HE4 Risk Stratification Tool

ROMA (Risk of Ovarian Malignancy Algorithm) to
Calculate Risk of Epithelial Ovarian Cancer

The path to more optimal patient outcomes begins with the new CA125 + HE4 risk stratification tool. A new differential diagnostic for women presenting with pelvic mass to help determine the most appropriate course of care.

Enter your CA125 and HE4** levels below to use ROMA to calculate risk of epithelial ovarian cancer. Select premenopausal or postmenopausal to determine risk.

Calculate

ROMA classifies patients as being at low or high risk for malignant disease19,20

  • ROMA calculates a risk of finding ovarian cancer during surgery
    • Classifies patients as being at low or high risk for malignant disease
    • Cut points were determined by setting specificity at 75%*
  • Premenopausal group: 76% of all epithelial ovarian cancers and low malignant potential tumors are stratified as high risk and 75% of all benign cases are stratified as low risk
  • Postmenopausal group: 92% of all epithelial cancers and low malignant potential tumors as high risk and 75% of all benign cases as low risk
  • Combined patient groups: 89% of all epithelial ovarian cancers and low malignant potential tumors as high risk and 75% of all benign cases as low risk

Warning: Please read the HE4 EIA Instructions for Use for complete instructions on how to use ROMA to calculate risk. This scale presents an approximation of risk only. Consult the HE4 EIA Instructions for Use to calculate the precise risk result.

*Please read the HE4 EIA instructions for use for cut-points between low and high risk and for details on how precise risk is calculated, or contact info@fdab.com to receive this information.
**This product not available in the U.S.