HE4 Biomarker Test Is Approved for Use in Risk of Ovarian Malignancy Algorithm (ROMA)

In September 2011, the US Food and Drug Administration (FDA) approved marketing of the HE4 Test (Fujirebio Diagnostics, Malvern, Pennsylvania) along with the CA-125 test in the Risk of Ovarian Malignancy Algorithm, called ROMA, to determine the likelihood of finding malignancy at surgery in premenopausal or postmenopausal women presenting with an ovarian adnexal mass. Levels of the protein HE4, while not elevated in benign gynecologic conditions, have been shown to be elevated in epithelial ovarian cancers (EOC), the most common type of ovarian cancer.

ROMA is a qualitative serum test that derives a numerical score from the results of CA-125 (the most widely accepted biomarker for ovarian cancer) and HE4 blood tests, plus menopausal status, to identify patients presenting with an adnexal mass as being at high or low likelihood for having malignancy.

ROMA is indicated for women over 18 years of age with an ovarian pelvic mass for which surgery is planned but who have not yet been referred to an oncologist. Results must be interpreted in conjunction with an independent clinical and radiological assessment.

Data from a 472-patient study presented at the annual meeting of the Society of Gynecologic Oncologists[1] showed that ROMA used alone was highly accurate in assigning a combined pre- and postmenopausal patient population to ovarian cancer risk groups: 93.8% of EOCs were correctly classified as high likelihood. In postmenopausal women, the sensitivity of ROMA was 92.3%, its specificity was 76.0%, and its negative predictive value (NPV) was 97.4%. In premenopausal women, ROMA had a sensitivity of 100%, a specificity of 74.2%, and an NPV of 100%.

Data from a study of 462 patients reviewed by the FDA and published in the instructions for use of ROMA,[2] showed that, when combined with standard methods used by physicians to assess likelihood of ovarian cancer in a combined population of pre- and postmenopausal women, ROMA had a sensitivity of 88.4%, a specificity of 67.2%, and an NPV of 96.2%.

Use of the ROMA algorithm is anticipated to facilitate primary care physician identification of patients with a high likelihood of malignancy who should be referred to, and surgically managed by, a gynecologic oncologist.

References:

References

1. Moore RG, Miller C, DiSilvestro P, et al: Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass. Obstet Gynecol 118(2):280–288, 2011.

2. ROMA™ (HE4 EIA + ARCHITECT CA 125 IITM) prescribing information. Fujirebio Diagnostics, Inc., 2011.