TIDMGENI
RNS Number : 5122J
GENinCode PLC
16 August 2023
GENinCode Plc
("GENinCode" or the "Company")
Premarket Notification 510(k) medical device filing for CARDIO
inCode-Score (CIC-SCORE)
510(k) approval will enable US expansion and 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 filed its Premarket Notification (510k) with the
Food and Drug Administration (FDA) to expand its US commercial
distribution of the CARDIO inCode-Score ("CIC-SCORE") polygenic
test for the risk assessment and prevention of Coronary Heart
Disease ("CHD").
CIC-SCORE is a in-vitro diagnostic test used to assess an
individual's polygenic risk of CHD based on DNA analysis. The test
is based on published clinical evidence amassed over the past 15
years which combined with traditional clinical risk provides a
comprehensive risk assessment of CHD for use in primary
preventative 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 step change in patient risk
assessment for CHD thereby improving preventative care, patient
management, and personalised treatment.
GENinCode has commenced Early Access Programs for CIC-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 approved laboratory in Irvine, California. The Company expects
to receive FDA approval of the premarket notification for the
CIC-SCORE kit/medical device over the next 6 months enabling scale
up and processing by CLIA labs across the United States.
The Company also announces that it has received the College of
American Pathologist ("CAP") laboratory accreditation for the
CIC-SCORE test delivered from the Company's US laboratory based in
Irvine, California. This follows receipt of California State
Licensing and CLIA approval earlier this year.
The 510k filing follows the recently announced CPT PLA code
(0401U) for CIC-SCORE which was approved and published by the AMA
CPT Editorial Panel. A payment rate for the new code will be
established for Medicare patients through the Clinical Lab Fee
Schedule ("CLFS") Annual Public Meetings with a pricing decision on
CIC-SCORE expected in October.
Matthew Walls, CEO of GENinCode PLC said: "Approval of the 510k
kit/medical device filing will complement our US laboratory testing
enabling GENinCode to accelerate commercial growth of CIC-SCORE in
the US market. Our Early Access Program is seeing strong demand for
use of our CIC-SCORE CLIA lab test to identify patients at high
genetic risk, personalise treatment and prevent CHD."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014, as it forms part of
domestic law by virtue of the European Union (Withdrawal) Act 2018.
The person responsible for arranging the release of this
announcement on behalf of GENinCode Plc is Matthew Walls, Chief
Executive Officer.
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 / 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 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 (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
preventative approach to CVD.
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