REG - GENinCode PLC - Approval of CARDIO inCode-score in New York state

GenincodeAnnouncement

03/12/2025 07:00

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RNS Number : 9693J  GENinCode PLC  03 December 2025

3 December 2025

GENinCode Plc

("GENinCode" or the "Company")

 

New York State clinical test approval of CARDIO inCode-score®

 

GENinCode Plc (AIM: GENI), the Oxford based predictive genetics company
focused on the prevention of coronary heart disease ("CHD" or "Heart Disease")
and risk assessment of ovarian cancer, announces today the test approval by
the New York State Department of Health, Clinical laboratory Evaluation
Program, of CARDIO inCode-Score® Polygenic Risk Score ("PRS") for the
prediction and prevention of coronary heart disease.

 

The approval of CARDIO inCode-Score® test by New York State now enables full
state coverage under US Centers for Medicare and Medicaid Services (CMS) with
the test included in the 2025 Clinical Laboratory Fee Schedule at an average
reimbursement of ~$500.00 per test.

 

New York State clinical test approval requires rigorous analytical and
clinical test validation, extensive quality documentation and the completion
of a comprehensive application and laboratory audits. Test approval of CARDIO
inCode-Score® allows GENinCode to collect patient samples from New York State
physicians, clinics, and health institutions for testing at its Irvine,
California lab facility which has also received a New York State clinical test
permit.

 

CARDIO inCode-Score® is a clinically validated, commercially available
polygenic risk score 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.

 

GENinCode continues to progress discussions with the FDA and expects to submit
additional data requested to complete its De Novo assessment in Q1. 2026.
 Approval by the FDA is required to sell the test in a medical device/kit
format that can be used across a broad range of US laboratories.

 

Matthew Walls, GENinCode Chief Executive Officer said: "Following careful
evaluation by the New York State Department of Health, we are delighted to
receive CARDIO inCode-Score® test approval to commercially promote CARDIO
inCode-Score® for genetic risk prediction of heart disease in the New York
State. The approval also provides further support for our FDA De Novo
assessment."

 

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

 

About CARDIO inCode-Score®

By integrating CARDIO inCode-Score® (PRS) 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 PRS conferring substantially
greater lifetime risk.

 

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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