Effective Date:

a)    This policy will apply to all services performed on or after the above Revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

OVA-1 requires pre-authorization.

The OVA-1 test is a blood test that combines several other tests into a single score.  This test is covered only for certain women planning to undergo surgery for a pelvic mass that appears to be benign.  The test is indicated only if a positive test would lead to referral to a gynecologic oncologist prior to surgery.

If this test does not meet standards for medical necessity, the patient may be responsible for the entire cost of the test.

The proteomics-based OVA1™ test is covered as an aid to further assess the likelihood that malignancy is present when the physician’s (other than gynecologic oncologist) independent clinical and radiological preoperative evaluations do not indicate malignancy in a patient with an ovarian (adnexal) mass who meets ALL of the following criteria:

1)    Older than 18 years;

2)    Adnexal, presumed ovarian, mass present;

3)    Surgery is planned for treatment of the mass;

4)    The patient has not been referred to a gynecologic oncologist;

5)    A positive test would lead to referral to a gynecologic oncologist prior to surgery.

Codes Used In This BI:

81503             Oncology (ovarian), biochemical assays of five proteins

82172             Assay of apolipoprotein

82232             Assay of beta-2 protein

84134             Assay of prealbumin

84466             Assay of transferring

86304             Immunoassay tumor ca 125

OVA1™ is considered investigational for any other use, including screening for ovarian cancer, selecting patients with an adnexal mass for surgery, evaluation of patients with clinical or radiological evidence of malignancy, or detection of recurrent malignant disease following surgery.

A recipe for proteomics diagnostic test development: the OVA1™ test from biomarker discovery to FDA clearance. Clin Chem 2010; 56(2):327-9.

ACOG Committee Opinion: number 280, December 2002. (2002) The role of the generalist obstetrician-gynecologist in the early detection of ovarian cancer. Obstet Gynecol 2002; 100(6):1413-6.

Alcazar JL, Rodriguez D.(2009) Three-dimensional power Doppler vascular sonographic sampling for predicting ovarian cancer in cystic-solid and solid vascularized masses. J Ultrasound Med 2009; 28(3):275-81.

Andersen MR, Goff BA, Lowe KA et al.(2009) Combining a symptom index with CA 125 to improve detection of ovarian cancer. Cancer 2009; 113(3):484-9.

Andersen MR, Goff BA, Lowe KA et al.(2010) Use of a Symptom Index, CA125, and HE4 to predict ovarian cancer. Gynecol Oncol 2010; 116(3):378-83.

Bristow RE, Zahurak ML, Diaz-Montes TP et al.(2009) Impact of surgeon and hospital ovarian cancer surgical case volume on in-hospital mortality and related short-term outcomes. Gynecol Oncol 2009; 115(3):334-8.

Dearking AC, Aletti GD, McGree ME et al. (2007) How relevant are ACOG and SGO guidelines for referral of adnexal mass? Obstet Gynecol 2007; 110(4):841-8.

du Bois A, Rochon J, Pfisterer J et al.(2009) Variation in institutional infrastructure, physician specialization and experience, and outcome in ovarian cancer: a systematic review. Gynecol Oncol 2009; 112(2):422-36.

Giede KC, Kieser K, Dodge J et al.(2005) Who should operate on patients with ovarian cancer? An evidence-based review. Gynecol Oncol 2005; 99(2):447-61.

Goff BA, Matthews BJ, Larson EH et al. (2007) Predictors of comprehensive surgical treatment in patients with ovarian cancer. Cancer 2007; 109(10):2031-42.

Hoskins W, Rice L, Rubin S. (1997) Ovarian cancer surgical practice guidelines. Oncology 1997; 11(6):896-904.

Muller CY. (2010) Doctor, should I get this new ovarian cancer test-OVA1? Obstet Gynecol 2010; 116(2 Pt 1):246-7.

Tingulstad S, Skjeldestad FE, Hagen B. (2003) The effect of centralization of primary surgery on survival in ovarian cancer patients. Obstet Gynecol 2003; 102(3):499-505.

U.S. Food and Drug Administration. 510(k) Substantial Equivalence Determination Decision Summary: OVA1™ Test (K081754). Available online at: http://www.accessdata.fda.gov/cdrh_docs/reviews/K081754.pdf. Last accessed May 2010.

Ueland F, DeSimone C, Seamon L et al. (2010) The OVA1 test improves the preoperative assessment of ovarian tumors. Gynecol Oncol 2010; 116(3 suppl 1):S23.

Van Holsbeke C, Van Belle V, Leone F et al. (2010) Prospective external validation of the “ovarian crescent sign” as a single ultrasound parameter to distinguish between benign and malignant adnexal pathology. Ultrasound Obstet Gynecol 2010 [E-pub ahead of print].

Vernooij F, Heintz P, Witteveen E et al. (2007) The outcomes of ovarian cancer treatment are better when provided by gynecologic oncologists and in specialized hospitals: a systematic review. Gynecol Oncol 2007; 105(3):801-12.

Zhang Z, Chan DW. (2010) The road from discovery to clinical diagnostics: lessons learned from the first FDA-cleared in vitro diagnostic multivariate index assay of proteomic biomarkers. Cancer Epidemiol Biomarkers Prev 2010; 19(12):2995-9.