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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 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.”

Find out more about the NICE Guidelines