Objective: To assess the use of Multivariate Index Assay (MIA OVA1) by gynecologists and determine referral practices and surgical decision making for women with adnexal masses and low-risk MIA OVA1 scores.
Methods: Information on patients who received an OVA1 test was collected retrospectively from 22 gynecologic practices through a chart review. Referral patterns were examined for patients with low-risk OVA1 results prior to first surgical intervention. Chart reviews were from a variety of practice and hospital settings representing major geographic regions within the United States.
Results: A total of 282 independent patient charts were reviewed. Low-risk results were found for 146 patients (52%). Surgery was performed on 82 (56%) patients with low-risk scores. The referral rate to specialty care was 21% (17/82) for low-risk OVA1 patients. Three low-malignant potential tumors were identified in the low-risk patients, with no cases of invasive malignancy. Eighty-six percent of the surgeries performed on low-risk OVA1 patients were minimally invasive. In 44% of the low-risk OVA1 patients, no surgical intervention was performed.
Conclusions: A high proportion of low-risk OVA1 patients were not referred to a gynecologic oncologist prior to surgery, indicating gynecologists may use MIA OVA1 along with clinical and radiographic findings to appropriately retain patients for their care. This practice is safe and may be cost-saving, with patient satisfaction implications.
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http://dx.doi.org/10.1080/03007995.2020.1842726 | DOI Listing |
J Comp Eff Res
June 2023
Baker Tilly US, LLP, New York, NY 10119, USA.
This largest-of-its-kind study evaluated the clinical utility of CA125 and OVA1, commonly used as ovarian tumor markers for assessing the risk of malignancy. The research focused on the ability and utility of these tests to reliably predict patients at low risk for ovarian cancer. Clinical utility endpoints were 12-month maintenance of benign mass status, reduction in gynecologic oncologist referral, avoidable surgical intervention and associated cost savings.
View Article and Find Full Text PDFInt J Gynaecol Obstet
August 2023
Aspira Women's Health, Inc., Trumbull, Connecticut, USA.
Objectives: Patients with adnexal masses suspicious for malignancy benefit from referral to oncology specialists during presurgical assessment of the mass. OVA1 is a multivariate assay using a five-biomarker panel which offers high overall and early-stage sensitivity. However, OVA1 has a high false-positive rate for benign masses.
View Article and Find Full Text PDFDiagnostics (Basel)
August 2021
Division of Gynecologic Oncology, University of Kentucky Markey Cancer Center, Lexington, KY 40536, USA.
Background: Ovarian cancer is the deadliest gynecologic cancer, with no recommended screening test to assist with early detection. Cancer antigen 125 (CA125) is a serum biomarker commonly used by clinicians to assess preoperative cancer risk, but it underperforms in premenopausal women, early-stage malignancies, and several histologic subtypes. OVA1 is a multivariate index assay that combines CA125 and four other serum proteins to assess the malignant risk of an adnexal mass.
View Article and Find Full Text PDFCurr Med Res Opin
December 2020
Calliope LLC, Austin, TX, USA.
Objective: To assess the use of Multivariate Index Assay (MIA OVA1) by gynecologists and determine referral practices and surgical decision making for women with adnexal masses and low-risk MIA OVA1 scores.
Methods: Information on patients who received an OVA1 test was collected retrospectively from 22 gynecologic practices through a chart review. Referral patterns were examined for patients with low-risk OVA1 results prior to first surgical intervention.
Am J Obstet Gynecol
July 2014
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Markey Cancer Center, University of Kentucky, Lexington, KY. Electronic address:
Objective: The purpose of this study was to investigate the relationship between imaging and the multivariate index assay (MIA) in the prediction of the likelihood of ovarian malignancy before surgery.
Study Design: Subjects were recruited in 2 related prospective, multiinstitutional trials that involved 44 sites across the United States. Women had ovarian imaging, biomarker analysis, and surgery for an adnexal mass.
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