TIDMGENI
RNS Number : 0394V
GENinCode PLC
03 April 2023
GENinCode Plc
("GENinCode" or the "Company")
US CPT PLA Code Granted for CARDIO inCode-SCORE (CIC-SCORE)
CPT PLA Code is key component for reimbursement from private
medical insurance and Medicare
Oxford, UK. GENinCode Plc (AIM: GENI), the genetics company
focused on the prevention of cardiovascular disease ("CVD"),
announces the Amercian Medical Asscoiation (AMA) grant of a Current
Procedural Terminology (CPT) Proprietary Laboratory Analyses (PLA)
code for its CARDIO inCode-SCORE ("CIC-SCORE") polygenic test for
the risk assessment of Coronary Heart Disease. The new code 0401U,
has been approved and published by the AMA CPT Editorial Panel(1)
and is scheduled to become effective on July 1(st) 2023.
A payment rate for the new code will be established for Medicare
patients through the Clinical Lab Fee Schedule (CLFS) Annual Public
Meeting process. GENinCode will commence discussions with Medicare
and recommend an appropriate basis for establishing a national
Medicare price for the CIC-SCORE code.
CIC-SCORE is entering Early Access Programs with leading
institutions in the United States over the coming months and the
grant of the CPT PLA code is an important step in preparing
CIC-SCORE for insurance coverage and reimbursement. The CPT Code
will enable increased access to the CIC-SCORE test for patients at
genetic risk of Coronary Heart Disease.
The grant of the CPT PLA code follows an extensive program of
work to gain California State Licensing and CLIA approval for the
CIC-SCORE test at the Company's Irvine, CA Laboratory together with
the clinical and analytical validation of the CIC-SCORE lab
diagnostic test. CPT coding and terminology is widely used across
the United States providing doctors and health care professionals
with a uniform language for coding medical services and procedures
to streamline reporting, increase accuracy and efficiency.
CIC-SCORE is a in-vitro diagnostic test used to assess an
individuals inherited (DNA) genetic risk of Coronary Heart Disease.
The test is based on published clinical evidence amassed over the
past 15 years and combined with traditional clinical risk provides
a comprehensive risk assessment of Cardiovascular Disease (CVD) for
use in primary preventative care. GENinCode processes and delivers
the CARDIO inCode-SCORE test to physicians via its online 'SITAB'
cloud based reporting system.
CIC-SCORE also addresses the well-recognised need for
improvement in the CVD standard of care. The CIC-SCORE test
provides an improved estimation of an individual's risk of heart
attack over their lifetime and particularly within a 10-year period
following the test. CIC-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.
GENinCode specialises in polygenic risk assessment of CVD, the
leading cause of death and disability worldwide.
Matthew Walls, CEO of GENinCode PLC said: "The grant of the CPT
PLA code is an important step as we prepare CARDIO inCode-SCORE to
enter Early Access Programs in the United States. The code is
instrumental to obtaining insurance coverage and reimbursement, and
will help increase access to CARDIO inCode-SCORE testing for
patients at genetic risk of Coronary Heart Disease."
1. https://youtu.be/mB7xgRcpgsc
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 and accounts for 1 in every
4 deaths 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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