Abbott Diagnostics


	Ovarian Risk Calculator
	This calculator is intended for health care professionals only and is not intended for patient use. This ROMA calculator can only be used with ARCHITECT HE4 and CA125 values. Values obtained with different assay methods can not be used interchangeably due to differences in assay methods and reagent specificity. Enter your ARCHITECT CA125 and ARCHITECT HE4 levels below to use ROMA to calculate risk of epithelial ovarian cancer. Select premenopausal or postmenopausal to determine risk. CA125 Value: Please enter a value within the approved range (1.0 to 1000 U/ml) per the ARCHITECT CA125 assay package insert. Please refer to the ARCHITECT CA125 package insert for additional information. HE4 Value: Please enter a value within the approved range (20.0 to 1500.0 pmol/L) per the ARCHITECT HE4 assay package insert. Please refer to the ARCHITECT HE4 package insert for additional information.
	PREMENOPAUSAL	POSTMENOPAUSAL
	CA125 Value:	U/ml
	HE4 Value:	pmol/L
	Risk (%):

(Risk of Ovarian Malignancy Algorithm)
Classifies patients as being low or high risk for malignant disease

Physicians will receive the individual CA125 value, HE4 value and ROMA – 1 for premenopausal patient and 1 for postmenopausal.

ROMA VALUE SPECIFIC TO ABBOTT ARCHITECT¹
Premenopausal	Postmenopausal
≥ 7.4% High risk of finding EOC	≥ 25.3% High risk of finding EOC
< 7.4% Low risk of finding EOC	< 25.3% Low risk of finding EOC

ROMA is an exciting diagnostic advance that will change the future of ovarian cancer by better stratifying patients at risk of EOC in order to identify the right patient, right physician, right outcome.

Studies with ROMA demonstrate that 87.3% of patients with Epithelial Ovarian Cancer (EOC) and Low Malignant potential tumors were correctly classifi ed as high risk. The Negative Predictive Value (NPV) in the total population studied was 93.2%.¹

Menopausal Status	Disease	Sensitivity	Specificity	PPV	NPV
Combined	Benign + Cancer Total	87.3%	75.3%	60.6%	93.2%
Premenopausal	Benign + Cancer Total	79.4%	75.4%	36.0%	95.5%
Postmenopausal	Benign + Cancer Total	89.7%	75.2%	73.8%	90.3%

ARCHITECT is a trademark of Abbott Laboratories in various jurisdictions.
1 Abbott data on file.