REG - GENinCode PLC - New NICE Guidance for Ovarian Cancer

GenincodeAnnouncement

21/03/2024 11:00

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RNS Number : 8041H  GENinCode PLC  21 March 2024

 

This announcement contains inside information for the purposes of Article 7 of
Regulation (EU) 596/2014, as it forms part of domestic law by virtue of the
European Union (Withdrawal) Act 2018. The person responsible for arranging the
release of this announcement on behalf of GENinCode Plc is Matthew Walls,
Chief Executive Officer.

 

 

GENinCode Plc

("GENinCode" or the "Company")

 

New NICE Guidance for Ovarian Cancer

Surveillance using the ROCA test is now an option for individuals at high risk
of ovarian cancer

 

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 that its Risk of Ovarian Cancer Algorithm ("ROCA") test, has
received a National Institute for Health and Care Excellence ("NICE")
recommendation as the preferred test for OC surveillance in individuals at
high risk of ovarian cancer who do not undertake risk reducing surgery. The
new NICE guidance 1  (#_ftn1) is focused on identifying and managing familial
and genetic risk of OC.

 

Each year in the UK, 7,500 women are diagnosed with OC and over half of those
will die from the disease. The risk of developing OC is particularly high in
individuals who inherit a known pathogenic variant in certain genes such as
BRCA1 or BRCA2. It is estimated that up to 170,000 people in the UK may be
carriers of a BRCA gene variant. Identifying such individuals through genetic
testing will allow the NHS to better mitigate that risk through prevention
and/or surveillance.

 

Preventative surgery to remove both ovaries and fallopian tubes is the
standard of care but where this is not possible, or where the patient decides
to delay surgery, NICE now recommends that individuals can be offered
surveillance using the ROCA test. The NICE committee reviewed various
surveillance protocols, as published in the peer reviewed literature, and
concluded that the ROCA test was the most accurate with the best detection
rate for earlier stages of OC (stage IIIa or lower). Detection of OC at an
earlier stage is associated with a better prognosis and treatment.

 

The ROCA test uses a proprietary algorithm to calculate a woman's individual
OC risk based on several clinical factors including age and accumulating
Cancer Antigen 125 (CA-125) blood test results. The ability of the ROCA test
to interpret changes in an individual's CA-125 level over time through four
monthly interval testing was recognised by the NICE committee as an important
contributor to its accuracy and ability to detect OC earlier. Additionally,
the NICE committee recognised the published evidence that surveillance using
the ROCA test would have a cost-saving benefit for the NHS.

 

Matthew Walls, Chief Executive Officer of GENinCode Plc, said: "Today's
publication of NICE guidance is an important milestone for the ROCA test.
After many years of academic and corporate investment, the ROCA test has been
comprehensively assessed by NICE as the surveillance technology of choice
where patients at high risk of familial OC decide to defer preventative
surgery. Surveillance using the ROCA test will help individuals feel more
supported while they start or grow their families or until they reach
menopause, whilst also providing a cost-saving benefit for the NHS. The
GENinCode team will now assist the NHS to help establish appropriate call and
recall systems that will enable the ROCA test to be offered by the NHS to all
eligible individuals."

 

1.        Project information | Ovarian cancer; identifying and
managing familial and genetic risk |Guidance|NICE

 

 

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

 Cavendish Capital Markets Limited                                               Tel: +44 (0)20 7397 8900
 Giles Balleny /Dale Bellis / Michael Johnson

 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 and risk of ovarian cancer, two of the 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.

 

Ovarian cancer ranks fifth in cancer deaths among women, accounting for more
deaths than any other cancer of the female reproductive system. Cancer
Research UK estimates for ovarian cancer in the United Kingdom are:

 

·      Approximately 7,500 women will receive a new diagnosis of ovarian
cancer per year.

·      Approximately 4,140 women will die from ovarian cancer.

 

A woman's risk of ovarian cancer during her lifetime is about one in 56. It is
more common in white women than African American women. The risk of ovarian
cancer increases with age, with most cases occurring in women over 60.
However, having a family history of ovarian cancer or being of Ashkenazi
Jewish descent may point to an individual carrying a genetic variant in one of
several genes e.g. in BRCA1 and BRCA2 that are known to increase ovarian
cancer risk. Up to 20% of ovarian cancer is due to genetic causes.

 

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.

 

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, see www.therocatest.com (http://www.therocatest.com)

 

(#_ftnref1)

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