Positive results for Lipid inCode® in NHS clinical study
08 February 2022
Lipid inCode® 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® test (“Lipid inCode®”) 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 Practice1, 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® 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® 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® 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® 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® 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® 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 |
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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 |
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Giles Balleny | |||
Dale Bellis / Michael Johnson (Sales) | |||
Walbrook PR Limited Anna Dunphy / Paul McManus / Louis Ashe-Jepson |
Tel: 020 7933 8780 or genincode@walbrookpr.com |
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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 1st, 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).