Ovarian Cancer Triage Test Validated

In a clinical trial an ovarian triage test correctly identified 84% of the ovarian cancer cases, compared to only 33% identified using standard diagnosis methods without the test.

The seven-biomarker assay achieved a sensitivity of 84%, specificity of 80%, positive predictive value of 51%, and negative predictive value of 95% in the blinded test set. This was compared to a positive predictive value of 22% (the prevalence of cancer in this population), sensitivity of 33%, and specificity of 67% in the absence of the assay.

The trial was conducted by Ciphergen Biosystems (Fremont, CA) with the Oncologic Clinic Rigshospitalet at the University of Copenhagen (Denmark), The Danish Cancer Society (Copenhagen, Denmark), and The Johns Hopkins Medical Institutions (Baltimore, MD, USA). They analyzed pre-operative serum samples from 525 consecutive patients.

This prospective clinical trial validated that these markers improved both sensitivity and specificity in distinguishing ovarian cancer from benign pelvic masses, said Eric T. Fung, M.D., Ph.D., chief scientific officer for Ciphergen Biosystems. Previous studies have demonstrated that early referral to gynecologic oncologist for diagnosis and appropriate surgical staging of cancer patients improves survival. In this study, given the historical referral rate to gynecologic oncologists of 33 percent of pelvic masses, this test could have more than doubled the ovarian cancer cases referred to the gynecologic oncologist.

Ciphergen presented data from the prospective clinical trial at the Society of Gynecologic Oncologists 38th Annual Meeting on Women's Cancer in San Diego (CA, USA) on March 4, 2007.

In addition to this completed prospective clinical trial, Ciphergen is currently enrolling patients in a clinical trial that seeks to demonstrate that the positive predictive value of the Ciphergen ovarian triage test is better than the current standard of care--physical and radiological exam--or distinguishing benign from malignant ovarian tumors. Ciphergen expects to submit the results of the trial to the U.S. Food and Drug Administration (FDA) for clearance as an in vitro diagnostic.


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