Physician Overview

OVA1 Answers Your Questions

1. What is the OVA1 test? OVA1 is an FDA-cleared* blood test to help evaluate an ovarian mass for cancer prior to a planned surgery.

2. What does OVA1 do? In conjunction with clinical evaluation of women age 18 and older who have an ovarian mass and planned surgery, OVA1 can help triage according to probability of malignancy.

3. How does OVA1 help me manage patients? With 96% sensitivity, OVA1 may help refer cancers to oncology specialists while its 95% NPV helps ensure that benign cases can be confidently treated in the local setting.¹

4. What type of malignancies can OVA1 identify? OVA1 has 96% sensitivity for a broad range of ovarian cancers, including EOC, non-EOC, and LMP.

Who May Benefit from OVA1?

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

• Are over 18 years of age
• Have an ovarian adnexal mass
• Have surgery planned
• Have not yet been referred to a gynecologic oncologist
• Have not had cancer in the past five years; and
• Have a rheumatoid factor concentraction <250 IU/mL

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

Instructions for Use

OVA1® is a qualitative serum test that combines the results of 5 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 surgery, and/or delayed diagnosis.