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Ovarian Cancer

It's more than a test. 

IT'S STRATIFYING THE RISK OF OVARIAN MALIGNANCY.

 

For in vitro diagnostic use.

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The Global impact of Ovarian Cancer

There were >313,000 ovarian cancer cases diagnosed globally in 20201

It is the third most common gynecological cancer following cervical and uterine1,2 

It is more common in post-menopausal women, with rising incidence associated with increasing age.2

When ovarian cancer is diagnosed at the earliest stage, the average 5-year survival prognosis is 93%.3 However, the disease can be difficult to detect due to a lack of routine screening, non-specific symptoms and low specificity of imaging methods.2, 4–7

These diagnostic challenges mean that 80% of cases are detected at advanced stages with a 70–95% risk of disease recurrence;8,9 hence why post-treatment surveillance is recommended for the first five years after diagnosis.

 

 

INCORPORATING BIOMARKERS CA 125, HE4 AND AN ALGORITHM TO EVALUATE PATIENTS WITH AN ADNEXAL MASS

Determining the likelihood of malignancy in patients presenting with an adnexal mass is critical as appropriate referral to a gynecological oncologist is associated with improved overall survival rates. Detecting epithelial ovarian cancer earlier could potentially reduce the mortality rate by 15 - 30%.5

1. Routine Assessment

Patient presenting with an adnexal mass confirmed via routine assessment.
 

2. Clincal Assessment

Clinical information is evaluated through symptom assessment, medical history, imaging scans and pelvic exams.
 

3. Biomarker Assessment

In conjunction with other clinical and diagnostic findings, the combination of HE4 and CA 125, can be used to provide a more accurate assessment for the risk of malignancy than either marker alone.10–13
 

4. Referral

High-risk patients can be referred to a GYN/ONC for surgical consultation and monitoring.
 

5. Referral

Low-risk patients can be referred to an OB/GYN for surgical consultation and monitoring.

*ROMA = Risk of Malignancy Algorithm

UTLIZING BIOMARKER TESTING TO IMPROVE OVARIAN CANCER MANAGEMENT

INFORMED DECISIONS FOR
EVERY PATIENT

For many women facing ovarian cancer, we can help clinicians make more informed decisions for their patients on risk stratification, monitoring and recurrence of progressive disease.

THE ROLE OF SERUM BIOMAKERS AND ALGORITHMS IN OVARIAN CANCER RISK STRATIFCATION

Watch our webinar with an OB-GYN, a gynecologic oncologist and a minimally invasive gynecologic surgeon to learn more about the use of CA 125, HE4 and ROMA in the risk stratification for ovarian cancer.

Abbott's CA 125 II and HE4 BIOMARKER ASSAYS AND ROMA CAN HELP WITH:

Risk stratification in patients presenting with adnexal mass

CA 125 II is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer.10

Tracking treatment
response
 

HE4 is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer.11

Supporting the monitoring of disease progression or recurrence

ROMA is used to aid in the assessment of risk of epithelial ovarian cancer in patients presenting with an adnexal mass who will undergo surgical intervention.12

The results must be interpreted in conjunction with other methods in accordance with standard clinical management guidelines.10-12

Click here for the full Intended Use and Important Safety information for CA 125 II, HE4, and ROMA assays.

Related publications

Authors summarize ovarian biomarkers and their clinical performance and value for risk stratification, monitoring, and recurrence of ovarian cancer.

 

PublicationDescription
Evaluation of the Diagnostic Accuracy of the Risk of Ovarian Malignancy Algorithm in Women With a Pelvic Mass
This study validated the Risk of Malignancy Algorithm (ROMA), combining serum markers HE4 and CA125, along with menopausal status, to effectively stratify women with pelvic masses into high and low-risk groups for ovarian cancer, supporting its use in triaging patients to gynecologic oncologists.
Cost-analysis comparison of clinical risk assessment with and without ROMA for the management of women with pelvic masses
This study compares the cost-effectiveness of using the ROMA score versus initial clinical risk assessment (ICRA). Overall, the study suggests utilizing the ROMA score improves the detection of malignancy and reduces healthcare costs in women with pelvic masses.

Learn more about the biomarker utilization in the risk assessment and disease management of epithelial ovarian cancer.

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INTENDED USE AND IMPORTANT SAFETY INFORMATION

Instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions.

CAUTION: The Alinity i CA 125 II assay and Alinity i HE4 assay require the handling of human specimens. It is recommended that all human sourced materials be considered potentially infectious and handled in accordance with the OSHA Standard on Bloodborne Pathogens. Biosafety Level 2 or other appropriate biosafety practices should be used for materials that contain or are suspected of containing infectious agents. The Alinity i CA 125 II assay contains sodium azide. Contact with acids liberates very toxic gas. Dispose of contents/container in accordance with local regulations. United States

Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to by or on the order of a physician.

ALINITY I CA 125 II ASSAY10

WARNING: The concentration of CA 125 in a given specimen, determined with assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the CA 125 assay used. Values obtained with different assay methods cannot be used interchangeably. If, in the course of monitoring a patient, the assay method used for determining CA 125 levels serially is changed, additional sequential testing should be carried out. Before changing assays, the laboratory MUST confirm baseline values for patients being serially monitored.

INTENDED USE: The Alinity i CA 125 II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of OC 125 defined antigen in human serum and plasma on the Alinity i analyzer.

The Alinity i CA 125 II assay is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 II assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

ALINITY I HE4 ASSAY11

WARNING: HE4 assay values obtained with different assay methods cannot be used interchangeably due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the HE4 assay used. If, in the course of monitoring a patient, the assay method used for determining serial HE4 levels is changed, additional sequential testing should be carried out. Prior to changing assays, the laboratory MUST confirm baseline values for patients being serially monitored. The Alinity i HE4 assay should not be used as a cancer screening test.

INTENDED USE: The Alinity i HE4 assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of HE4 antigen in human serum on the Alinity i analyzer.

The Alinity i HE4 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.

Alinity I ROMA12

PRECAUTION: Alinity i 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 Alinity i ROMA carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

INTENDED USE: Alinity i Risk of Ovarian Malignancy Algorithm (ROMA) is a qualitative serum test that combines the results of Alinity i HE4, Alinity i CA 125 II, and menopausal status into a numerical score.

Alinity i 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. Alinity i 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. Alinity i ROMA must be interpreted in conjunction with an independent clinical and radiological assessment. This test is not intended as a screening or standalone diagnostic assay.

 

 

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References
  1. Sung H, et al., 2021. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries CA Cancer J Clin.7:209_249. doi: 10.3322/caac.21660.
  2. Momenimovahed Z, Tiznobaik A, Taheri S, et al., 2019. Ovarian cancer in the world: epidemiology and risk factors. Int J Womens Health. 11:287–299. doi:10.2147/IJWH.S197604.
  3. Ovarian Cancer Research Alliance. Ovarian cancer stages, survival rate and prognosis, OCRA. Available at: https://ocrahope.org/get-thefactsstaging#:~:text=Based%20on%20this%20information%2C%20
    doctors,means%20the%20cancer%20has%20spread. Last accessed: 31 July 2023.
  4. Chan JK, Tian C, Kesterson JP, et al., 2022. Symptoms of women with high-risk early-stage ovarian cancer. Obstet Gynecol. 10.1097/AOG.0000000000004642.
  5. Yang WL, Lu Z, Bast RC Jr. The role of biomarkers in the management of epithelial ovarian cancer. Expert Rev Mol Diagn. 2017;17(6):577–591. doi:10.1080/147 37159.2017.1326820.
  6. Cui R, et al. Clinical value of ROMA index in diagnosis of ovarian cancer: meta-analysis. Cancer Manag Res. 2019;11:2545- 2551. doi:10.2147/CMAR.S199400/mdt333.
  7. Bonifácio VD. Ovarian cancer biomarkers: moving forward in early detection. In: Serpa J, ed. Tumor Microenvironment. Advances in Experimental Medicine and Biology. Vol. 1219. Springer; 2020. doi:10.1007/978-3-030-34025-4_18.
  1. Ovarian Cancer Research Alliance. Ovarian cancer recurrence and treatment, OCRA. Available at: https://ocrahope.org/patients/diagnosis-and-treatment/recurrence/ Last accessed: 31 July 2023.
  2. Elias KM, Guo J, Bast RC Jr. Early Detection of Ovarian Cancer. Hematol Oncol Clin North Am. 2018;32(6):903-914. doi:10.1016/j.hoc.2018.07.0039.
  3. Alinity CA 125 [package insert]. May 2022. 701328_R05.
  4. Alinity i HE4 [package insert]. Instructions for use. October 2020. 706347R02.
  5. Alinity i ROMA [package insert]. May 2020. 700100R01.
  6. Braicu, E. I., Krause, C. L., et all. (2022). He4 as a serum biomarker for the diagnosis of pelvic masses: A prospective, Multicenter study in 965 patients. BMC Cancer, 22(1). https://doi.org/10.1186/s12885-022-09887-5.
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