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Yes
No

OVA-1
Test code(s) 16991, 16992


Question 1. What are the five analytes used to calculate OVA1®?

  • CA 125 (increased in ovarian tumors)
  • Apolipoprotein A1 (decreased in ovarian tumors)
  • Beta-2 microglobulin (increased in ovarian tumors)
  • Transferrin (decreased in ovarian tumors)
  • Pre-albumin (decreased in ovarian tumors)

Question 2. How does one calculate the OVA1® score?

This is a proprietary formula owned by Vermillon. We submit our analyte values to them and they calculate the score, which ranges from 0 to10.

Question 3. Is the OVA1® a screening test ?

No. The FDA has approved the use of OVA1 in a very specific setting: “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.”1

Question 4. Why doesn’t Quest Diagnostics report the analyte results with the score ?

Quest Diagnostics has been informed by Vermillion, the developer and vendor of the OVA1 test, that the FDA has indicated to them that the only result that should be reported to the ordering physician is the result of the algorithm calculation, the OVA1 score, and that the individual results of the five component assays which are used to calculate the score should not be reported.

Question 5. OVA1® is elevated in what types of cancer?

The data indicate that the OVA1 score is likely elevated in primary epithelial ovarian malignancies. Benign epithelial tumors, stromal tumors, germ cell tumors, or metastatic tumors may not be associated with an elevated score.

Question 6. How well does OVA1® predict ovarian cancer compared to CA-125 alone?

Data shown in Table 1 are based on two different cutoff values for CA 125: 1) 200 U/mL, the cutoff recommended by ACOG and 2) 67 U/mL, the cutoff recommended by Dearking.  Please note that CA125 is not FDA-cleared for this indication.

Question 7. Are there any non-cancerous conditions that can result in an elevated OVA1 score?

Yes, several non-cancerous conditions were studied and the range of OVA1 scores, extracted from the product insert, are listed in the table below.

 

References

  1. OVA1TM Product Insert. V2.0: 01Jan10. Vermillion, Inc.
  2. Ueland, et al. Obstet Gynecol. 2011:117(6):1289-1297.
  3. Miller, et al. Obstet Gynecol. 2011;117(6):1298-1306.
This FAQ is provided for informational purposes only and is not intended as medical advice. A physician’s test selection and interpretation, diagnosis, and patient management decisions should be based on his/her education, clinical expertise, and assessment of the patient.
Document Number: FAQS.02 Version: 1
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