REG - GENinCode PLC - Positive results for Lipid inCode in NHS study

GenincodeAnnouncement

08/02/2022 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20220208:nRSH9462Aa&default-theme=true

RNS Number : 9462A  GENinCode PLC  08 February 2022

GENinCode Plc

("GENinCode" or the "Company")

 

Positive results for Lipid inCode® in NHS clinical study

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
(https://globalcardiologyscienceandpractice.com/index.php/gcsp/article/view/545)
 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 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® 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
(https://globalcardiologyscienceandpractice.com/index.php/gcsp/article/view/545)

 

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
 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

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCTRMRTMTAMBPT