Corporate News

Oxford, UK. GENinCode Plc (AIM: GENI), the predictive genetics company focused on the prevention of cardiovascular disease (“CVD”) and risk of ovarian cancer announces its collaboration with the North Central London (NCL) Cancer Alliance and University College London Hospitals NHS Foundation Trust (UCLH), which becomes the first hospital trust in the UK to provide the Risk of Ovarian Cancer Algorithm (ROCA) surveillance test service as part of its Familial Cancer Clinic. The service, in line with new NICE guidance1, is for women who have a high risk of ovarian cancer due to inherited BRCA1 or BRCA2 gene alterations, who wish to defer preventative surgery.

Women who carry a cancer-causing variant in the BRCA1 or BRCA2 gene have a 44% and 17% respectively in their lifetime risk of ovarian cancer (“OC”) up to the age of 80 years. Around one in every 400 people carries a cancer-causing variant in the BRCA1 or BRCA2 gene. They are advised to undergo surgical removal of their fallopian tubes and ovaries to prevent OC. This remains the safest option for this group of patients. NICE guidance also recommends that surveillance should be offered to women who choose to defer surgery to be able to have children and/or avoid early menopause. UCLH is the first trust in the country to offer this surveillance on the NHS, outside of a trial setting.

The ROCA Test’s proprietary algorithm calculates a woman’s individual risk based on several clinical factors. These include cumulative Cancer Antigen 125 (CA 125) blood test results, age, menopausal status and the presence of a BRCA1 or BRCA2 gene alteration. Having the ROCA blood test every four months improves the chances of early detection of ovarian cancer (pre-stages III and IV). Early detection improves treatment outcomes.

Three key prospective studies have been conducted using the ROCA Test with women at high-risk of OC. The first UK study UKFOCSS was led by University College London (UCL). Based on the reduction in late-stage ovarian cancer seen in this trial, a ‘real world’ NHS implementation study, ALDO was initiated to assess the feasibility of ROCA surveillance in the NHS and to conduct an economic analysis. Based on these data, and a further US study, which together report a 44% reduction in late-stage ovarian cancer detections (stage III and IV), the NICE committee concluded that the ROCA Test is the preferred method of surveillance for women deferring preventative surgery. Economic analysis also indicates a cost saving to the NHS.

Professor Adam Rosenthal, Consultant Gynaecologist at UCLH said: “Having pioneered the clinical trials in this area, we have reached a significant milestone in being able to offer ROCA surveillance for high-risk women in our NHS Familial Cancer Clinic. The service will give women with BRCA1 or BRCA2 gene alterations a surveillance option if they want to complete their families or defer preventive surgery for other reasons.”

Ali Malik, Managing Director of the NCL Cancer Alliance said: “After supporting the ALDO study to prove the viability of the using the ROCA Test, we are proud to help UCLH establish this service. For the first time it will empower all eligible women across North Central London who are not ready to undergo cancer prevention surgery. Surveillance means that their ovarian cancer risk will be closely monitored and hence mitigate the risk of being diagnosed at the most advanced stages. This step forward highlights the Cancer Alliance’s distinctive role in initiating, evaluating, and embedding innovative approaches into clinical practice.”

Matthew Walls, Chief Executive Officer, GENinCode Plc said: “We are delighted to have worked closely with UCLH and the North Central London Cancer Alliance to deliver this first NHS ROCA surveillance service for women at high-risk of ovarian cancer. It has required a significant effort from the cross-functional teams involved and we are grateful for their determination and focus. We look forward to extending the ROCA Test implementation to other NHS trusts in due course.”

1. NICE Guidance NG241 Ovarian cancer: identifying and managing familial and genetic risk https://www.nice.org.uk/guidance/ng241

 

For more information visit www.genincode.com

Enquiries:

GENinCode Plc	www.genincode.com or via Walbrook PR
Matthew Walls, CEO
Cavendish Capital Markets Limited	Tel: +44 (0)20 7397 8900
Giles Balleny/ Trisyia Jamaludin (Corporate Finance)
Nigel Birks (Life Sciences Specialist Sales)
Harriet Ward (Corporate Broking)
Walbrook PR Limited Anna Dunphy / Paul McManus / Marcus Ulker	Tel: 020 7933 8780 or genincode@walbrookpr.com

 

About GENinCode:
GENinCode Plc is a UK based company specialising in genetic risk assessment of cardiovascular disease and ovarian cancer. Cardiovascular disease is the leading cause of death and disability worldwide. GENinCode operates business units in the UK, Europe through GENinCode S.L.U., and in the United States through GENinCode U.S. Inc. GENinCode predictive technology provides patients and physicians with globally leading preventive care and treatment strategies. GENinCode invitro-diagnostic molecular tests combine clinical algorithms and AI bioinformatics to advance patient risk assessment to prevent the onset of cardiovascular disease and ovarian cancer. For more information, visit www.genincode.com and for the ROCA Test, www.therocatest.co.uk 

Notes to editors

1. Referral process

The UCLH Familial Cancer Clinic accepts referrals for patients with proven inherited gene alterations living in North Central London, via regional Clinical Genetics Services or from other sources e.g. breast teams and primary care. Breast and ovarian cancer patients are now routinely tested for inherited BRCA variants. If a BRCA variant is identified then direct (blood) relatives will be invited for a call with a genetics counsellor to discuss genetic testing. GPs can refer patients to the regional genetics service for testing according to the criteria in NICE Guideline 241.

2. UCLH (University College London Hospitals NHS Foundation Trust) provides first-class acute and specialist services in six hospitals in Central London. UCLH is committed to education and research and forms part of UCLPartners which in March 2009 was officially designated as one of the UK's first academic health science centres by the Department of Health. UCLH works closely with UCL, translating research into treatments for patients. For more information visit www.uclh.nhs.uk. Facebook (UCLHNHS), X/Twitter (@uclh), Youtube (UCLHvideo) and instagram (@uclh).

3. NHS North Central London Cancer Alliance works together with partners to improve the lives of people affected by cancer across North Central London. It does this through clinical and technological innovation, a supported and knowledgeable workforce, and clear action to tackle health inequalities. www.nclcanceralliance.nhs.uk