Description

Assess Risk of Ovarian Cancer in Women with Ovarian Masses

The ROMA test is a clinically validated diagnostic tool that calculates the likelihood of ovarian cancer in women who present with an ovarian mass. It combines two key blood biomarkers with a patient’s menopausal status to generate a personalized risk score, helping to guide further clinical decisions.

Purpose of the ROMA Test

  • Evaluate the risk of malignancy in ovarian masses.
  • Distinguish between benign and malignant tumors.
  • Support triage and referral decisions, especially to gynecologic oncologists.
  • Assist in determining the need for additional imaging, biopsy, or surgery.

How the ROMA Test Works

Biomarkers Measured

  • HE4 (Human Epididymis Protein 4)
  • Often elevated in ovarian cancer.
  • Offers higher specificity compared to CA125.
  • CA125 (Cancer Antigen 125)
  • A commonly used ovarian cancer biomarker.
  • Can also be elevated in non-cancerous conditions like endometriosis or fibroids.

Menopausal Status

  • The algorithm adjusts interpretation based on whether the patient is pre-menopausal or post-menopausal, as hormone levels and biomarker thresholds differ between the two.

ROMA Score Calculation

  • Combines levels of HE4, CA125, and menopausal status.
  • Results yield a numerical ROMA score that stratifies cancer risk:
  • Low ROMA Score → Low risk of malignancy
  • High ROMA Score → Elevated risk of ovarian cancer; further workup may be necessary

Key Benefits

  • Higher Accuracy: More reliable than CA125 alone for detecting malignancy.
  • Non-Invasive: Simple blood draw with no special preparation needed.
  • Clinically Actionable: Helps determine the next steps in diagnosis and treatment planning.
  • Personalized Assessment: Tailored to menopausal status for better risk estimation.

Fasting Requirements

  • Not required — the test can be performed at any time of day.

Who Should Consider the ROMA Test?

  • Women with an identified ovarian mass
  • Patients needing risk stratification before surgery or further imaging
  • Providers seeking to optimize referral decisions to specialists