REG - GENinCode PLC - CARDIO inCode Lab Fee Update & Catalonia Launch

GenincodeAnnouncement

23/01/2025 07:00

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RNS Number : 3733U  GENinCode PLC  23 January 2025

23 January 2025

 

 

GENinCode Plc

("GENinCode" or the "Company")

 

CARDIO inCode® inclusion in the US CMS 2025 Clinical Lab Fee Schedule

and launch in the Spanish region of Catalonia

 

Oxford, UK. GENinCode Plc (AIM: GENI), the genetics company focused on the
prevention of cardiovascular disease, announces the inclusion of CARDIO inCode
(for the polygenic risk assessment of coronary heart disease) in the US 2025
Clinical Lab Fee Schedule (CLFS) to enable reimbursement from Medicare and
Medicaid across the US. The company also announces the implementation of
CARDIO inCode for the prevention of coronary heart disease (CHD) in the
Spanish region of Catalonia.

 

The CARDIO inCode-Score test is being clinically adopted across leading US
healthcare institutions and has now been included in the Centers for Medicare
and Medicaid Services (CMS) Clinical Lab Fee Schedule (CLFS) from 2025. The
CARDIO inCode test (CPT code: 0401U) price varies on a state by state basis
ranging from $450 - $570 with a median price of ~$500/test. The company is
also progressing its FDA 'de novo' submission for CARDIO inCode and expects to
provide an update on progress over the coming months.

 

Following earlier CARDIO inCode test pilots across Spain, the Catalonia
ministry of health has agreed to implement CARDIO inCode to improve the risk
assessment of cardiovascular disease in primary care through the Catalan
Health Institute - ICS ("Institut Català de la Salut"). Catalonia is one of
17 Spanish regions providing state based health services to prevent CHD. Out
of a total Spanish population of approximately 48 million, the Catalonia
region has a population of 7.7m. CARDIO inCode will be provided to patients
aged between 45 to 64 years targeting those at risk of CHD estimated at up up
to 476,000 patients in the Catalonia region. Test volumes are expected to
escalate up to approximately 1,000 patient tests through this year with
volumes expanding as increasing numbers of physicians, community practices and
regions are educated and onboarded for testing. The Company is also
progressing pilot preparations for CARDIO inCode in other Spanish regions.

 

GENinCode specialises in polygenic risk assessment for the prevention of CHD.
CHD is the most common form of heart disease and the leading cause of death
worldwide and in the United Kingdon and United States.

 

In the UK around 7.6m people live with heart and circulatory disease, which
causes 25% of all deaths annually. CHD can be reduced by identifying and
treating individuals at risk, and the NHS 10 Year Plan (2019) focused on
addressing CVD prevention.

 

Matthew Walls, CEO of GENinCode PLC said: "The start of US revenues and
inclusion in the CMS Clinical Lab Fee Schedule supports the US scale-up of
CARDIO inCode for prevention of coronary heart disease. We anticipate an
acceleration in adoption of CARDIO inCode across US states and health
institutions post FDA approval. The success of the CARDIO inCode CHD
prevention program in the Catalonia region of Spain marks a significant
milestone allowing us to cross apply this state based primary care program to
other Spanish regions."

 

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 / Dan Hodkinson (Corporate Finance)

 Nigel Birks (Life Sciences Specialist Sales)

 Ondraya Swanson (Corporate Broking)

 Dale Bellis / Michael Johnson (Sales)

 Walbrook PR Limited                                 Tel: 020 7933 8780 or
 Anna Dunphy / Louis Ashe-Jepson / Phillip Marriage  genincode@walbrookpr.com (mailto:genincode@walbrookpr.com)

 

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) 596/2014, as it forms part of domestic law by virtue of the
European Union (Withdrawal) Act 2018. The person responsible for arranging
the release of this announcement on behalf of GENinCode Plc is Matthew Walls,
Chief Executive Officer.

 

About GENinCode:

GENinCode Plc is a UK based company specialising in genetic risk assessment of
cardiovascular disease. Cardiovascular disease is the leading cause of death
and disability worldwide.

 

GENinCode operates business units in the UK, Europe through GENinCode S.L.U,
and in the United States through GENinCode U.S. Inc.

 

GENinCode predictive technology provides patients and physicians with globally
leading preventative care and treatment strategies. GENinCode CE marked
invitro-diagnostic molecular tests combine clinical algorithms and
bioinformatics to provide advanced patient risk assessment to predict
cardiovascular disease.

 

About Cardiovascular Disease (CVD):

Heart and circulatory disease known collectively as Cardiovascular disease
(CVD) are the leading cause of death globally, taking an estimated 17.9
million lives each year. CVD is a group of disorders of the heart and blood
vessels that include coronary heart disease, cerebrovascular disease,
rheumatic heart disease and other conditions. More than four out of five CVD
deaths are due to heart attacks and strokes, and one third of these deaths
occur prematurely in people under 70 years of age.

 

Coronary heart disease (CHD) is the most common type of heart disease. In 2021
in the US, coronary heart disease accounted for 375,476 deaths. About 1 in 20
adults age 20 and older have CHD (about 5%). In 2021, about 2 in 10 deaths
from CHD happened in adults less than 65 years old. Globally it is estimated
around 200 million people are living with coronary heart disease. Around 110
million men and 80 million women have coronary heart disease. Coronary heart
disease kills an estimated nine million people each year - in 2019 it was the
world's single biggest killer.

 

In the UK, cardiovascular disease causes a quarter of all deaths and is the
largest cause of premature mortality in deprived areas and the single biggest
area where the NHS can save lives over the next 10 years. CVD is largely
preventable, through lifestyle changes and a combination of public health and
NHS action on smoking and tobacco addiction, obesity, tackling alcohol misuse
and food reformulation.

 

Aside from the genetic risk of cardiovascular disease, the most important
behavioural risk factors of heart disease and stroke are unhealthy diet,
physical inactivity, tobacco use and harmful use of alcohol. The effects of
behavioural risk factors may show up in individuals as raised blood pressure,
raised blood glucose, raised blood lipids,  excess weight and obesity. These
"clinical risks factors" can be measured in primary care facilities and
indicate an increased risk of heart attack, stroke, heart failure and other
complications.

 

Identifying those at highest risk of coronary heart disease and ensuring they
receive appropriate treatment can prevent premature deaths. Access to
medicines and basic health technology in all primary health care facilities is
essential to ensure that those in need receive treatment and counselling.

 

Early detection and treatment of CVD can help patients live longer, healthier
lives is set out in the NHS 10 Year Plan. Too many people are still living
with undetected, high-risk conditions such as raised cholesterol, high blood
pressure and atrial fibrillation (AF). Globally, healthcare systems are making
progress on identification and diagnosis of high genetic risk individuals and
working towards people routinely knowing and understanding their 'ABC' (AF,
Blood pressure and Cholesterol risk). Replicating this approach is now
increasingly possible with advanced molecular testing and digital technology.

 

 

 

 

 

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