TIDMGENI
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, t
he 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
Enquiries:
GENinCode Plc 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
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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