TIDMGENI
RNS Number : 1412F
GENinCode PLC
03 November 2022
GENinCode Plc
("GENinCode" or the "Company")
British Medical Journal publication
Study on Avoiding Late Diagnosis of Ovarian Cancer ("ALDO")
Oxford, UK. GENinCode Plc (AIM: GENI), the predictive genetics
company focused on the prevention of cardiovascular disease ("CVD")
and risk of ovarian cancer ("OC"), announces jointly with the
British Medical Journal ("BMJ"), the ALDO publication in the
Journal of Medical Genetics. ALDO is an NHS national pilot
surveillance programme for women with pathogenic germline variants
in BRCA1 and BRCA2 inherited genes. The results showed that
surveillance of OC using the ROCA Test down-stages OC, leading to a
high complete tumour removal rate which improves outcomes for
patients, and is cost-saving in an NHS setting. The ROCA Test is a
blood test that assesses a woman's risk of having ovarian cancer.
The results concluded that whilst preventative surgery remains the
recommended route for BRCA mutation positive women, the ROCA-based
surveillance test may be considered a short-term option for women
deferring such surgery.
The ALDO project is a partnership between the North Central
London Cancer Alliance, and Abcodia Ltd (now owned by GENinCode
Plc). The partnership was formed in 2017 as part of an NHS-industry
challenge to improve the early diagnosis of cancer. The project set
an objective of establishing further clinical evidence for the
performance and cost-effectiveness of OC surveillance using the
ROCA Test, in women with pathogenic BRCA1/2 variants who had
deferred risk-reducing surgery. The proprietary algorithm
calculates a woman's individual OC risk based on a number of
factors including cumulative CA 125 blood test results, age,
menopausal status and the presence of a BRCA1 or BRCA2 gene
mutation. The CA 125 blood test is a widely available across global
healthcare systems offering the prospect of easy adoption of the
algorithm.
875 female BRCA1/2-heterozygotes were recruited through 13 UK
NHS genetic centres, or via an online media campaign, with 767
women undergoing at least one four-month surveillance with the ROCA
Test. Abnormal ROCA results referred women for repeat ROCA Testing
or a Transvaginal Ultrasound Scan (TVUS). Surveillance performance
was calculated by assessing the presence of OC confirmed at
surgery. In an economic analysis, the incremental
cost-effectiveness ratio ("ICER") was also calculated.
During the pilot study, conducted over a 30-month period, eight
OC cases were identified. Six cases were detected by the ROCA Test
and two cases were detected at the point of self-opted risk
reducing surgery. Three of the six (50%) surveillance-detected OC
cases were confirmed through surgery at stages where there was no
visible disease beyond the pelvis. A complete surgical removal of
the tumour was possible in five of six (83%) cases. Modelled
sensitivity, specificity, PPV and NPV for OC were 87.5% (95% CI,
47.3-99.7), 99.9% (99.9-100), 75% (34.9-96.8) and 99.9% (99.9-100)
respectively. The predicted number of quality-adjusted life-years
gained by surveillance was 0.179 with an ICER cost-saving of
-GBP102,496/QALY.
The results showed that OC surveillance for women deferring RRSO
in a 'real-world' setting is feasible and demonstrated similar
performance to the earlier research trials. Surveillance
down-stages OC, which enables a more complete cytoreduction,
therefore improving patient outcomes and is cost-saving in the UK
setting. Whilst preventative surgery remains recommended management
for preventing OC, surveillance with the ROCA Test can be
considered as a short-term option for BRCA-heterozygotes deferring
such surgery.
Click
https://www.bmj.com/company/newsroom/ovarian-cancer-surveillance-in-women-with-faulty-brca-genes-results-in-earlier-stage-diagnosis/
to read the press release from the BMJ.
Matthew Walls, Chief Executive Officer of GENinCode Plc said:
"Following the recent acquisition of the Abcodia business and ROCA
Test, we are delighted with today's publication and the BMJ
announcement of the positive ALDO outcome. Importantly, we hope
that this publication will support NICE as it continues with its
development of comprehensive guidance for women at risk of or
suffering from familial ovarian cancer and enable the NHS to take
advantage of the forecast cost saving benefits."
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 and
Ovarian Cancer, two leading causes 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 Ovarian Cancer
Ovarian cancer is disease that originates in the ovaries, or in
the related areas of the fallopian tubes and the peritoneum. Women
have two ovaries that are located in the pelvis, one on each side
of the uterus. The ovaries make female hormones and produce eggs
for reproduction. Women have two fallopian tubes that are a pair of
long, slender tubes on each side of the uterus. Eggs pass from the
ovaries through the fallopian tubes to the uterus. The peritoneum
is the tissue lining that covers organs in the abdomen. Some
mutations (changes) in certain genes e.g. in BRCA1 and BRCA2 can
increase your risk of developing ovarian cancer.
When ovarian cancer is found in its early stages, long term
survival is improved due to more complete tumour resection and more
effective treatment. Ovarian cancer is difficult to diagnose
through symptom presentation, as the symptoms are vague and present
very often only when the cancer has spread beyond the ovaries.
Ovarian cancer ranks fifth in cancer deaths among women,
accounting for more deaths than any other cancer of the female
reproductive system. The American Cancer Society estimates for
ovarian cancer in the United States for 2022 are:
-- Approximately 19,880 women will receive a new diagnosis of ovarian cancer.
-- Approximately 12,810 women will die from ovarian cancer.
A woman's risk of ovarian cancer during her lifetime is about 1
in 78. Her lifetime chance of dying from ovarian cancer is about 1
in 108. Ovarian cancer mainly develops in older women. About half
of the women who are diagnosed with ovarian cancer are 63 years or
older. It is more common in white women than African American
women. The rate at which women are diagnosed with ovarian cancer
has been slowly falling over the past 20 years.
The ROCA Test offers surveillance for women with a BRCA1 or
BRCA2 mutation who are not ready to undertake risk reducing
surgery. To read more about the ROCA Test, click <here:
www.therocatest.co.uk>
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 and 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.
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