RNS Number : 8369X
10 January 2022
10 January 2022
("GENinCode" or the "Company")
FDA Pre-Submission filed for Cardio inCode-SCORE
Commencement of regulatory pathway for US market approval
Oxford, UK. GENinCode Plc (AIM: GENI), the predictive genetics
company focused on the prevention of cardiovascular disease,
announces the filing of its Pre-Submission for Cardio inCode-SCORE
with the Food and Drug Administration (FDA). Cardio inCode-SCORE is
an in-vitro diagnostic test which assesses an individual's combined
genetic and clinical risk to predict and prevent cardiovascular
Following extensive exchange of information and constructive
discussions with the FDA, GENinCode has been invited by the FDA to
file its Pre-Submission for Cardio inCode-SCORE. This marks the
commencement of the regulatory pathway for US market approval,
which is anticipated later this year. The FDA views Pre-Submission
as a structured process for managing and tracking interactions
between manufacturers and the FDA about the application for
approval or clearance, prior to final submission. It is an
interactive process designed to give the opportunity to obtain FDA
feedback on the application with the goal of making the end
submission process more efficient.
Matthew Walls, CEO of GENinCode Plc, said: "Despite the delays
driven by the pandemic, the filing of the Cardio inCode FDA
Pre-Submission marks the start of the US regulatory approval
pathway and ongoing preparation for the launch of Cardio
inCode-SCORE later this year. Recognition of inherited genetic
contribution to the onset of cardiovascular disease continues to
grow. We are well placed to improve the CVD standard of care by
identifying individuals at high genetic risk who can be advised on
lifestyle choices and access to personalised treatment to improve
future health outcomes."
GENinCode specialises in polygenic risk assessment of CVD, the
leading cause of death and disability worldwide. CVD is a broad
disease classification which encompasses conditions such as
coronary artery disease (causing angina, heart attack and heart
failure), cerebrovascular disease (causing stroke, and some
dementia), peripheral vascular disease (causing limb ischaemia, and
some chronic kidney disease) and venous thromboembolism. CVD
accounts for an estimated 17.9 million deaths globally each year
and accounts for 1 in every 4 deaths in the United States. 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.
The Cardio inCode-SCORE test assesses an individual's inherited
genetic (DNA) risk of cardiovascular disease together with their
clinical risk to provide a comprehensive risk assessment of CVD for
use in primary preventative care. It also addresses the
well-recognised need for improvement in CVD standard of care
practices. The test provides a greatly improved estimation of an
individual's risk of a CVD event (e.g. heart attack) particularly
within a 10-year period following the test. Cardio inCode-SCORE
provides a step change in patient risk assessment for CVD thereby
providing a major improvement in preventative care, patient
management, diagnosis, and personalised treatment.
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.
Genetic assessment will help to identify individuals in low or
moderate risk populations who are at higher risk of a CVD event
than their traditional clinical risk categorisation would suggest.
This allows earlier in-life preventative measures to be put in
place to lower their 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 more
'personalised' approach to patient care.
The GENinCode Cardio inCode test is a patent protected in-vitro
diagnostic genomic test system used to assess the risk of onset of
CVD and recurrent myocardial events. The test provides a
comprehensive CVD risk assessment by combining both genetic and
clinical risk factors using GENinCode's proprietary software and
algorithms to produce a personalised CVD risk score. GENinCode
processes and delivers the Cardio inCode-SCORE test via its online
'cloud based' portal to physicians.
Over the past 15 years GENinCode has invested significantly in
its research, bioinformatic data, technology and product
development to assess disease risk to prevent CVD. Using the
predictive capability of genomics, GENinCode has a vision to assist
clinicians and inform patients of their cardiovascular risk and
improve public health.
For more information visit www.genincode.com
GENinCode Plc www.genincode.com or via Walbrook PR
Matthew Walls, CEO
Paul Foulger, CFO
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
Dale Bellis / Michael Johnson (Sales)
Walbrook PR Limited Tel: 020 7933 8780 or email@example.com
Anna Dunphy / Paul McManus / Louis Ashe-Jepson
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, in the United
States through GENinCode U.S. Inc and in Europe through GENinCode
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 disease onset.
About Cardiovascular Disease
Cardiovascular disease (CVD) is 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 and 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.
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.
Cessation of tobacco use, reduction of salt in the diet, eating
more fruit and vegetables, regular physical activity and avoiding
harmful use of alcohol have been shown to reduce the risk of
cardiovascular disease. Health policies that create conducive
environments for making healthy choices affordable and available
are essential for motivating people to adopt and sustain healthy
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.
CVD 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 NHS action on smoking and tobacco
addiction, obesity, tackling alcohol misuse and food
Genetic risk assessment can help early detection and treatment
of CVD to help patients live longer, healthier lives. Many people
are still living with undetected, high-risk conditions such as high
blood pressure, raised cholesterol, and atrial fibrillation (AF).
Progress continues in the NHS to identify and diagnose people
routinely knowing their 'ABC' (testing and monitoring of AF, Blood
pressure and Cholesterol) set out in the NHS 10 Year plan.
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