REG - GENinCode PLC - Approval of California state license

GenincodeAnnouncement

03/01/2023 07:00

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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® and
LIPID inCode®, which can now to be sold across the US and serviced from the
Company's California CLIA lab.

 

CARDIO inCode® measures an individuals inherited genetic risk of coronary
heart disease with the complementary FDA 510K submission for a CARDIO inCode®
kit (for use by other CLIA labs) to be filed shortly. LIPID inCode® 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® and LIPID inCode® 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® 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 (http://www.genincode.com)

 

 GENinCode Plc                              www.genincode.com (http://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 (mailto: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
(https://wonder.cdc.gov/mcd-icd10.html) . 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 (https://doi.org/10.1161/cir.0000000000001052)
. 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
(https://meps.ahrq.gov/mepsweb/data_stats/download_data_files.jsp) . Accessed
April 8, 2021.

 

 

 

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