REG - GENinCode PLC - CARDIO InCode CPT PLA Code

GenincodeAnnouncement

03/04/2023 07:00

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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 (https://youtu.be/mB7xgRcpgsc)

 

 

 

 

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

 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

                                                             (mailto: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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