REG - GENinCode PLC - CARDIO inCode-Score 510(k) FDA submission update

GenincodeAnnouncement

29/11/2023 07:15

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RNS Number : 9694U  GENinCode PLC  29 November 2023

GENinCode Plc

("GENinCode" or the "Company")

 

GENinCode to transition CARDIO inCode-Score (CIC-SCORE) 510(k) FDA submission
to De Novo pathway

De Novo approval will enable a new regulatory class for the commercial
distribution of CARDIO inCode-Score medical device

 

Oxford, UK. GENinCode Plc (AIM: GENI), the polygenics company focused on the
prevention of cardiovascular disease ("CVD"), announces it has agreed with the
Food and Drug Administration (FDA) to create a new regulatory class for
polygenic risk scores and transition its premarket notification 510(k)
submission to a De Novo submission. The new regulatory class clearance of
CARDIO inCode will enable GENinCode to commercially advance US national
distribution of the CARDIO inCode-Score polygenic test kit (medical device)
for the risk assessment and prevention of Coronary Heart Disease ("CHD").

 

Following the CARDIO inCode-Score 510(k) medical device submission in August
2023, the FDA has reviewed the submission and recently noted CARDIO
inCode-Score's 'first in class' position and the deep clinical evidence for
polygenic risk assessment of CHD. Based on these factors and the novel
position of CARDIO inCode-Score, the FDA has requested the Company to
transition to a De Novo pathway for market approval. The crossover to a De
Novo pathway enables the Company to work with the FDA to establish a new
polygenic regulatory class for the CARDIO inCode-Score medical device based on
its favourable benefit-risk profile and associated special controls thereby
setting a new regulatory standard for future polygenic tests in this class.
Following the FDA request, the Company has now submitted its De Novo
submission for market clearance and expects a timeline to clearance broadly in
line with earlier the earlier 510(k) submission forecasts of late Q1/early Q2
2024.

 

CARDIO inCode-Score or CIC-SCORE is an in-vitro diagnostic test used to assess
an individual's polygenic risk of CHD based on DNA analysis. Published
clinical evidence amassed over the past 15 years shows that the test when
combined with traditional clinical risk assessment, provides a comprehensive
risk assessment of CHD for use in primary preventive care. GENinCode processes
and delivers the CIC-SCORE test results to physicians via its online 'SITAB'
cloud based reporting system.

 

The CIC-SCORE test addresses the well-recognised need to improve the CHD
standard of care by providing a genetic (polygenic) risk assessment for CHD,
thereby improving preventive care, patient management, and personalised
treatment.

 

GENinCode has commenced Early Access Programs for CARDIO inCode-Score with
leading institutions in the United States to provide an improved estimation of
an individual's risk of heart attack over their lifetime. The test is
currently being delivered from the GENinCode CLIA and CAP approved laboratory
in Irvine, California.

 

Matthew Walls, CEO of GENinCode PLC said: "The Board are delighted with FDA
recognition of the advanced clinical position of CARDIO inCode-Score and their
decision to create a new regulatory class for polygenic risk assessment. We
expect the De Novo pathway to provide an improved route to gaining US
regulatory approval of CARDIO inCode-Score for the polygenic risk assessment
of Coronary Heart Disease."

 

This announcement contains inside 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: +44 (0)20 7397 8900
 Giles Balleny/ Dan Hodkinson (Corporate Finance)

 Nigel Birks (ECM)

 Dale Bellis / Michael Johnson (Sales)

 Walbrook PR Limited                                                  Tel: 020 7933 8780 or genincode@walbrookpr.com

                                                                    (mailto:genincode@walbrookpr.com)
 Anna Dunphy / Louis Ashe-Jepson /

                                                                    Mob: +44 (0)7876 741 001 / +44 (0)7747 515 393
 Phillip Marriage

                                                                      +44 (0) 7867 984 082

 

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 preventive care and treatment strategies. GENinCode genetic tests
combine clinical algorithms and bioinformatics to provide advanced patient
risk assessment for coronary heart disease.

 

About Cardiovascular Disease (CVD):

Heart and circulatory disease also known as cardiovascular disease (CVD) is
the leading cause of death globally, taking an estimated 17.9 million lives
each year, with Coronary Heart Disease (CHD) representing the leading
cause of death for men, women, and people of most racial and ethnic groups
in the United States. 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. By 2030 the global cost
of CVD is set to rise from approximately US$863 billion in 2010 to US$1,044
billion and is both a major health issue and global economic burden.

 

Cardiovascular disease, causes a quarter of all deaths in the UK and is the
largest cause of premature mortality in deprived areas and is 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 action on smoking and tobacco addiction, obesity, tackling alcohol
misuse and food reformulation.

 

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, and overweight and
obesity. These "intermediate 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 CVDs and ensuring they receive
appropriate treatment can prevent premature deaths. Access to noncommunicable
disease medicines and basic health technologies in all primary health care
facilities is essential to ensure that those in need receive treatment and
counselling.

 

The current standard of care for assessing cardiovascular risk is primarily
based on traditional clinical risk factors such as age, sex, smoking, body
mass, blood pressure and cholesterol levels from which individuals are
categorised as being at low, moderate or high risk of a CVD event. This
categorisation is imperfect as CVD events frequently occur in those thought to
be at low or moderate risk. The size of the populations at low or moderate
risk are much larger than those at high or very high risk so whilst the
relative risk of a CVD event may be small, the absolute number of CVD events
in low and moderate risk populations is much greater than the number of events
in higher risk categories.

 

Clinicians have for many years recognised the importance of prior CVD events
within the families of their patients because genetic factors contribute to
the development of atherosclerosis and a patient's family history has become a
surrogate for their inherited genetic risk. In recent years, with the advances
of genomics, it has proved possible to add genetic profiling to conventional
CVD risk factors, the combination of the two (genetics and conventional
clinical risk factors) enhancing the predictive capability of patient risk
thereby resulting in a personalised and preventive approach to CVD.

 

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