Genincode Regulatory News (GENI)

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] 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

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