James Steel / Patrick
Birkholm
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Walbrook PR Ltd (Media & Investor
Relations)
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+44 (0)20
7933 8780 or genedrive@walbrookpr.com
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Anna Dunphy
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+44
(0)7876 741 001
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About genedrive plc (http://www.genedriveplc.com).
genedrive plc is a pharmacogenetic testing company developing and
commercialising a low cost, rapid, versatile, simple to use and
robust point of need pharmacogenetic platform for the diagnosis of
genetic variations. This helps clinicians to quickly access key
genetic information that will help them make the right choices over
the right medicine or dosage to use for an effective treatment.
Based in the UK, the Company is at the forefront of work on Point
of Care pharmacogenetics. Pharmacogenetics looks at how your
genetics impacts a medicines ability to work for you. Therefore, by
using pharmacogenetics, medicines can be made safer and more
effective. The Company has launched its flagship product, the
Genedrive® MT-RNR1 ID Kit, which is a single-use disposable
cartridge that circumvents the requirement for cold chain logistics
by providing temperature stable reagent test kits for use on their
proprietary test platform. This test allows clinicians to make a
decision on antibiotic use within 26 minutes; ensuring vital care
is delivered with no negative impact on the patient
pathway.
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.
1 https://www.cdc.gov/nchs/data/vsrr/vsrr020.pdf
2
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/0194599814536850