- The ROCA Test is a simple blood test that determines the likelihood of a woman having ovarian cancer. The test uses a woman’s age, menopausal status, risk status and serial blood measurements of CA-125 over time to produce a score that indicates her likelihood of having ovarian cancer.
- It is the only ovarian cancer test that has been evaluated in major clinical trials and shown to be significantly more sensitive and specific than alternative methods. In clinical studies of postmenopausal women, screening using the ROCA test doubled the number of screen-detected ovarian cancers compared with the those that would have been detected using the standard CA-125 test using a fixed cut-off of 35U/ml. 1
- The ROCA Test is for postmenopausal women aged between 50 and 84, or for women between 35 and 84 years of age who have an estimated ≥10% lifetime risk of ovarian cancer.
The ROCA Test differs from a standard CA-125 in that is does not use a fixed cut-off level of 35U/ml but instead uses an algorithm-based method to assess the significance of any change in the baseline level of CA125 to predict the risk of having ovarian cancer. The algorithm compares a woman’s serial CA-125 profile to a proprietary database of known CA-125 profiles (with and without cancer). The more a woman’s profile correlates with known profiles of ovarian cancer, the greater her risk. The algorithm also uses age, menopausal status and whether a woman is high risk for ovarian cancer as factors.
The ROCA Test is intended for asymptomatic women to determine their risk of having ovarian cancer. It is not to be used when a mass is present. OVA1 and ROMA are tests intended to be used when a pelvic mass has already been detected to determine if the mass is likely to be benign or malignant.
The ROCA Test reports a numerical score that represents a woman’s risk of having ovarian cancer (e.g. 1 in 5,000). The risk score is categorised as Normal, Intermediate or Elevated and clinical recommendations as guidance for clinical follow up. The recommended clinical follow up is as defined by the UKCTOCS and UKFOCSS trials.
The ROCA Test is a first line test and should not be used to refer a patient directly to surgery. The test results will either refer a patient to a repeat ROCA Test, or a transvaginal ultrasound scan of the ovaries, the results of which are interpreted by expert clinical assessment.
- 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; Epub ahead of print 10.1200/JCO.2014.59.4945.