• HE4 and ROMA® Seminal Studies

     
    Since 2008, there have been over 125 peer-reviewed publications regarding the use of HE4 in ovarian cancer detection and management.

    The following studies have been selected to conveniently summarize the most formative data related to HE4 and ROMA® (Risk of Ovarian Malignancy Algorithm) used in the assessment and management of patients with a pelvic mass.
     

    HE4 Studies:

    1. Moore RG, Miller MC, Steinhoff MM, et al. Serum HE4 levels are less frequently elevated than CA125 in women with benign gynecologic disorders. Am J Obstet Gynecol. 2012;206(4).
    2. Moore RG, McMeekin DS, Brown AK, 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;112(1):40-46.
    3. Holcomb K, Vucetic Z, Miller MC, et al. Human epididymis protein 4 offers superior specificity in the differentiation of benign and malignant adnexal masses in premenopausal women. Am J Obstet Gynecol. 2011;205(4):1-6.
    4. Lycke M, Kristjansdottir B, Sundfeldt K. A multicenter clinical trial validating the performance of HE4, CA125, risk of ovarian malignancy algorithm and risk of malignancy index. Gynecol Oncol. 2018;151(1):159-165. 
    5. Lin J, Qin J, Sangvatanakul V. Human epididymis protein 4 for differential diagnosis between benign gynecologic disease and ovarian cancer: A systematic review and meta-analysis. European Journal of Obstetrics Gynecology and Reproductive Biology, 2013;167(1), 81–85.

     
    ROMA Studies:

    1. Moore RG, Hawkins DM, Miller MC, et al. Combining clinical assessment and the Risk of Ovarian Malignancy Algorithm for the prediction of ovarian cancer. Gynecologic Oncology, 2014;135(3), 547–551.
    2. Moore RG, Miller MC, Disilvestro P, et al. Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass. Obstetrics and Gynecology, 2011;118(2 Pt 1), 280–288.
    3. Dayyani F, Uhlig S, Colson B, et al. (2016). Diagnostic Performance of Risk of Ovarian Malignancy Algorithm Against CA125 and HE4 in Connection With Ovarian Cancer: A Meta-analysis. International Journal of Gynecological Cancer: Official Journal of the International Gynecological Cancer Society. 
    4. Moore RG, Blackman A, Miller MC, et al. Multiple biomarker algorithms to predict epithelial ovarian cancer in women with a pelvic mass: Can additional makers improve performance? Gynecol Oncol. 2019;154(1):150-155. 
    5. Karlsen MA, Sandhu N, Høgdall C, et al. Evaluation of HE4, CA125, risk of ovarian malignancy algorithm (ROMA) and risk of malignancy index (RMI) as diagnostic tools of epithelial ovarian cancer in patients with a pelvic mass. Gynecol Oncol. 2012;127(2):379-383.