REG - GENinCode PLC - Presentation at European Society of Cardiology

GenincodeAnnouncement

30/08/2023 07:00

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RNS Number : 7147K  GENinCode PLC  30 August 2023

GENinCode Plc

("GENinCode" or the "Company")

 

CARDIO inCode® study on risk of incident Coronary Heart Disease

presented at European Society of Cardiology Annual Meeting in Amsterdam

 

Oxford, UK. GENinCode Plc (AIM: GENI), the polygenics company focused on the
prevention of cardiovascular disease, announces the presentation by Kaiser
Permanente, US on the 'Utility of the CARDIO inCode-Score® CHD polygenic risk
score for incident coronary heart disease interplay with lifestyle in a
multi-ethnic cohort of more than 60,000 individuals'. The presentation was
made at the Annual Meeting of the European Society of Cardiologists Congress
over 25-28 August 2023 in Amsterdam.

 

The study investigated over 60,000 adult individuals with no history of
Coronary Heart Disease (CHD) from the Genetic Epidemiology Resource in Adult
Health and Aging (GERA) multi-ethnic cohort of the Kaiser Permanente Medical
Care plan of Northern California, USA. The GERA cohort followed the membership
over an average of 14 years, using CARDIO inCode-Score® to assess the
polygenic risk of CHD, interplay with lifestyle and the incidence of CHD.

 

The study found that genetic and lifestyle factors are independently
associated with the incidence of CHD and for individuals with a high polygenic
risk measured by CARDIO inCode-Score®, a favourable lifestyle was associated
with a 52% lower rate of CHD compared with an unfavourable lifestyle. The
study also found that CARDIO inCode-Score® can identify individuals at the
highest risk of CHD. These individuals should then be prioritized for
lifestyle advice and where appropriate therapeutic intervention as they will
benefit the most. By stratifying patients based on their polygenic risk score
and targeting treatment to those with the highest risk score, the number of
patients  needing to be treated to prevent a CHD event were almost halved.
CHD 'event' includes: non-fatal AMI, angina and coronary revascularization
procedures (coronary by-pass or percutaneous intervention or CHD death. The
study confirmed the earlier in life preventative measures can be put in place
the lower the future risk underlining the need for 'polygenic risk score'
lifetime risk assessment to be used in conjunction with traditional clinical
risk assessment.

 

Other recently announced news

As previously announced, GENinCode is commencing Early Access Programs for
CIC-SCORE (or CARDIO inCode-Score®) with leading healthcare institutions in
the United States to provide an improved estimation of an individual's risk of
heart attack over their lifetime. CIC-Score is now being commercially
delivered from the GENinCode CLIA and CAP approved laboratory in Irvine,
California.

 

As also announced, the Company has recently filed its CIC-Score pre-market
notifification (510k) medical device filing with the FDA. The Company expects
to receive FDA approval for the CIC-SCORE medical device over the next 6
months enabling scale up and processing by CLIA labs across the United States.

 

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

 

Matthew Walls, CEO of GENinCode PLC said: "We are delighted with the results
from this latest Kaiser Permanente milestone study. The ESC presentation
represents the first of a number of publications showing the clinical utility
of the CARDIO inCode-Score® (polygenic risk score) to identify individuals at
high genetic risk of coronary heart disease, thereby enabling targeted,
personalised treatment and a breakthrough in preventive care."

 

 

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

 Stifel Nicolaus Europe Limited (Nomad and Joint Broker)                                      Tel: +44 (0)20 7710 7600
 Alex Price / Ben Maddison / Richard Short

 Cenkos Securities Plc (Joint Broker)   Tel: +44 (0)20 7397 8900
 Giles Balleny
 Dale Bellis / Michael Johnson (Sales)

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

 Anna Dunphy / Phillip Marriage / Louis Ashe-Jepson

 

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 CARDIO inCode-Score (CIC SCORE)

CIC-SCORE is a first in class in-vitro diagnostic test used to assess an
individuals genetic risk of CHD. The test is based on published clinical
evidence amassed over 15 years which, combined with traditional clinical risk
factors, provides a comprehensive risk assessment (clinical + genetic) of CHD
for use in primary preventive care. GENinCode labs process patient DNA samples
and deliver the CARDIO inCode-Score® test results to physicians via a online
cloud based algorithmic reporting system ('SITAB').

 

CIC-SCORE also addresses the well-recognised need for improvement in the
cardiovascular disease (CVD) standard of care across ethnicities where
individuals from certain racial and ethnic groups face higher risks of CVD.
The CIC-SCORE test provides an improved estimation of an individual's risk of
heart attack over their lifetime, particularly within a 10-year period post
testing when combined with traditional clinical risk assessment. The CIC-SCORE
polygenic risk score enables a major improvement in patient CVD risk
assessment, preventive care and personalised treatment to reduce the incidence
of major adverse cardiovascular events (MACE), such as heart attack or stroke.

 

About Kaiser Permanente:

Founded in 1945, Kaiser Permanente is one of the United States largest
not-for-profit health plans, serving more than 9 million members, with
headquarters in Oakland, California.

 

It comprises: Kaiser Foundation Hospitals and their subsidiaries Kaiser
Foundation Health Plan, Inc. The Permanente Medical Groups.

 

Kaiser Permanente physicians are responsible for medical decisions. The
Permanente Medical Groups, which provide care for Kaiser Permanente members,
continuously develop and refine medical practices to help ensure that care is
delivered in the most efficient and effective manner possible.

Kaiser Permanente's creation resulted from the challenge of providing
Americans medical care during the Great Depression and World War II, when most
people could not afford to go to a doctor. Among the innovations it has
brought to U.S. health care are:

·    Prepaid health plans, which spread the cost to make it more
affordable

·    Physician group practice to maximize their abilities to care for
patients

·    A focus on preventing illness as much as on caring for the sick

·    An organized delivery system, putting as many services as possible
under one roof.

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.  It is clear that the earlier in life preventative
measures can be put in place the lower the future risk.

 

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 preventative approach to CVD.

 

 

 

 

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