REG - GENinCode PLC - FDA Pre-Submission for Cardio inCode-SCORE

GenincodeAnnouncement

10/01/2022 07:05

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RNS Number : 8369X  GENinCode PLC  10 January 2022

10 January 2022

GENinCode Plc

("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 disease ("CVD").

 

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 (http://www.genincode.com)

Enquiries:

 GENinCode Plc                          www.genincode.com (http://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
 Giles Balleny
 Dale Bellis / Michael Johnson (Sales)

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

 Anna Dunphy / Paul McManus / 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, in the United States through
GENinCode U.S. Inc and in Europe through GENinCode S.L.U.

 

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
behaviours.

 

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
reformulation.

 

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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