REG - GENinCode PLC - Collaboration with Thermo Fisher

GenincodeAnnouncement

04/12/2025 07:00

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RNS Number : 1811K  GENinCode PLC  04 December 2025

4 December 2025

GENinCode Plc

("GENinCode" or the "Company")

 

CARDIO inCode-Score® collaboration with Thermo Fisher Scientific

Commercialisation agreement to sell, distribute and manufacture CARDIO
inCode-Score®

for the genetic risk prediction and prevention of coronary heart disease

 

GENinCode Plc (AIM: GENI), the Oxford based predictive genetics company
focused on the prevention of cardiovascular disease ("CVD") and risk
assessment of ovarian cancer, announces today a collaboration with Thermo
Fisher Scientific to sell, distribute and manufacture the CARDIO
inCode-Score® Polygenic Risk Score ("PRS") test for the prediction and
prevention of coronary heart disease ("CHD" or "heart disease").

 

Collaboration

The GENinCode and Thermo Fisher Scientific collaboration includes
manufacturing of CARDIO inCode-Score® and sale and distribution across the US
and Europe, Middle East and Africa (EMEA) regions. Prior to US FDA approval,
laboratories will be introduced to CARDIO inCode-Score® as a Lab Developed
Test (LDT) for the prevention of heart disease. Following FDA Medical Device
approval, the collaboration will extend to manufacturing and sale of the
device to laboratories and test centres across the US. A similar approach will
be adopted in the EMEA market.

 

With the US and EU cardiovascular devices market estimated at US$22.8 billion
and Euro€12.5 billion respectively, and 80% of heart disease and stroke
being preventable, the collaboration will provide the CARDIO inCode-Score®
test to assess an individual's genetic risk of heart disease. The test process
will use GENinCode's proprietary 'SITAB' system for clinical testing, AI
bioinformatics and risk reporting.

 

Thermo Fisher Scientific has been chosen as the preferred partner based on the
design and development of the CARDIO inCode-Score® test on the QuantStudio™
5 Dx Real-Time PCR System. The QuantStudio™ 5 Dx Real-Time PCR System is
globally available with significant coverage across the US and EMEA region.
Increasing demand for CARDIO inCode-Score® will be met by Thermo Fisher
Scientfic scale up of the test manufacturing.

 

The CARDIO inCode-Score® test recently received New York State licensure to
complete its US Centers for Medicare and Medicaid Services (CMS) state
coverage with the test included in the 2025 Clinical Laboratory Fee Schedule
at an average reimbursement of ~$500.00 per test.

 

GENinCode continues to progress discussions with the FDA and expects to submit
additional data requested to complete its De Novo assessment in Q1. 2026.

 

CARDIO inCode-Score® (PRS)

CARDIO inCode-Score® is a clinically validated, commercially available
polygenic risk score (PRS) based on DNA extracted from a simple saliva or
blood sample. The extracted DNA is scored to identify an individual's
inherited genetic risk of heart disease thereby enabling prevention through
lifestyle change and/or therapeutic treatment. The test has been designed and
optimized for population-based risk prediction and primary prevention of heart
disease and is being made available at affordable pricing to international
healthcare systems.

 

By integrating CARDIO inCode-Score® into existing clinical pathways,
healthcare providers can more accurately identify individuals at heightened
'lifetime risk' of heart disease and personalise treatment and prevention
strategies. This preventive approach reduces the incidence of severe
cardiovascular events, such as heart attacks and strokes, and mitigates the
economic costs associated with long-term heart disease care. It represents a
significant step to improving public health outcomes and particularly in
addressing the global burden of cardiovascular disease.

 

CARDIO inCode-Score® has amassed significant clinical evidence across
multi-ancestry populations with the tests now being clinically adopted in EU,
UK and US. Recent peer-reviewed studies using CARDIO inCode-Score® have
demonstrated genetic risk significantly influences the relationship between
LDL-cholesterol and heart disease, with the combination of elevated
LDL-cholesterol and a high CARDIO inCode-Score®  conferring substantially
greater lifetime risk.

 

Matthew Walls, GENinCode Chief Executive Officer said; "We are delighted to
announce this milestone collaboration with Thermo Fisher Scientific to scale
CARDIO inCode-Score across the US and EMEA markets. The collaboration advances
our commercial pathway and will accelerate the adoption of CARDIO inCode-Score
well beyond our current capabilities. The collaboration also underpins our
US-FDA and EU-IVDR Medical Device 2026 expansion plans."

 

For more information visit www.genincode.com (http://www.genincode.com)

 

Enquiries:

 

 GENinCode Plc                               www.genincode.com
                 (http://www.genincode.com) or via Walbrook PR
 Matthew Walls, CEO

 Cavendish Capital Markets Limited                                  Tel: +44 (0)20 7397 8900
 Giles Balleny (Corporate Finance)
 Nigel Birks (Life Sciences Specialist Sales)
 Harriet Ward (Corporate Broking)
 Dale Bellis / Michael Johnson (Sales)

 Walbrook PR Limited
 Anna Dunphy / Marcus Ulker       Tel: 020 7933 8780 or genincode@walbrookpr.com
                                  (mailto:genincode@walbrookpr.com)

 

 

Notes for editors

 

Coronary Heart Disease

Coronary Heart Disease (CHD), is the leading cause of death globally and is
responsible for approx. 9 million deaths annually and estimated to affect over
250 million people suffering with symptoms of CHD(1). In the UK, it is the
most common form of death and disability, with approximately 2.3 million
people living with the condition(2).

 

CHD occurs when the coronary arteries, which supply blood to the heart, become
narrowed by build-up of fatty materials (cholesterol and other lipids) which
give rise to what is commonly known as atherosclerosis or heart disease.
Atherosclerosis restricts blood flow to the heart causing symptoms like angina
(chest pain) with increasing atherosclerosis burden giving rise to heart
attack (or ischemic stroke) if the artery becomes completely blocked by a
blood clot.

 

(1.                   ) World Health Organisation -
www.who.int (http://www.who.int) - The leading causes of death

(2.                   ) British Heart Foundation -
www.bhf.org.uk (http://www.bhf.org.uk) - Statistics

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