TIDMGENI
RNS Number : 4032L
GENinCode PLC
03 January 2023
GENinCode Plc
("GENinCode" or the "Company")
Approval of California state license and CLIA certification
opens US market
Oxford, UK. GENinCode Plc (AIM: GENI), the predictive genetics
company focused on the prevention of cardiovascular disease
("CVD"), announces California state licensing approval and CLIA
certification of its Irvine laboratory in California, enabling the
provision of its products for the risk assessment of CVD to
patients across 49 states in the United States.
The approval of the California state license by the California
Department of Public Health and CLIA certification from the Centers
for Medicare and Medicaid Services (CMS) marks a major milestone in
the commercialisation of the Company's 'first in class' polygenic
CVD products CARDIO inCode (R) and LIPID inCode (R) , which can now
to be sold across the US and serviced from the Company's California
CLIA lab.
CARDIO inCode (R) measures an individuals inherited genetic risk
of coronary heart disease with the complementary FDA 510K
submission for a CARDIO inCode (R) kit (for use by other CLIA labs)
to be filed shortly. LIPID inCode (R) measures an individuals
inherited genetic inability to metabolise LDL-C cholesterol (LDL-C
is often referred to as 'bad cholesterol') giving rise to
accelerated onset of heart disease. CARDIO inCode (R) and LIPID
inCode (R) are now being prepared for entry into Early Access
Programs with US revenue growth forecast from 2023.
According to the US Centres for Disease Control (CDC), heart
disease is the leading cause of death for men, women, and people of
most racial and ethnic groups in the United States.(1) One person
dies every 34 seconds in the United States from cardiovascular
disease.(1) About 697,000 people in the United States died from
heart disease in 2020 - which is one in every five deaths.(1,2)
Heart disease cost the United States about $229 billion each year
from 2017 to 2018.(3) This includes the cost of health care
services, medicines, and lost productivity due to death.
CARDIO inCode (R) measures the coronary genetic risk of a
patient suffering a heart attack or cardiovascular event. This new
genetic information allows physicians to gain insight to a
patient's coronary genetic risk score allowing more effective and
earlier treatment to prevent heart disease. Physicians can now
advise patients on their genetic risk of a coronary event and
establish necessary changes to their lifestyle (e.g. reducing
smoking, drinking or improving eating habits) as well as
prescribing therapeutic treatment (e.g. statins, PCSK9i or other
cholesterol lowering drugs) to prevent heart disease.
Matthew Walls, Chief Executive Officer of GENinCode Plc said:
"The approval of the California state license and CLIA
certification enables us to begin to sell our products across the
US market. There has been a tremendous work effort to deliver these
approvals representing a major advance in the Company's commercial
programme. We continue to work closely with our US partner
collaborators on launch planning and advancing our Early Access
Programs in preparation for commencement of US revenues in
2023."
For more information visit www.genincode.com
GENinCode Plc 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
Anna Dunphy / Louis Ashe-Jepson / Phillip Marriage genincode@walbrookpr.com
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 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.
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.
Coronary heart disease (CHD) is the most common type of heart
disease in the US, killing 382,820 people in 2020. About 20.1
million adults age 20 and older have CHD (about 7.2%).(2) In 2020,
about 2 in 10 deaths from CHD happen in adults less than 65 years
old.(2) Early Action Is Important for Heart Attack.
In the US, someone has a heart attack every 40 seconds.(2) Every
year, about 805,000 people in the US have a heart attack.(2) Of
these,
o 605,000 are a first heart attack(2)
o 200,000 happen to people who have already had a heart
attack(2)
o About 1 in 5 heart attacks are silent -the damage is done, but
the person is not aware of it.(2)
References
1. Centers for Disease Control and Prevention, National Center
for Health Statistics. About Multiple Cause of Death, 1999-2020 .
CDC WONDER Online Database website. Atlanta, GA: Centers for
Disease Control and Prevention; 2022. Accessed February 21,
2022.
2. Tsao CW, Aday AW, Almarzooq ZI, Beaton AZ, Bittencourt MS,
Boehme AK, et al. Heart Disease and Stroke Statistics-2022 Update:
A Report From the American Heart Association . Circulation.
2022;145(8):e153-e639.
3. Agency for Healthcare Research and Quality. Medical
Expenditure Panel Survey (MEPS): household component summary
tables: medical conditions, United States . Accessed April 8,
2021.
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