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HE4/ROMA & Their Role in Ovarian Cancer

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The diagnosis of ovarian cancer relies on clinical examination (abdominal and gynaecological examination) and imaging (scanner, MRI: work-up for extension). The diagnosis is confirmed by tissue sample analysis, which is carried out through laparoscopy or laparotomy. 

Diagnosis is often made late due to the clinical examination remaining normal and the symptoms, when present, being unspecific. In terms of laboratory testing, the main marker is the CA125 serum marker, however, it is low in specificity and sensitivity. The CA125 assay is not recommended for the screening of ovarian cancer. It is recommended, for the monitoring and follow-ups of patients with ovarian cancer. 

HE4 (Human Epididymal Protein) is a glycoprotein that belongs to the WFDC2 (Whey Acidic Four Disulphide Core protein) family, previously the WAP gene family, which includes protease inhibitors. Even in the first stages of ovarian cancer (stages I and II), HE4 is over-expressed and mainly found in serous, endometrial and clear-cell cancers. Its expression is independent of CA125 and it is effective in 50% of cancers that do not express CA125. 

The combination of these two serum markers offers the greatest sensitivity and specificity for the detection of ovarian cancers and their recurrence.

The ROMA (Risk of Ovarian Malignancy Algorithm) algorithm integrates the HE4 assay, the CA125 assay and the menopausal status of patients in order to evaluate the malignancy risk of a pelvic mass. HE4 and ROMA improve patient care for those suffering from ovarian cancer. This cancer has a low incidence rate but a high mortality rate.


Method: Electrochemiluminescence

To assess the malignancy risk with the ROMA algorithm, HE4 and CA125 must be measured using the same technique, which doesn’t authorise the integration of a transferred CA125 result. The menopausal status must be specified. The requesting of this test must indicate the ROMA calculation for it to be performed.

Sample requirements: 1 mL serum (minimal quantity: 600 μL). The serum must be separated from the whole blood and then frozen.

Turnaround Time: 4 working days

For further information on this test please contact Eurofins Biomnis Ireland on 1800 252 966 or email us at clientservices@eurofins.ie