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The ROMA test employed the results from tests of CA125 and HE4 within the same study.
Both high level of heterogeneity in sensitivity and specificity were found for ROMA test.
However, this assay was not significantly better than the ROMA test, which currently remains the best method for diagnosing and monitoring ovarian cancer [ 66].
In September 2011, the FDA approved the combination of the HE4 test with the MUC16 test in the Risk of Ovarian Malignancy Algorithm (ROMA) test, to determine the likelihood of finding malignancy at surgery in premenopausal or postmenopausal women presenting with an ovarian adnexal mass [ 65, 66].
A study involving 349 female patients with pelvic masses and with different menopausal status confirmed that the ROMA test outperforms the individual biomarkers in their ability to detect both early and late stage ovarian cancers, and this reached statistical significance in postmenopausal women [ 67].
The combination of HE4 and CA125, when used in the Risk of Ovarian Malignancy Algorithm (ROMA) test, is effective at classifying women presenting with a pelvic mass into high- or low-risk categories, which enables the triage of women likely to have ovarian cancer to clinical settings and surgeons with appropriate expertise [ 7, 8].
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The ROMA tests were considered as high Concern Regarding Applicability when either HE4 or CA125 test was evaluated as high Concern Regarding Applicability.
Within 9 [ 13, 14, 16- 18, 34- 37] of 11 studies, the results interpretation of index tests (HE4/CA125) were blind with reference standard test (ROMA).
The Risk of Ovarian Malignancy Algorithm (ROMA) has been tested in several clinical trials [ 15, 16].
Not until the 69th minute was Roma goalkeeper Wojciech Szczesny seriously tested, blocking Patrice Evra's firmly struck shot at the near post.
Roma Rights, Roma Wrongs.
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