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Test Name

ROMA™ (Risk of Ovarian Malignancy Algorithm)

To view specimen requirements and codes please Select a regional laboratory.

Not sure which laboratory serves your office? Call us 866-MYQUEST (866-697-8378)

CPT Code(s)**

86304, 86305 or 81500*
*The 2018 AMA CPT codebook contains the component CPT codes and the new MAAA codeset. Please direct any questions regarding coding to the payor being billed.
**IMPORTANT: CPT Code is informational only; obtain the Test Code for ordering.

Includes

CA125, HE4 Ovarian CA Monitoring, and Risk of Ovarian Malignancy calculation

Methodology

Calculation (CALC) • Chemiluminescent Microparticle Immunoassay (CMIA)

Reference Range(s)

ROMA Premenopausal <1.31
ROMA Postmenopausal <2.77
CA125 <35 U/mL
HE4, Ovarian CA Monitoring  
  Female Premenopausal ≤70 pmol/L
  Female Postmenopausal ≤140 pmol/L

Clinical Significance

The risk of Ovarian Malignancy Algorithm (ROMA™) test is intended to aid in assessing the risk of ovarian cancer in women with a pelvic mass based on the patient's HE4 and CA125 levels, and their menopausal status. Women with ROMA™ levels above the cutoff have an increased risk of ovarian cancer. ROMA™ must be interpreted in conjunction with an independent clinical and radiological assessment.

The ROMA™ test is indicated for women who meet the following criteria:
over age 18; presence of an ovarian pelvic mass for which surgery is planned; and not yet referred to an oncologist.

The CA125 and HE4 tests are performed using the Abbott ARCHITECT i2000SR unit. The values obtained with different assay methods cannot be used interchangeably due to differences in assay methods and reagent specificity.

The test is not intended as a screening stand-alone diagnostic or tumor monitoring assay. Tumor monitoring using HE4 and/or CA125 should be ordered separately.

The ROMA value is the result of a computation based on the HE4 and CA125 values observed.
Reference:
1. Moore RG, et al. A novel multiple marker bioassay utilizing HE4 and CA 125 for the prediction of ovarian cancer in patients with a pelvic mass. Gynecol Oncol 2009; 112:40-6.

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

* The tests listed by specialist are a select group of tests offered. For a complete list of Quest Diagnostics tests, please refer to our Directory of Services.

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ROMA™ (Risk of Ovarian Malignancy Algorithm)
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