What is the ROCA® Test?
The ROCA Test is a simple blood test that detects the likelihood of a woman having ovarian cancer.
The ROCA Test uses a woman’s age, menopausal status, risk status and serial blood measurements of CA-125 to produce a score that indicates her chances of having ovarian cancer. It has been rigorously tested in a 15-year trial involving over 200,000 women and proven to more accurately detect ovarian cancer earlier than other tests1.
The ROCA Test is the only test for the earlier detection of ovarian cancer that has been evaluated in major clinical trials and shown to be significantly more accurate than the CA-125 blood test. The ROCA Test uses your CA-125 measurements, establishing your baseline levels of CA-125 to reveal an individualized profile of change over time rather than relying on a single CA-125 fixed cutoff value.
Eligibility and Risk for Ovarian Cancer
You may be eligible for the ROCA Test if you are:
- Between 50 and 85 years and have been through menopause
- Between 35 and 85 years with any of the following:
- A known mutation in the BRCA1 or BRCA2 genes and/or Lynch syndrome
- A known family history of ovarian and/or breast cancer
- Relatives of Ashkenazi Jewish descent
You should talk with your doctor about whether the test is right for you based on your personal and family health history.
If several members of your family have had ovarian and/or breast cancer (including male breast cancer), you may be classed as having a family history of these cancers. However, your history will also depend on your ethnicity and other factors. To understand your risk of ovarian cancer you should make an appointment to speak with your clinician who will review your medical history and determine if you have a family history that may increase your risk of ovarian cancer.
Removal of the ovaries is one option for women with BRCA mutations. Although the ROCA Test could be a short term alternative to delay this surgery, we recommend you consult your doctor if you wish to explore other options.
No, patients who have had ovarian cancer do not meet the criteria for the ROCA Test.
No, patients who are pregnant are not eligible to take the ROCA test. You may resume testing 6 weeks after the end of your pregnancy.
Yes, but it is recommended to wait until 12 months after starting HRT for menopausal symptoms before starting the ROCA Test.
Women who have had both of their ovaries removed, but still have their fallopian tubes, do not meet the criteria for the ROCA Test unless they are aged 35-85 and are at high risk for ovarian cancer.
The ROCA test was evaluated in a 15-year clinical trial in this population of women. Patients who were part of the general population and were not between the ages of 50-85 years or were not postmenopausal, were not included in the study.
The ROCA Test was evaluated in a 4 year study in this population of women considered to be at high risk of ovarian cancer. Those who were not between 35-85, were not included in the study.
A woman is considered to be postmenopausal when she has not had her period for 12 months or after 12 months of starting HRT for menopausal symptoms.
Taking the ROCA Test
How frequently you should have the ROCA Test will be determined by your clinician based on your risk factors for ovarian cancer as well as your test results:
- If you are not at high risk of ovarian cancer and your results are Normal, you will likely have one test per year
- If you are at high risk for ovarian cancer, you will likely have three tests a year
If your results are not Normal, your clinician may recommend a repeat ROCA Test within the next six weeks to three months. You may also be referred for a transvaginal ultrasound (TVUS) scan of your ovaries or other clinical assessment determined by your clinician.
You can always start taking the ROCA Test again, even if you have stopped for a period of time. Discuss this with your clinician
No, you do not have to have the ROCA test on the exact same day annually but we recommend you aim to have the test as your clinician advises.
- A numerical score (e.g., 1 in 5000)
- A categorisation (Normal, Intermediate or Elevated)
If your ROCA Test result is outside of the Normal range (Intermediate or Elevated) at any time during screening it does not mean that you definitely have ovarian cancer. Your clinician may ask you to take a repeat ROCA Test within the next six weeks to three months, refer you for a transvaginal ultrasound (TVUS) scan of your ovaries, or suggest other possible clinical assessments.
The ROCA Test works by tracking your baseline CA125 level and accurately assessing change. Each time you have the test, all previous CA125 test results are used. Also, ovarian cancer can develop rapidly so regular testing is recommended.
The Risk of Ovarian Cancer Algorithm (ROCA) has been evaluated over a 15-year period, in a major trial known as The United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS), which involved over 200,000 postmenopausal women from across the UK.
The results of this trial demonstrated that ROCA, when used with a transvaginal ultrasound scan as the follow-up test, detected 85 out of every 100 women with ovarian cancer, and ruled out cancer in over 99% of women did not have the disease. The trial also showed that screening picked up more early stage ovarian cancer than no screening
The ROCA Test was also evaluated in a trial called UK Familial Ovarian Cancer Screening Study (UKFOCSS), in which over 4,300 women with a mutation in the BRCA1 or BRCA2 gene or a family history of ovarian and/or breast cancer were tested every 4 months, with an annual transvaginal ultrasound scan. This study also showed that screening identified more early stage cancers than no screening.
The ROCA Test cannot detect all ovarian cancers. Up to 15% of women with ovarian cancer may be missed by the ROCA Test and therefore it is still very important for women to remain aware of the symptoms of ovarian cancer.
- Menon U, Ryan A, Kalsi J, Gentry-Maharaj A, Dawnay A, et al. (2015) A risk algorithm using serial biomarker measurements doubles the number of screen-detected cancers compared to a single threshold rule in the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) J Clin Oncol; Jun 20;33(18):2062-71.
- http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/ovarian-cancer. Last accessed January 2016.
- Rosenthal AN, Fraser L, Philpott S, et al., Results of 4-monthly screening in the UK Familial Ovarian Cancer Screening Study (UK FOCSS Phase 2). Presented at American Society of Clinical Oncology. Chicago, IL; 2013.