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GenincodeAnnouncement

03/11/2022 07:00

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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 -£102,496/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/
(https://urldefense.proofpoint.com/v2/url?u=https-3A__www.bmj.com_company_newsroom_ovarian-2Dcancer-2Dsurveillance-2Din-2Dwomen-2Dwith-2Dfaulty-2Dbrca-2Dgenes-2Dresults-2Din-2Dearlier-2Dstage-2Ddiagnosis_&d=DwMFaQ&c=euGZstcaTDllvimEN8b7jXrwqOf-v5A_CdpgnVfiiMM&r=qE1yMNvX8OUmO7FV4SLAuFx81K4O8nrPcCbRUEpXKXA&m=ttXaE_ZHgI2NlokcH9bZQjDeyeCBZZIndiZ0oWiScNQ&s=XmZ6Od9453ZYN2q9KQ78psbHCgGvHriYa8iXBo44vlk&e=)
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 (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 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 

 

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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