TIDMGENI
RNS Number : 7147K
GENinCode PLC
30 August 2023
GENinCode Plc
("GENinCode" or the "Company")
CARDIO inCode (R) 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(R) 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(R) to assess the
polygenic risk of CHD, interplay with lifestyle and the incidence
of CHD.
The study found that g enetic and lifestyle factors are
independently associated with the inciden ce of CH D and f or
individuals with a high polygenic risk measured by CARDIO
inCode-Score (R) , 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 (R) 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 . T he 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(R) ) 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(R)
(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
Enquiries:
GENinCode Plc 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(R) 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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