OVA1^® is the first blood test cleared to help a physician evaluate the likelihood that an ovarian adnexal mass is malignant or benign prior to a planned surgery.

OVA1 provides new, objective information to help physicians refer women to the most appropriate surgeon— potentially helping to promote better treatment outcomes.

Only an estimated one-third of women with a suspicious mass are referred to gynecologic oncologists for their initial surgery.¹ In many cases, an OB/GYN will operate to explore an ovarian adnexal mass — only to find a malignancy that she or he will then refer to a gynecologic oncologist for removal. Not surprisingly, leading medical associations, including the National Comprehensive Cancer Network and the Society of Gynecologic Oncologists, recommend that women with an ovarian adnexal mass suspicious for cancer be referred to a gynecologic oncologist for surgery.

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

• Helps assess the likelihood an ovarian adnexal mass is malignant before removal
• Helps to identify patients for referral to gynecologic oncologists
• May lead to improved patient outcomes

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

OVA1 is not intended to be a screening test or to determine whether a patient should proceed to surgery.

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

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 is not intended as a screening or stand-alone diagnostic assay. Incorrect use of OVA1 carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

*FDA clearance does not denote official approval.