Clinical benefit #1
Among women presenting with pelvic mass, a combined use of HE 4 and CA 125 using ROMA (Risk of Ovarian Malignancy Algorithm) can increase the sensitivity and specificity for assessing the risk of ovarian cancer - even stages I/II ovarian cancer – as compared to testing CA 125 alone
- ROMA accurately identifies 94% of the patients with pelvic mass as having ovarian cancer6
- ROMA has a higher sensitivity than CA 125 alone: Among ten women with ovarian cancer, ROMA identifies one more patient than CA 125 alone (sensitivity: ROMA 90% vs. CA 125 79%)7
- ROMA has a higher specificity than CA 125 alone: Among ten women with benign gynecologic diseases, ROMA dismisses one more patient which CA 125 alone would include as having ovarian cancer (Specificity: ROMA 93% vs. CA 125 86%)7
- ROMA has a higher sensitivity and specificity in detecting stages I/II ovarian cancer than CA 125 alone8
Clinical benefit #2
Determining HE 4 and CA125 independently can improve ovarian cancer monitoring
- Either HE 4 or CA 125 levels can be elevated in patients during therapy monitoring and recurrence monitoring9-11
- At disease progression, some patients show an elevated HE 4 level earlier than an increase in CA 125 level, and others show an elevated CA 125 level earlier than an increase in HE 4 level. Therefore, HE 4 and CA 125 together can effectively monitor therapy response9-11
- As patients with elevated CA 125 level at diagnosis can switch to elevated HE 4 level at follow up, and vice versa, testing for both HE 4 and CA 125 can identify patients with recurrent disease that CA 125 alone would miss11
Technical benefit
Efficiency and reliability for the laboratory
- Shows excellent precision across the entire measuring range for reliable results
- Uses a low sample volume (20 ul)
- Is fast with 18 minute assay time
- Is available for use in both serum and plasma
Consolidation of 17 tumor marker assays is available on one automated platform
