ROMA index

The ROMA index ( Risk of Ovarian Malignancy Algorithm) is a calculation using two blood tumour markers, HE4 and CA 125, plus menopausal status to estimate the likelihood that an already identified ovarian or pelvic mass is malignant. It helps a gynaecologist decide next steps, for example whether surgery should be planned at a gynaecological oncology centre. It is not an ovarian cancer detection test for healthy women.

Who is this test for

• adult women with an ovarian or pelvic cyst or mass found on ultrasound or other imaging;
• women with such a mass before and after menopause, because the calculation also accounts for menopause;
• when a gynaecologist is assessing whether a mass is more likely benign or malignant;
• when a gynaecologist plans treatment and decides whether surgery should be arranged at a gynaecological oncology centre.

The ROMA index is not intended for:

• screening healthy women without a pelvic mass;
• pregnant women or girls under 18;
• women receiving chemotherapy or treated for malignant disease;
• monitoring already treated ovarian cancer, for which CA 125 is usually used.

Croatia has no national early ovarian cancer detection programme. If bloating, abdominal or pelvic pain, or feeling full early persists for several weeks, contact a gynaecologist. Read more in the article Early signs of ovarian cancer.

What the ROMA index is and what it shows

CA 125 rises in most advanced ovarian cancers but also in many benign conditions, such as endometriosis, fibroids, pelvic inflammation or menstruation. HE4 (human epididymal protein 4) is a marker that rises less often in benign gynaecological conditions, particularly endometriosis. When both are measured from the same blood sample, a formula accounting for whether a woman is before or after menopause produces one number: the ROMA value.

This value classifies the mass as low or high risk for malignancy. The combination provides a more reliable assessment than either marker alone but does not establish a diagnosis. Whether a mass is benign or malignant is ultimately shown by tissue analysis after surgery. The ROMA index is always interpreted alongside examination and ultrasound findings.

Preparation and sample

A venous blood sample is taken, and fasting is not required. If you menstruate, it is better to sample after it ends unless your gynaecologist advises otherwise, because menstruation can raise CA 125.

Menopausal status matters for the calculation, so at blood collection state when your last period occurred and whether your ovaries or uterus have been removed. Also mention kidney disease or smoking because these can affect the result. If you take biotin (e.g. hair and nail supplements), mention this at blood collection.

How results are interpreted

The report shows HE4 and CA 125 values, the calculated ROMA value and a low- or high-risk designation. Cut-offs depend on the test manufacturer and whether you are before or after menopause; those printed on the report apply. Results are interpreted alongside examination, ultrasound and symptoms.

• Low risk means a malignant mass is less likely but does not exclude it. The gynaecologist decides on follow-up or surgery according to the overall findings.
• High risk means a malignant mass is more likely, not that cancer is confirmed. Further investigations and surgery planning at a centre treating ovarian tumours usually follow.

Conditions raising an individual marker may complicate results. CA 125 is often high in endometriosis, fibroids, pelvic inflammation, liver cirrhosis or abdominal fluid. HE4 is higher with impaired kidney function, in smokers and older people. One result is therefore never sufficient for a decision.

How to arrange testing

You can come for blood collection without an appointment or referral at one of our branches throughout Croatia (listed on the Contactpage). Prices for all tests and panels are listed in the service price list. HE4 and CA 125 for the ROMA index are measured from the same blood sample.

Frequently asked questions

Can the ROMA index detect ovarian cancer?

Not as a stand-alone test. The ROMA index estimates the likelihood that an already identified mass is malignant and helps a gynaecologist plan. It is not used for early cancer detection in women without a mass or symptoms.

What does a high ROMA index mean?

It means a mass is more likely to be malignant and further investigation is needed. Some women with a high index have a benign mass, particularly with endometriosis or kidney disease. Only tissue analysis provides the answer.

Is CA 125 alone or the ROMA index better?

When assessing an ovarian mass, the ROMA index provides more information because it includes CA 125 together with HE4 and menopause. CA 125 is usually used to monitor treated ovarian cancer; an oncologist decides on additional markers. Your gynaecologist will recommend which test to have.

Should the ROMA index be tested preventively?

No. In women without a pelvic mass, the result has no clear meaning and may cause unnecessary worry. Regular gynaecological examinations and contacting a doctor when symptoms persist are important for prevention.