OVA1®

Physicians and Patients: Learn more about OVA1 and other testing services for women's cancers.  

The first blood test FDA cleared to assess the likelihood that an ovarian mass is malignant before it is removed. So you'll have additional information to create an informed treatment plan as early as possible.

Visit our test menu to order OVA1 (test code 16991) or OVA1 with FSH and LH (test code 16992)

 

Why OVA1?

OVA1 is an FDA-cleared blood test that uses results of 5 biomarkers, with an algorithm to indicate the probability of malignancy of an ovarian mass. It is not a screening or standalone test, but when used in conjunction with a standard pre-surgical evaluation this test:

  • Assess the likelihood that an ovarian mass is malignant before it's removed
  • Helps to identify patients for referral to a gynecologic oncologist
  • May enable improved patient outcomes

Contact a sales representative to learn more about our testing services or to become a Quest Diagnostics client.

Intended Use

The OVA1™ Test 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. The OVA1™ Test 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 the OVA1™ Test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

Limitations of the Procedure 

·         A negative OVA1™ Test result, in the setting of a positive pre-surgical assessment, should not preclude oncology referral

·         The OVA1™ Test is not indicated for patients with a diagnosis of malignancy within the last 5 years.

 

Who benefits from Ova1?

OVA1 has been cleared for use in women who meet the following criteria:

  • Are of 18 years of age
  • Have an ovarian adnexal mass
  • Have surgery planned
  • Have not yet been referred to an oncologist
  • Have not had cancer in the past five years
  • Have a rheumatoid factor of less than 250IU/ml

Clinical proof

The OVA1 test was validated using a blood sample from 269 women, 72 of whom had a pathology-determined malignancy. When pre-surgical assessment was combined with results from the OVA1 test, the following results were concluded:[1]

  • Sensitivity for malignancy increased by 20% from 72% to 92% In all women, and as high as 96%in postmenopausal women,
  • Approximately 70% of the malignancies missed by pre-surgical assessment alone were identified by OVA1.
  • A high negative predictive value (NPV-93%) strengthened the prediction that cancer is absent
  • NPV was similar in pre- and postmenopausal women.

Quest Diagnostics offers:

  • An extensive oncology portfolio
  • FDA-cleared tests to help diagnose, monitor treatment, and manage care for women with ovarian cancer
  • A commitment to delivering high-quality, innovative products for every stage of ovarian cancer
  • Consultative services that help set expectations and prepare both physicians and their patients

Make a more informed treatment plan, use OVA1 as part of your comprehensive ovarian cancer diagnostic protocol.

Visit Cancer Diagnostics for Women for additional information about our testing services for ovarian and cervical cancers – including the OVA1 test.

Learn More From A Sales Rep

Contact a physician sales representative to learn more about our testing services, as well as our comprehensive oncology portfolio.

References

1OVA1 [package insert], Fremont, CA: Vermillion, Inc; 2009.