Vermillion's Biomarkers Prove Beneficial in Identifying Women With Ovarian Cancer and Detecting Early-Stage Disease

Tuesday, March 11, 2008 General News
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FREMONT, Calif. and TAMPA, Fla., March 10 Vermillion, Inc. (Nasdaq: VRMLD), a molecular diagnostics company, presenteddata from several studies demonstrating the benefits of the Company's ovariancancer protein biomarker panel. The data suggest that use of Vermillion'sbiomarkers could help better identify women with ovarian cancer, as well asimprove the detection of early-stage disease. Results of these studies werepresented at the Society of Gynecologic Oncologists' (SGO) 39th Annual Meetingon Women's Cancer in Tampa, Florida (Posters 080, 135, 175).

"The data presented today continue to confirm the potential of ourbiomarkers to distinguish between benign and malignant tumors and diagnoseearly-stage disease," said Eric T. Fung, M.D., Ph.D., Chief Scientific Officerof Vermillion.

Further Evidence Supporting Ovarian Tumor Triage Test (Poster 135)

A clinical study examining Vermillion's marker panel for ovarian cancerprovided independent validation that it can distinguish malignant tumors frombenign pelvic masses. Results of the study demonstrated that the biomarkerpanel could more than double the number of ovarian cancer cases referred to agynecologic oncologist, thereby improving survival rates and reducing thenumber of surgeries performed.

A model comprising the Company's biomarker panel was trained on a set of270 samples from the University of Kentucky. This model was then tested in aprospectively collected cohort of 709 women from Rigshospitalet in Copenhagen,Denmark. Vermillion's model demonstrated portability from the training set tothe validation set, which is a critical step in diagnostic test development.

Positive Results in Early-Stage Disease Detection (Poster 080)

The ovarian cancer detection study showed that Vermillion's panel ofbiomarkers in combination with CA-125 could more accurately identify early-stage ovarian cancer than could CA-125 alone. CA-125 is the only tumor markerfor ovarian cancer currently available on the market; however, it is notcleared for early-stage disease detection. When examining stage-1 disease, thecombination of the two markers correctly identified 87 percent of the cancers.

The study trained a model on pre-operative serum samples from 231patients, and then tested the model on pre-operative serum samples from 450patients. Vermillion worked in collaboration with Robert C. Bast, Jr., M.D.and colleagues from the University of Texas M.D. Anderson Cancer Center onthis research.

New Ovarian Biomarkers on the Horizon (Poster 175)Another study found that calgranulin A and B, two proteins commonly found inmalignant ovarian cysts, may be useful in helping diagnose and predictprognosis of ovarian cancer.

Researchers at Vermillion and the University of Kentucky Chandler MedicalCenter used surface enhanced laser desorption ionization time-of-flight massspectrometry (SELDI-TOF) to analyze ovarian cyst fluids and identify theunderlying proteins that could serve as potentially useful biomarkers forovarian cancer. Fluids from benign (n=45), malignant (n=15), and lowmalignant potential (n=13) ovarian tumors were examined. The calgranulinproteins were increased in malignant ovarian cyst fluids as compared to benigncyst fluids (p<0.001).

About Vermillion's Ovarian Cancer Diagnostic Program

Vermillion has multiple ovarian cancer diagnostic tests in development.The most advanced of Vermillion's programs is the Ovarian Tumor Triage Test,which utilizes a panel of biomarkers to help identify women with cancer sothey can be referred to a gynecologic oncologist for their initial surgery.Vermilion intends to submit clinical trial data on the Ovarian Tumor Triage

Test to the U.S. Food and Drug Administration for clearance as an in vitrodiagnostic test in the first half of 2008.

Additionally, studies are underway to detect early-stage ovar

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