About ROMA™ and HE4

Clinical Data

The Use of Multiple Novel Tumor Biomarkers for the Detection of Ovarian Carcinoma in Patients with a Pelvic Mass. Gynecologic Oncology. 108(2); 402-408. (2008) Richard G. Moore et al.

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

Multiple Novel Biomarkers for the Detection of Ovarian Cancer7

In a 2007 prospective trial examining the use of multiple novel biomarkers and the creation of a multiple marker assay to detect ovarian cancer in women presenting with pelvic mass, 259 patients with adnexal masses were enrolled. Of these, 233 were eligible for analysis with 67 invasive epithelial ovarian cancers and 166 benign ovarian neoplasms.

Results

  • Mean values for all marker levels except HER-2/neu differed significantly between patients with benign masses and cancer
  • As a single marker, HE4 had the highest sensitivity at 72.9% (specificity 95%)
  • Combined, CA125™ and HE4 yielded the highest sensitivity at 76.4% (specificity 95%)
  • The combination of CA125 and HE4 added 33.1% to the sensitivity of CA125 alone and 3.5% to the sensitivity of HE4 alone
  • Additional markers added only minimally to the sensitivity of the CA125 and HE4 combination
  • HE4 was the best single marker for Stage I disease, with no increase in sensitivity when combined with CA125 or any other marker

As a single tumor marker, HE4 had the highest sensitivity for detecting ovarian cancer, especially Stage I disease. Combined, CA125 and HE4 is a more accurate predictor of malignancy than either is alone.

Other biomarkers analyzed were soluble mesothelin-related peptide (SMRP), CA72-4®, activin A, inhibin, osteopontin, epidermal growth factor receptor (EGFR), and serum HER-2/neu. All tumor marker levels were compared with the final pathologic diagnosis. The addition of osteopontin or inhibin to HE4 did increase the sensitivity of HE4 alone (to 73.1% or 74.4%, respectively), but the increase in sensitivity did not exceed that of the HE4 and CA125 combination (76.4%).

The analysis of multiple biomarker combinations (3 or more) added only a small percentage to the sensitivity of combined CA125 and HE4.

Novel Marker Assay, ROMA for malignancy assessment in women with pelvic mass8

In 2011, a prospective multicenter trial was published to validate ROMA for assessing the likelihood of epithelial ovarian cancer (EOC) in women with an adnexal mass. For this study, 472 patients were initially assessed by generalist Ob/Gyns and primary care physicians for the likelihood of malignancy and subsequently underwent surgery.

An analysis of the serum tumor markers HE4 and CA 125, along with the ROMA score was performed for all patients as well as for postmenopausal and premenopausal patients as separate groups.

Results

  • The dual marker algorithm stratified patients into low- and high-risk malignancy groups using the designated predictive probability thresholds for premenopausal and postmenopausal women.
  • The high-risk group was defined as a predictive probability of >13.1% for premenopausal women and >27.7% for postmenopausal women.
  • The study demonstrated that the Risk of Ovarian Malignancy Algorithm, or ROMA™, successfully classified patients, with 94% of EOC correctly classified as high risk.
  • The negative predictive value (NPV) in the total population studied was 99%, meaning the test achieved a false negative rate of 1% in the combined patient population.

The dual marker combination of HE4 and CA125 using ROMA can help classify women into high- and low-risk groups, allowing for the effective triage of women to appropriate surgical centers for their care.

ROMA is FDA-cleared and available for clinical use. For ordering information, please contact your laboratorian.

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