REG - Genedrive PLC - Clinical Trial Agreement

GenedriveAnnouncement

24/04/2024 15:45

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RNS Number : 9106L  Genedrive PLC  24 April 2024

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
prematurely(1). 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 case(2), 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:

 

 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
(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
(https://www.cdc.gov/nchs/data/vsrr/vsrr020.pdf)

 

2
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/0194599814536850
(https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/0194599814536850)

 

 

 

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