REG - GENinCode PLC - De Novo Update – FDA Supervisory Review

GenincodeAnnouncement

07/07/2025 07:00

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RNS Number : 9571P  GENinCode PLC  07 July 2025

 

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GENinCode Plc

("GENinCode" or the "Company")

 

De Novo Update - FDA Supervisory Review

 

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. In response to a request by the
Company for a Supervisory Review, the FDA recently provided a review of its
April 2025 assessment. While the number of the outstanding deficiencies has
been reduced, the review upheld the FDA's prior view that there remains
certain outstanding elements, including further information in relation to
clinical validation.

 

With the feedback from the Supervisory Review, the Board remains of the view
that there is a path forward to provide the further information to resolve
these deficiencies to obtain De Novo classification. Discussions with the FDA
have been productive with the outstanding deficiencies reducing. 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 has arranged further ongoing clarifictory discussions with the FDA
and will provide a further update if this provides additional information.

 

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: 020 7397 8900
 Giles Balleny (Corporate Finance)
 Nigel Birks (Life Sciences Specialist Sales)

 Harriet Ward (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)

              Tel: 020 7397 8900

 

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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