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The OVA1® Test

OVA1® is a simple blood test cleared* by the FDA to help physicians assess the likelihood an ovarian mass is malignant prior to a planned surgery. It is not a screening test, yet OVA1® is to be used together with a physician’s overall assessment to help guide referral decisions for the patient.

OVA1® measures the levels of five proteins found in the blood and then uses a proprietary software called OvaCalc® to calculate a single score. A woman’s risk of cancer is measured by using a 0-10 scale versus predetermined cut-off points. Women who are pre-menopausal have a cut off of 5.0 whereas postmenopausal women have a 4.4 cutoff. A high OVA1® score is not a diagnosis of cancer, rather it indicates an increased risk.

An elevated OVA1® test score may help the physician determine if the woman should be referred to a gynecologic oncologist. A gynecologic oncologist is a gynecologist who has undergone extensive training and specializes in gynecological cancers. Studies have shown that women with ovarian malignancies can experience better outcomes when they are operated on by a gynecologic oncologist.

In the validation study of OVA1 reported by Dr. Frederick Ueland from the University of Kentucky, Markey Cancer Center in 2011, dual assessment (OVA1® + Clinical Impression), the sensitivity for malignancy was 95.7%, compared to only 75.1% without OVA1®. Generally speaking, sensitivity refers to the percentage of individuals with cancer in whom a test correctly identifies the malignancy. Moreover, of the patients identified as low risk by OVA1® + Clinical Impression, 94.7% proved to be benign.1

When used in conjunction with a standard pre-surgical evaluation, OVA1® may:

  • Help assess the likelihood an ovarian adnexal mass is malignant before surgery
  • Help to identify patients for referral to gynecologic oncologists
  • Increase the likelihood of optimal surgery, treatment and follow up for ovarian cancer patients

OVA1® has been FDA cleared for use in women meeting the following criteria:

  • Over 18 years of age
  • Have an ovarian adnexal mass
  • Have surgery planned
  • Have not yet been referred to a gynecologic oncologist; and
  • Have not had cancer in the past five years

Visit www.ova-1.com for full prescribing information

INTENDED USE: OVA1® is a qualitative serum test that combines the results of five immunoassays into a single numerical 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. OVA1® 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.

PRECAUTION: OVA1® 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 OVA1® carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

*FDA clearance does not denote official approval.

1 Ueland, FR, et al,. Effectiveness of a Multivariate Index Assay in the Preoperative Assessment of Ovarian Tumors, Obstet Gynecol 2011;117:1289-97

2 Bristow, RE et al. Ovarian Malignancy Risk Stratification of the Adnexal Mass Using a Multivariate Index Assay, Gynecologic Oncology 128 (2013) 252–259

3 R Miller, et al Performance of the American College of Obstetricians and Gynecologists’ Ovarian Tumor Referral Guidelines With a Multivariate Index Assay” Obstet Gynecol 2011;117:1298–306

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