Limitations

The ROCA Test does not detect all women with ovarian cancer. Therefore, it is very important for women to remain aware of the symptoms and speak with their doctor if they are concerned.

The ROCA Test is NOT to be used as the only test to determine whether you should proceed to surgery or undergo other treatment for ovarian cancer. An abnormal ROCA Test should always be followed by a transvaginal ultrasound examination. In some circumstances, other tests (e.g. pelvic exam, MRI, CT Scan) may be conducted to help the doctor determine whether surgery is necessary.

An abnormal (“Intermediate” or “Elevated”) ROCA Test result does not mean you definitely have ovarian cancer. Your ROCA score could be abnormal due to other reasons such as: colitis, chronic active hepatitis, endometriosis, rheumatoid arthritis, or osteoarthritis. Some women might have a naturally high level of a protein called CA-125 which causes a temporary high ROCA result until the test learns what your baseline is.

The current clinical recommendation for women who are considered ‘high risk’ for ovarian cancer (due to mutations in BRCA genes) is prophylactic risk-reducing surgery, typically removal of the ovaries and fallopian tubes. The ROCA Test should NOT be offered as an alternative to risk reducing surgery. Only if a woman cannot undergo or declines risk reducing surgery should the ROCA Test be considered.

Although there is evidence that more early stage ovarian cancers can be detected in women who undergo surveillance using the ROCA Test, many women will still be diagnosed after the cancer has spread.

There is no evidence to show that surveillance of women with BRCA mutations with the ROCA Test can save lives.

Surveillance for ovarian cancer using the ROCA Test may create anxiety in some women if there are abnormal results even when no cancer is present. In some women, these results will lead to surgery even when no cancer is present and occasionally the surgery will have complications. All women undergoing surveillance should understand these risks.

The ROCA Test has not been evaluated in:

Women previously treated for an ovarian cancer.

Women with symptoms that may be suggestive of ovarian cancer

Women who have had both their fallopian tubes and ovaries removed.

Women currently being treated with chemotherapy for any cancer in the last 12 months.

Women over 84 years of age.

Women with under 35 years of age.

Pregnant women.

Only a doctor can determine if the ROCA Test is appropriate for a woman.