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ROMA Calculation Tool Using Elecsys Assays (RCTUEA) is a qualitative test for serum and plasma (K2-EDTA, K3-EDTA and Li-Heparin) that combines the results of the Elecsys HE4 assay, Elecsys CA 125 II assay and menopausal status into a numerical score. RCTUEA is intended to aid in assessing whether a premenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. RCTUEA is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. RCTUEA must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening or stand-alone diagnostic assay. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. PRECAUTION: RCTUEA should not be used without an independent clinical/ radiological evaluation and is NOT intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of RCTUEA carries the risk of unnecessary testing, surgery and/or delayed diagnosis.

ROMA Calculation Tool Using Elecsys Assays (RCTUEA) is a qualitative test for serum and plasma (K2-EDTA, K3-EDTA and Li-Heparin) that combines the results of the Elecsys HE4 assay, Elecsys CA 125 II assay and menopausal status into a numerical score. ROMA was developed using separate logistic regression equations for premenopausal and postmenopausal women: Pre menopausal: Predictive Index (PI) = - 12.0 + 2.38 x LN[HE4] + 0.0626 x LN[CA 125] Post menopausal: Predictive Index (PI) = - 8.09 + 1.04 x LN[HE4] + 0.732 x LN[CA 125] RCTUEA value = exp (PI) / [1 + exp(PI)b)] x 10 RCTUEA is used to stratify women into likelihood groups for finding cancer on surgery. In order to provide a specificity level of 75 %, a cutoff point of ≥ 1.14 was used for premenopausal women and ≥ 2.99 was used for postmenopausal women who present with an ovarian adnexal mass. Women with RCTUEA results above these cutoff points are at high likelihood of finding malignancy on surgery. The immunoassays used in RCTUEA are: Elecsys HE4: an electrochemiluminescence immunoassay for the quantitative determination of HE4 in human serum and plasma Elecsys CA 125 II: an electrochemiluminescence immunoassay for the quantitative determination of OC 125 reactive determinants in human serum and plasma.

Lumipulse® G Risk of Ovarian Malignancy Algorithm (ROMA®) is a qualitative serum and plasma (lithium heparin or dipotassium EDTA) test that combines the results of Lumipulse G CA 1251 and menopausal status into a numerical score. Lumipulse G ROMA is intended to aid in assessing whether a premenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. Lumipulse G ROMA is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. Lumipulse G ROMA must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening or stand-alone diagnostic assay. PRECAUTION: Lumipulse G ROMA should not be used without an independent clinical /radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of Lumipulse G ROMA carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

Lumipulse GROMA is a qualitative serum and plasma test that combines the results of 2 analytes, HE4 (Lumipulse G HE4) and CA125 (Lumipulse G CA 125 II) and menopausal status into a numerical score between 0.00 and 10.00. The premenopausal status must be based on ovarian function determined with information available from clinical evaluation and medical history. The test system consists of Lumipulse G HE4, Lumipulse G CA 125 II, the Lumipulse G ROMA Calculator Tool and the LUMIPULSE G1200 System. The LUMIPULSE G1200 System is not capable of calculating the ROMA score. The immunoassays are performed according to the directions detailed in each product insert. Both Lumipulse G HE4 and Lumipulse G CA 125 Il are previously 510(k) cleared Class II devices (k151378 and k142895 respectively). The Lumipulse G HE4 assay is a chemiluminescent enzyme immunoassay (CLEIA) for the quantitative determination of HE4 antigen in human serum and plasma (lithium heparin or dipotassium EDTA) on the LUMIPULSE G System. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. Lumipulse G CA 125 II assay is a chemiluminescent enzyme immunoassay (CLEIA) for the quantitative determination of CA125 in human serum and plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMPULSE G System. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with ovarian cancer. Serial testing for patient CA125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. Lumipulse G ROMA scores (numerical score from 0.00 -10.00) for both premenopausal and postmenopausal women are calculated using the Lumipulse G ROMA Calculator Tool to indicate a low likelihood or high likelihood for finding malignancy on surgery using the value of the 2 immunoassays (Lumipulse G HE4 and Lumipulse G CA125II).

ARCHITECT Risk of Ovarian Malignancy Algorithm (ROMA) is a qualitative serum test that combines the results of ARCHITECT HE4. ARCHITECT CA 125 II and menopausal status into a numerical score. ARCHITECT ROMA is intended to aid in assessing whether a premenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. ARCHITECT ROMA is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. ARCHITECT ROMA must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening or stand-alone diagnostic assay. PRECAUTION: ARCHITECT ROMA should not be used without an independent clinical fradiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of ARCHITECT ROMA carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

ARCHITECT ROMA is a qualitative serum test that combines the results of 2 analytes, HE4 (ARCHITECT HE4) and CA125 (ARCHITECT CA 125 II) and menopausal status into a numerical score between 0.0 and 10.0. The premenopausal status must be based on ovarian function determined with information available from clinical evaluation and medical history. The test system consists of the ARCHITECT HE4 assay, the ARCHITECT CA 125 Il assay and the ARCHITECT i2000SR. The ARCHITECT i2000SR is capable of calculating the ROMA score. The immunoassays are performed according to the directions detailed in each product insert.

The OVA1 Next Generation test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Next Generation test is an aid to further assess the likelihood that malignancy is present when the physician's independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay.

The OVA1 Next Generation (NG) test consists of software, instruments, assays and reagents. The software incorporates the results of serum biomarker concentrations from five immunoassays to calculate a single, unitless numeric result indicating a low or high risk of ovarian malignancy. The assays used to generate the numeric result (OVA1 NG test result) are APO, CA 125 II, FSH, HE4 and TRF. Biomarker values are determined using assays on the Roche cobas® 6000 system, which is a fully automated, software-controlled system for clinical chemistry and immunoassay analysis. The biomarker assays are run according to the manufacturer's instructions as detailed in the package insert for each reagent. The OVA1 NG software (OvaCalc v4.0.0) contains a proprietary algorithm that utilizes the results (values) from the five biomarker assays, (APO, CA 125 II, FSH, HE4 and TRF). The assay values from the cobas 6000 system are either imported into OvaCalc through a .csv file or manually entered into the OvaCalc user interface to generate an OVA1 NG test result between 0.0 and 10.0. A low- or high-risk result is then determined by comparing the software-generated risk score to a single cutoff (low-risk result <5. high-risk result ≥5).

For In Vitro Diagnostic Use Only. The Risk of Ovarian Malignancy Algorithm (ROMA™) is a qualitative serum test that combines the results of HE4 EIA, ARCHITECT CA 125 II™ and menopausal status into a numerical score. ROMA is intended to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. ROMA is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. ROMA must be interpreted in conjunction with an independent clinical and radiological assessment. The test is not intended as a screening or stand-alone diagnostic assay. PRECAUTION: ROMA (HE4 EIA + ARCHITECT CA 125 II) should not be used without an independent clinical fradiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of ROMA (HE4 EIA + ARCHITECT CA 125 II) carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

The Risk of Ovarian Malignancy Algorithm (ROMATM) is a qualitative serum test in the form of a mathematical function combining the results of HE4 EIA, ARCHITECT CA 125 II™ and menopausal status into a numerical score. ROMA was developed in a training set using separate logistic regression equations for premenopausal and postmenopausal women: Premenopausal woman: Predictive Index (PI) = -12.0 + 2.38*LN[HE4] + 0.0626*LN[CA 125] Postmenopausal woman: Predictive Index (PI) = -8.09 + 1.04*LNIHE4] + 0.732*LNJCA 125J ROMA = exp(PI) / [1 + exp(PI)] *10 ROMA is used to stratify women into likelihood groups for finding cancer on surgery. In order to provide a specificity level of 75%, a cut point of ≥ 1.31 was used for premenopausal women and ≥ 2.77 was used for postmenopausal women who present with an ovarian adnexal mass. Women with ROMA results above these cut points is at high likelihood of finding malignancy on surgery. The test system consists of the assays, reagents, software and instrument used to obtain the ROMA result. The ROMA instructions for use are provided with the HE4 EIA Kit. The HE4 EIA and ARCHITECT CA 125 II are performed according to the manufacturers' directions detailed in each product insert. The immunoassays used in ROMA are: HE4 EIA: The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum. ARCHITECT CA 125 II: The ARCHITECT CA 125 II assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of OC 125 defined antigen in human serum and plasma on the ARCHITECT i System.

The OVA1™ Test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18; ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA 1 Test is an aid to further assess the likelihood that malignancy is present when the physician's independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. PRECAUTION: The OVA1™ Test should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1™ Test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

The OVA1™ Test uses OvaCalc Software to incorporate the values for 5 analytes from separately run immunoassays (described below) into a single numerical score between 0.0 and 10.0. The cleared test system consists of the software, instruments, assays and reagents used to obtain the OVA1™ Test result. The immunoassays and reagents are sold separately from the OvaCalc Software. Users are instructed to use only those lots identified by Vermillion. The immunoassays are performed according to the manufacturers' directions detailed in each product insert. The analytes and corresponding tests and calibrators used in the OVA1™ Test are: | Analyte | Device (Assay and Calibrator) | Instrument | |-----------------------|-----------------------------------------------------------------------------------------------------------|--------------------| | CA 125 | Elecsys CA 125 II<br>CA125 II CalSet | Roche Elecsys 2010 | | Prealbumin | N Antisera to Human Prealbumin and<br>Retinal-binding Protein<br>N Protein Standard SL (human) | Siemens BN II | | Apolipoprotein<br>A-1 | N-Antisera to Human Apolipoprotein A-1<br>and Apolipoprotein B<br>N Apolipoprotein Standard Serum (human) | Siemens BN II | | β2-microglobulin | Human Beta-2 Microglobulin Latex<br>Enhanced Nephelometric Kit (Binding Site) | Siemens BN II | | Transferrin | N Antisera to Human Transferrin and<br>Haptoglobin<br>N Protein Standard SL (human) | Siemens BN II | The user enters results of the five analytes manually into an Excel spreadsheet together with the headers needed by OvaCalc Software. There is no physical or electronic connection between the immunoassay devices and the OvaCalc Software. Using an algorithm and the values of these 5 analytes, the OvaCalc Software generates a single unit-less numerical score from 0.0 to 10.0.