http://www.ova-1.com
Helping Guide Surgical Decisions
Announcing OVA1™
The Landmark Ovarian Cancer Diagnostic Test
OVA1™ is the first and only blood test cleared to help a physician evaluate the likelihood that a woman's ovarian mass is malignant or benign in conjunction with the physician's evaluation prior to a planned surgery
OVA1™ is indicated for use in women who are over 18 years of age; have an ovarian mass present for which surgery is planned; and have not yet been referred to an oncologist
OVA1™ provides new, objective information for physicians referring women to the most appropriate surgeon to operate on their ovarian mass -- potentially helping promote better treatment outcomes.
Developed by Vermillion, Inc., OVA1™ is now available nationally to women and their physicians through Quest Diagnostics.
"Tests such as OVA1™ personalize and improve public health by providing patients and health care providers with more information to support medical decisions that impact survival rates and reduce surgical complications."
Jeffrey Shuren, M.D., J.D.
Acting Director
Center for Devices and Radiological Health
[FDA September 11, 2009 press release]
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. The test is not intended as a screening or stand-alone diagnostic assay.
PRECAUTION: The OVA1™ Test 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.
Vermillion and OVA1 are trademarks of Vermillion, Inc.
|