Partnership with Genesupport SA for the ROCA® Test

GENinCode Plc

("GENinCode" or the "Company")

GENinCode partners with Genesupport SA for the ROCA® Test in Switzerland

Ovarian cancer surveillance using the ROCA Test to be made available to individuals across Switzerland

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 its partnership with Genesupport SA, part of the Sonic Switzerland network of laboratories, to enable country-wide access to the ROCA® Test.

In March 2024, the ROCA Test 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 wish to defer risk-reducing surgery.¹ Based on this milestone, Genesupport SA will make the ROCA Test available through all Sonic Switzerland diagnostic and genetic companies, including Genesupport, Medigenome Medisupport, Medica, Medisyn, and Dr Risch. These companies cover all major Swiss cities (Geneva, Lausanne, Bern and Zurich), and regional centers (e.g. St. Gallen, Zug, Lucerne, Lugano/Locarno). Genesupport is also affiliated with the major tumour centres and hospital groups across the country (e.g. Hirslanden and Swiss Medical Network). Genesupport will offer the test under the ROCA brand in Switzerland, to women who are BRCA positive and have not undertaken risk reducing surgery, with the test supporting an eligible population of more than 11,000 women at high risk of OC.

Each year there are over 300,000 new cases of OC globally 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 BRCA2.² Such mutations occur in up to 0.4% of the general population and up to 3% of individuals of Jewish descent. Identifying such individuals through genetic testing will allow healthcare professionals to better mitigate that risk through preventive surgery and/or surveillance.

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 ROCA Test has many years of clinical evaluation through prospective studies³ which have proven its high accuracy and ability to detect OC earlier. Earlier detection improves treatment outcomes.

Matthew Walls, Chief Executive Officer of GENinCode Plc, said: "We are delighted to partner with Genesupport to allow access to the ROCA Test in the Swiss market. After many years of academic and corporate investment, the ROCA test is now lifting the standard of care for patients at high risk of familial ovarian cancer who decide to defer preventive surgery. Surveillance using the ROCA test will help individuals feel more supported while they start or build their families or until they are ready to undertake surgery."

Bernard Conrad, Chief Medical Officer of Genesupport, said: "Offering the ROCA Test throughout the Sonic Switzerland network synergises well with our other services in the field of genetic testing and women's health. Based on the evidence that has accrued over many years, the ROCA Test is recognised as the best in class and is an important test to be able to offer women who face difficult choices in managing their familial ovarian cancer risk."

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

² BRCA1, BRCA2, MLH1, MSH2, MSH6, RAD51C, RAD51D, BRIP1 and PALB2

³ Rosenthal, AN, et al. J. Clin. Oncol. 35(13): 1411-1420, 2017; Skates, SJ, et al. Clin. Cancer Res. 23(14): 3628- 3637, 2017; Philpott, S et al. J Med Genet. 60(5):440-449, 2023.

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 preventive 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 Genesupport SA

Genesupport SA offers a complete healthcare service in the field of prenatal, paediatric and adult human genetics: it has multidisciplinary competence combining molecular genetics, conventional and molecular cytogenetics, and cytogenomics. Genesupport's genetics centre occupies two sites, in Lausanne and Geneva, Switzerland.

Along with its medical genetics work, Genesupport offers customised genetic counselling, provided by Swiss Medical Association (FMH) specialists in medical genetics and qualified counsellors trained in medical genetics. Genesupport also provides DNA sequencing and bioinformatics services for researchers worldwide. This work is undertaken in its "Life Science" division under the Fasteris brand name.

About Ovarian Cancer

Ovarian cancer is a 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. The World Cancer Research Fund International estimates for ovarian cancer in the worldwide are:

·      Approximately 324,603 women will receive a new diagnosis of ovarian cancer per year.

·      Approximately 206,956 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.

ROCA® (Risk of Ovarian Cancer Algorithm) is a registered trademark of GENinCode Plc in the UK, European Union and in the United States

To read more about the ROCA Test, see www.therocatest.co.uk