Vermillion, Inc. (Nasdaq: VRMLD), a molecular diagnostics company,
presented data from several studies demonstrating the benefits of the
Company's ovarian cancer protein biomarker panel. The data suggest that use
of Vermillion's biomarkers could help better identify women with ovarian
cancer, as well as improve the detection of early-stage disease. Results of
these studies were presented at the Society of Gynecologic Oncologists'
(SGO) 39th Annual Meeting on Women's Cancer in Tampa, Florida (Posters 080,
135, 175).
"The data presented today continue to confirm the potential of our
biomarkers to distinguish between benign and malignant tumors and diagnose
early-stage disease," said Eric T. Fung, M.D., Ph.D., Chief Scientific
Officer of Vermillion.
Further Evidence Supporting Ovarian Tumor Triage Test (Poster 135)
A clinical study examining Vermillion's marker panel for ovarian cancer
provided independent validation that it can distinguish malignant tumors
from benign pelvic masses. Results of the study demonstrated that the
biomarker panel could more than double the number of ovarian cancer cases
referred to a gynecologic oncologist, thereby improving survival rates and
reducing the number of surgeries performed.
A model comprising the Company's biomarker panel was trained on a set
of 270 samples from the University of Kentucky. This model was then tested
in a prospectively collected cohort of 709 women from Rigshospitalet in
Copenhagen, Denmark. Vermillion's model demonstrated portability from the
training set to the 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 of
biomarkers in combination with CA-125 could more accurately identify early-
stage ovarian cancer than could CA-125 alone. CA-125 is the only tumor
marker for ovarian cancer currently available on the market; however, it is
not cleared for early-stage disease detection. When examining stage-1
disease, the combination of the two markers correctly identified 87 percent
of the cancers.
The study trained a model on pre-operative serum samples from 231
patients, and then tested the model on pre-operative serum samples from 450
patients. Vermillion worked in collaboration with Robert C. Bast, Jr., M.D.
and colleagues from the University of Texas M.D. Anderson Cancer Center on
this research.
New Ovarian Biomarkers on the Horizon (Poster 175) Another study found
that calgranulin A and B, two proteins commonly found in malignant ovarian
cysts, may be useful in helping diagnose and predict prognosis of ovarian
cancer.
Researchers at Vermillion and the University of Kentucky Chandler
Medical Center used surface enhanced laser desorption ionization
time-of-flight mass spectrometry (SELDI-TOF) to analyze ovarian cyst fluids
and identify the underlying proteins that could serve as potentially useful
biomarkers for ovarian cancer. Fluids from benign (n=45), malignant (n=15),
and low malignant potential (n=13) ovarian tumors were examined. The
calgranulin proteins were increased in malignant ovarian cyst fluids as
compared to benign cyst fluids (p