ROCA® - A New Surveillance Test for Ovarian Cancer

04/11/2024

ROCA® (Risk of Ovarian Cancer Algorithm) is a test for women who are concerned about their risk of developing ovarian cancer.

Each year in Switzerland, more than 600 women are diagnosed with ovarian cancer¹. Women with germline pathogenic variants in BRCA1/2 are at greater risk and identifying those individuals through genetic testing can help mitigate the risk of developing ovarian cancer through preventative interventions and/or surveillance.

When testing positive to a pathogenic variant in BRCA1/2 women can be recommended preventative surgery to remove both ovaries and fallopian tubes; however, this can result in early menopause and loss of fertility. For women that cannot undergo preventative surgery or decide to delay the procedure, the ROCA® test represents a viable surveillance option.

The ROCA® test is typically intended for women between 35 and 85 years with a known pathogenic variant in their BRCA1 or BRCA2 genes, though it can also be administered to women with other ovarian cancer-related variants (e.g., PALB2, BRIP1, RAD51C, RAD51D, MLH1, MSH2, MSH6, EPCAM) and/or women with a high CanRisk score.

The test uses a proprietary algorithm to calculate a woman’s risk of ovarian cancer, which combines changes in the blood levels of Cancer Antigen 125 (CA-125) over four-monthly intervals together with age and other clinical factors. Following a ROCA® test women are classified into three risk categories; Normal, Intermediate, and Elevated risk; based on the risk category, and in coordination with the treating physician, women can be recommended a repeated ROCA test at shorter intervals or a transvaginal ultrasound scan (TVUS) before discussing further options.

ROCA® tests performance and clinical studies

ROCA has been evaluated in multiple clinical studies (the UK Familial Ovarian Cancer Screening Study (UKFOCSS)² and the US/Australian CGN/GOG study³) and in a real-world surveillance program for women with pathogenic germline variants in BRCA1/2 genes (Avoiding Late Diagnosis of Ovarian cancer (ALDO) project⁴).

The ALDO project on a total of 767 women had a sensitivity of ~87.5% (meaning it identified nearly 9 out of 10 women who have ovarian cancer, while missing 1 out 10 women who did have cancer) and a specificity of ~99.9% (meaning hardly any woman without ovarian cancer was incorrectly diagnosed with cancer). The study concluded that, while risk-reducing ovarian surgery remains the recommended procedure, ROCA-based surveillance to detect ovarian cancer before it causes symptoms may be considered for female BRCA-heterozygotes who are deferring such surgery.

Limitations and risks

Risk-reducing bilateral salpingo-oophorectomy (RRSO) is currently the only clinically proven way of preventing ovarian and fallopian tube cancer and is the current recommendation for women at high risk of ovarian cancer. Women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have an ancestry associated with BRCA1/2 gene mutations should not undertake the ROCA® Test unless they have had genetic testing for the presence of BRCA1 or BRCA2 gene mutations.

The ROCA® Test is not 100% accurate and therefore it is still very important to remain aware of the symptoms of ovarian cancer in particular abdominal swelling, and persistent bloating, pelvic or abdominal pain, back pain, difficulty in eating or feeling full quickly, and needing to pass water more urgently or frequently than usual. Women experiencing these symptoms should seek medical advice immediately.

The clinical decision making for patients after interpretation of results of the ROCA® Test is the sole responsibility of the patient’s medical doctor. Guidelines are provided are based on the protocols and outcomes of the UKFOCSS² and CGN/GOG trials³, and the ALDO study⁴, but these recommendations are only a guide and are not a replacement for clinical judgement.

The results of the ROCA® Test are not intended to be used alone to diagnose ovarian cancer. The results from the ROCA® Test must be interpreted in conjunction with independent clinical assessment by a qualified medical doctor. Incorrect use of the ROCA® Test carries the risk of unnecessary testing and surgery. The ROCA® Test is not intended as the sole test to inform the need for surgery. Medical doctors utilising the ROCA® Test should note that a normal transvaginal ultrasound scan (TVUS) in a patient with an abnormal ROCA® Test Result does not exclude ovarian cancer. In such cases, if surgery is not performed, the clinician is strongly encouraged to continue using the ROCA® Test and if the ROCA® Risk continues to rise and a cause is not identified (for example via a CT scan of the chest, abdomen and pelvis), then ovarian cancer should be excluded surgically.

LabNews ROCA® - A New Surveillance Test for Ovarian Cancer

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