Historically, physicians have utilized the CA-125 as a blood test to evaluate the likelihood of ovarian cancer in patients. The CA-125 test is not completely accurate as many noncancerous conditions can also result in increased levels of the protein. As a result, up to 50% of early stage cancers are not detected by CA-125. There are new tests that have been developed to be better than CA-125 alone at detecting all types of ovarian cancer.
The Society of Gynecologic Oncology (SGO) put out a statement in May 2013 that states “Blood levels of five proteins in women with a known ovarian mass have been reported to change when ovarian cancer is present. Tests measuring these proteins may be useful in identifying women who should be referred to a gynecologic oncologist. Recent data have suggested that such tests, along with physician clinical assessment, may improve detection rates of malignancies among women with pelvic masses planning surgery.”
OVA1® is an FDA-cleared blood test used to help evaluate the risk of ovarian cancer in patients with an adnexal mass (or pelvic mass) and planned for surgery. Using a powerful mathematical formula, the test generates an OVA1® score by combining the levels of five ovarian cancer biomarkers (including CA-125).
OVA1® has been FDA cleared for women who meet the following criteria: Are over 18 years of age, have an ovarian mass, have surgery planned, have not yet been referred to a gynecologic oncologist, have not had cancer in the past five years; and have a rheumatoid factor concentration <250 IU/mL. OVA1® should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery.
OVA1® is designed to be highly sensitive, meaning that it rarely misses a cancer. OVA1® has a sensitivity of ~96% across all ovarian cancer subtypes to ensure cancers are not missed. You can read more about OVA1® and how to qualify for the test here.
The Risk of Ovarian Malignancy Algorithm (ROMA™) is a qualitative serum test that combines the results of HE4, CA125-II and menopausal status into a numerical score to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding cancer on surgery.
ROMA is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. ROMA must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening or stand-alone diagnostic assay.
ROMA performed well for advanced ovarian cancer and high-grade serous histology by capturing 93% and 94% of these subtypes, respectively. However, a high false negative rate was observed for early stage cancers, pre-menopausal patients and other histological subtypes. You can read more about the ROMA test here.
By utilizing the tools that are currently available, such as CA 125, OVA1, ROMA, ultrasounds, and multi-biomarker analytics, physicians can more easily sort pelvic masses and get patients the care they need to improve overall outcomes and survivorship.
If ovarian cancer is suspected, it is crucial to see a gynecologic oncologist who specializes in women’s cancers.