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The OVA1 Test Improves the Preoperative Assessment of Ovarian Tumors

The OVA1 Test Improves the Preoperative Assessment of Ovarian Tumors. Frederick Ueland, Chris Desimone, Leigh Seamon, Rachel Ware, Scott Goodrich, Iwona Podzielinski, Lori Sokoll, Alan Smith, Joseph Santoso, John R. van Nagell Jr., Zhen Zhang. NIH Consensus Statement 1994.

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The OVA1 Test Improves the Preoperative Assessment of Ovarian Tumors

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  1. The OVA1 Test Improves the Preoperative Assessment of Ovarian Tumors Frederick Ueland, Chris Desimone, Leigh Seamon, Rachel Ware, Scott Goodrich, Iwona Podzielinski, Lori Sokoll, Alan Smith, Joseph Santoso, John R. van Nagell Jr., Zhen Zhang.

  2. NIH Consensus Statement1994 “Women with ovarian masses who have been identified preoperatively as having a significant risk of ovarian cancer should be given the option of having their surgery performed by a gynecologic oncologist”

  3. The OVA1 Test • Biomarker panel • CA125, transthyretin (prealbumin), apolipoprotein A1 beta 2 microglobulin, transferrin • OvaCalc software algorithm • OVA1 risk index, range 0-10

  4. Objectives Evaluate the performance of the OVA1 test alone, and in conjunction with current clinical parameters, in estimating the risk of malignancy in women scheduled for surgery with an ovarian mass.

  5. Eligibility • Female subjects age 18 years or older • Agreeable to phlebotomy • Documented ovarian tumor on imaging • Planned surgical intervention within 3 months of imaging • Signed informed consent

  6. Methods • 27 primary care and specialty sites throughout U.S. • Preoperative evaluation • imaging to confirm ovarian tumor • serum collection for CA125 • physician assessment (cancer? “yes or no”) • Centralized assay at Quest Diagnostics • Validation assays • Johns Hopkins • Specialty Laboratories • Independent data analysis • Applied Clinical Intelligence

  7. Receiving-operator-characteristic Curve OVA1 Test Alone

  8. OVA1 Sensitivity Tumor subtype Cancer stage

  9. Conclusions • The OVA1 test successfully classifies patients into high or low probability of malignancy. • OVA1 has high sensitivity in premenopausal women and all stages of epithelial ovarian cancers. These results are independent of physician specialty. • When combined with other clinical information, the OVA1 test can help determine the risk of malignancy for an ovarian tumor before surgery, and facilitate decisions about referral to a gynecologic oncologist.

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