REG - GENinCode PLC - De Novo Submission Update

GenincodeAnnouncement

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RNS Number : 7250G  GENinCode PLC  30 April 2025

 

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF THE MARKET
ABUSE REGULATION (EU) 596 / 2014 WHICH FORMS PART OF UK LAW BY VIRTUE OF THE
EUROPEAN UNION (WITHDRAWAL) ACT 2018 .

 

 

GENinCode Plc

("GENinCode" or the "Company")

 

De Novo update

 

Oxford, UK. GENinCode Plc (AIM: GENI), the genetics company focused on the
prevention of cardiovascular disease, announces an update on its Food and Drug
Administration (FDA) De Novo submission. The FDA has provided full feedback on
the application and determined that there remains certain outstanding
elements, including deficiencies in relation to clinical validation, that need
to be addressed.

 

The Company has initiated a Supervisory Review with the FDA to address these
elements and is holding ongoing discussions and in-person meetings with the
FDA to resolve these deficiencies. The Board does not believe that there are
any elements that it cannot address, however there can be no certainty that
the information provided will be sufficient. The Company will provide a
further update at the Preliminary Results at the end of May 2025.

 

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)

 

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 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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