Healthcare Professionals

Clinical Studies

Numerous clinical studies have demonstrated the utility of ROMA to determine the likelihood for Epithelial Ovarian Cancer (EOC) in women with a pelvic mass – and the benefit of using CA125 in combination with HE4 in the risk of ovarian malignancy algorithm (ROMA) to stratify patients by risk and ensure their triage to appropriate centers of care.

Here you can find a list of selected clinical studies:

Moore RG, et al. Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass.Obstet Gynecol. 2011 Aug;118(2 Pt 1):280-8.
PubMed

Molina R, et al. HE4 a novel tumour marker for ovarian cancer: comparison with CA 125 and ROMA algorithm in patients with gynaecological diseases.Tumour Biol. 2011 Dec;32(6):1087-95.
PubMed

Lenhard M, et al. The diagnostic accuracy of two human epididymis protein 4 (HE4) testing systems in combination with CA125 in the differential diagnosis of ovarian masses. Clin Chem Lab Med. 2011 Sep 16. [Epub ahead of print]
PubMed

Ruggeri G, et al.HE4 and epithelial ovarian cancer: comparison and clinical evaluation of two immunoassays and a combination algorithm. Clin Chim Acta. 2011 Jul 15;412(15-16):1447-53.
PubMed

Partheen K, et al.Evaluation of ovarian cancer biomarkers HE4 and CA-125 in women presenting with a suspicious cystic ovarian mass. J Gynecol Oncol. 2011 Dec;22(4):244-52.
PubMed

Kadija S, et al.The Utility of Human Epididymal Protein 4, Cancer Antigen 125, and Risk for Malignancy Algorithm in Ovarian Cancer and Endometriosis.Int J Gynecol Cancer. 2011 Dec 30. [Epub ahead of print]
PubMed

Bandiera E, et al. Serum human epididymis protein 4 and risk for ovarian malignancy algorithm as new diagnostic and prognostic tools for epithelial ovarian cancer management.Cancer Epidemiol Biomarkers Prev. 2011 Dec;20(12):2496-506.
PubMed

Jacob F, et al. No benefit from combining HE4 and CA125 as ovarian tumor markers in a clinical setting. Gynecol Oncol. 2011 Jun 1;121(3):487-91.
PubMed

Kim YM, et al.Evaluation of the accuracy of serum human epididymis protein 4 in combination with CA125 for detecting ovarian cancer: a prospective case-control study in a Korean population.Clin Chem Lab Med. 2011 Mar;49(3):527-34.
PubMed

Van Gorp T, et al. HE4 and CA125 as a diagnostic test in ovarian cancer: prospective validation of the Risk of Ovarian Malignancy Algorithm.Br J Cancer. 2011 Mar 1;104(5):863-70.
PubMed

Montagnana M, et al. The ROMA (Risk of Ovarian Malignancy Algorithm) for estimating the risk of epithelial ovarian cancer in women presenting with pelvic mass: is it really useful? Clin Chem Lab Med. 2011 Mar;49(3):521-5.
PubMed

Moore RG, et al. Comparison of a novel multiple marker assay vs the Risk of Malignancy Index for the prediction of epithelial ovarian cancer in patients with a pelvic mass. Am J Obstet Gynecol. 2010 Sep;203(3):228.e1-6.
PubMed

Moore RG, et al. A novel multiple marker bioassay utilizing HE4 and CA125 for the prediction of ovarian cancer in patients with a pelvic mass.Gynecol Oncol. 2009 Jan;112(1):40-6.
PubMed