TIDMGENI
RNS Number : 9462A
GENinCode PLC
08 February 2022
GENinCode Plc
("GENinCode" or the "Company")
Positive results for Lipid inCode(R) in NHS clinical study
Lipid inCode(R) offers greater diagnostic information for
hypercholesterolemia sufferers over current NHS standard
Oxford, UK. GENinCode Plc (AIM: GENI), the predictive genetics
company focused on the prevention of cardiovascular disease,
announces the successful completion of its NHS clinical study and
positive results for its Lipid inCode(R) test ("Lipid inCode(R)")
for hypercholesterolemia (high levels of cholesterol), including
Familial Hypercholesterolemia (FH), undertaken at Royal Brompton
and Harefield Hospitals ("RB&H"), recently merged with Guy's
and St Thomas' NHS Foundation Trust ("GSTT") the largest specialist
heart and lung centre in the UK.
Piers McCleery, Director of strategy, RB&H hospitals: " The
study results mark a breakthrough for hypercholesterolemia
sufferers and preventative care practice and we are delighted that
the Lipid inCode test can help support the NHS 10-Year plan to
identify and address patients suffering with Familial
Hypercholesterolemia."
The peer reviewed study, which has been published in Global
Cardiology Science and Practice [1] , involved DNA samples from 40
index cases who had been referred for FH testing in an
ISO15189-accredited NHS genetic screening service. These samples
were then retrospectively tested using the Lipid inCode(R) assay
with the results compared with those from the initial NHS
testing.
The positive results showed an " absolute concordance in variant
detection between both diagnostic tests for monogenic and polygenic
FH, the only difference being in the interpretation and
classification of DNA variants based on ACMG guidelines, which did
not differ by more than one classification class. " The Lipid
inCode(R) test was "equivalent to the NHS test in providing
comprehensive genetic analysis that included the assessment of both
monogenic (FH) and polygenic determinants of blood cholesterol and
including a pharmacogenomic assessment of predisposition to
statin-related myopathy".
The study concluded that "the Lipid inCode(R) diagnostic test
can be undertaken with rapid turnaround and gave the same results
as those reported by standard NHS genetic laboratory testing." This
is expected to increase diagnostic efficiency and support timely
clinical management. Furthermore, the study found that Lipid inCode
(R) offers additional genetic information such as a polygenic risk
score (PRS) for hypercholesterolemia, pharmacogenomic testing for
statin intolerance, and genetic predisposition to raised Lp(a), an
important independent cardiovascular risk factor. Lipid inCode(R)
also provides a coronary Genetic Risk Score which indicates the
genetic contribution to an individual's overall risk of future
coronary heart disease events, based on the genetic variants
analysed.
In the UK around 7.6m people are living with heart and
circulatory disease causing 25% of all deaths annually in the UK.
Cardiovascular disease (CVD) can be reduced by diagnosing and
treating individuals at risk, and the NHS 10 Year Plan (2019) sets
out significant ambitions to address the prevention of CVD,
including identifying individuals with hypercholesterolemia and
particularly those with FH. Lipid inCode offers genetic testing for
the causes of high cholesterol, with rapid results and a
comprehensive report to clinicians. Lipid inCode(R) will be offered
at a reduced cost to the NHS to help support the NHS meet its
declared ambition to detect 25% of people with FH by 2024.
Familial Hypercholesterolemia is an inherited monogenic
condition which affects an individual's ability to regulate and
remove cholesterol from their blood. FH affects approximately 1 in
250 people in the UK population and globally. The NHS Long Term
Plan sets out to expand access to genetic testing for FH, which
causes early heart attacks and sudden cardiac death. Individuals
suffering with FH have a higher risk of heart disease and death at
a younger age. For individuals suffering with FH it is important to
lower their cholesterol to healthy levels as early as possible,
often requiring medicines such as statins or more aggressive
treatment to help better control cholesterol levels.
GENinCode specialises in polygenic assessment to identify those
at risk of developing CVD, with the aim of preventing future
cardiovascular events. CVD is a broad disease classification which
encompasses conditions such as coronary artery disease (causing
angina, heart attacks, heart failure), cerebrovascular disease
(causing stroke, and some dementia), peripheral vascular disease
(causing limb ischemia, and some chronic kidney disease) and venous
thromboembolism. CVD is the leading cause of death and disability
worldwide accounting for one in every four deaths in the United
States. According to the US National Institutes of Health (NIH), by
2030, the global cost of CVD is set to rise to US$1,044 billion,
from approximately US$863 billion in 2010, and is both a major
health issue and global economic burden.
GENinCode and RB&H have a shared vision to assist clinicians
and inform patients in interpreting cardiovascular risk, and to
improve public health using the predictive capability of genomics.
High genetic risk patients are assisted in making lifestyle choices
and can receive targeted treatment to improve outcomes. Over the
past 15 years GENinCode has made a substantial investment in its
research, bioinformatic data, technology, and product development
to assess disease risk, in order to help clinicians and patients
prevent the onset of CVD.
Matthew Walls, CEO, GENinCode said: "We are delighted with the
published results and what this will mean to patients suffering
with dyslipidemia and familial hypercholesterolemia in the UK. The
results further strengthen our ability to deliver significant
clinical improvement in the diagnosis of hypercholesterolemia and
will help support the NHS reach its goals to diagnose patients with
hypercholesterolemia and personalise treatment to prevent the onset
of CVD."
'Evaluation of a novel rapid genomic test including polygenic
risk scores for the diagnosis and management of familial
hypercholesterolaemia' by Neves, E. et al. Global Cardiology
Science & Practice, No 4 (2021), DOI: 10.21542/gcsp.2021.31,
https://globalcardiologyscienceandpractice.com/index.php/gcsp/article/view/545
For more information visit www.genincode.com
Enquiries:
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 genincode@walbrookpr.com
Anna Dunphy / Paul McManus / Louis Ashe-Jepson
About GENinCode:
GENinCode Plc is a UK based company specializing 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 Royal Brompton and Harefield hospitals and Guy's and St
Thomas' NHS Foundation Trust:
Royal Brompton and Harefield Clinical Group, part of Guy's and
St Thomas' NHS Foundation Trust since February 1(st) , 2021, is the
largest specialist heart and lung centre in the UK and among the
largest in Europe. Clinical teams at the RB&H care for patients
with a wide range of complex cardiac conditions including
congenital (present at birth), inherited, and acquired.
Guy's and St Thomas' NHS Foundation Trust (GSTT) is one of the
largest hospital Trusts in the UK. RB&H's Genetics &
Genomics Laboratory provides specialist cardiovascular and
respiratory clinical genetic testing as part of the South London
Genomics Laboratory Hub consortium, which is led by GSTT. As a
clinical group within GSTT, RB&H is also a member of the South
East Genomic Medicine System Alliance.
About Cardiovascular Disease (CVD):
Heart and circulatory disease, also known as 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 NHS action on smoking and tobacco
addiction, obesity, tackling alcohol misuse and food
reformulation.
Early detection and treatment of CVD can 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' (AF, Blood pressure and Cholesterol).
[1]
https://globalcardiologyscienceandpractice.com/index.php/gcsp/article/view/545
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