Ciphergen Presents Data on Novel Biomarkers to Aid in the Differential Diagnosis of a Pelvic Mass at the 37th Annual Meeting fo
March 23 2006 - 9:00AM
PR Newswire (US)
Study Results Demonstrate Substantial Improvement in Positive
Predictive Value FREMONT, Calif., March 23 /PRNewswire-FirstCall/
-- Ciphergen Biosystems, Inc. (NASDAQ:CIPH) announced today results
of a prospective clinical study evaluating the performance of a
multi-marker panel that is designed to help triage women being
evaluated for a persistent pelvic mass or with pelvic pain. This
study was performed in conjunction with Professor Claus Hogdall at
Rigshospitalet, University of Copenhagen. The study evaluated 202
consecutive patients with suspicion of a primary ovarian tumor,
endometriosis or with pelvic pain. Data from 126 women were used
for training, and data from the remaining 76 women were used for
blinded testing. The marker panel, which consists of seven markers
previously identified in studies with The Johns Hopkins School of
Medicine, the University of Texas M. D. Anderson Cancer Center, and
the University of Kentucky, provided substantial benefit in
increased positive predictive value (the percentage of time a
positive test result is actually positive). The marker panel, when
combined with CA125, had a positive predictive value in the blinded
testing set of 80%, in contrast to 59% for CA125 alone. "These
results validate our previous findings in a rigorous, prospective
clinical study," said Gail S. Page, President and CEO of Ciphergen.
"Appropriate triage of women with suspicion of ovarian cancer is
necessary so that women who do have ovarian cancer may be referred
to the specialist gynecologic oncologist. It has been demonstrated
that this referral has an important impact in patient outcome."
According to The American College of Obstetricians and
Gynecologists (ACOG), approximately 5-10% of women in the U.S. will
undergo a surgical procedure for a suspected ovarian neoplasm
during their lifetime. A significant proportion (approximately 20%)
of women with pelvic masses have malignant disease, and the
proportion becomes even higher among post-menopausal women. It has
been demonstrated in several studies, including most recently in
the February 1, 2006 issue of the Journal of the National Cancer
Institute, that early referral to gynecologic oncologists for
laparotomy and appropriate surgical staging of cancer patients
improves survival. The particular study presented today at the SGO
Annual Meeting is part of a comprehensive ovarian cancer program
being conducted by Ciphergen in conjunction with several leading
collaborators at The Johns Hopkins School of Medicine, the
University of Texas M.D. Anderson Cancer Center, University College
London, and the University of Kentucky. In addition to the ongoing
work aimed at developing assays that are designed to distinguish
between benign and malignant pelvic mass, Ciphergen has studies
underway to target the prediction of recurrence of ovarian cancer
as well as to provide additional tools to aid the physician in
triaging women considered at high risk of ovarian cancer. About
Ciphergen Ciphergen is dedicated to the discovery of protein
biomarkers and panels of biomarkers and their development into
protein molecular diagnostic tests that improve patient care; and
to providing collaborative R&D services through its Biomarker
Discovery Center(R) laboratories for biomarker discovery for new
diagnostic tests as well as pharmacoproteomic services for improved
drug toxicology, efficacy and theranostic assays. Ciphergen
develops, manufactures and markets a family of ProteinChip(R)
Systems and services for clinical, research and process proteomics
applications. ProteinChip Systems enable protein discovery,
validation, identification and assay development to provide
researchers with predictive, multi-marker assay capabilities and a
better understanding of biological function at the protein level.
Additional information about Ciphergen can be found at
http://www.ciphergen.com/. Safe Harbor Statement Note Regarding
Forward-Looking Statements: For purposes of the Private Securities
Litigation Reform Act of 1995 (the "Act"), Ciphergen disclaims any
intent or obligation to update these forward-looking statements,
and claims the protection of the Safe Harbor for forward-looking
statements contained in the Act. Examples of such forward-looking
statements include statements regarding the predictive value and
usefulness of the reported multi-marker panel in helping triage
women being evaluated with a persistent pelvic mass or pelvic pain,
the impact on patient outcome of patient referrals to a specialist
gynecologist, the potential outcome of studies designed to predict
recurrence of ovarian cancer and/or to act as a tool to aid a
physician in triaging women considered at high risk of ovarian
cancer, and the ability of Ciphergen to create diagnostic tests to
aid physicians in predicting recurrence of ovarian cancer and/or
triaging women considered at high risk of ovarian cancer. Actual
results may differ materially from those projected in such
forward-looking statements due to various factors, including the
fact that the performance of this or any other multi-marker panel
discovered by Ciphergen may not validate in subsequent studies or
be developed into an assay that is useful to physicians and
patients. Investors should consult Ciphergen's filings with the
Securities and Exchange Commission, including its Form 10-K dated
March 17, 2006, for further information regarding these and other
risks of the Company's business. NOTE: Ciphergen, ProteinChip,
Biomarker Discovery Center and BioSepra are registered trademarks
of Ciphergen Biosystems, Inc. DATASOURCE: Ciphergen Biosystems,
Inc. CONTACT: investors, Sue Carruthers of Ciphergen Biosystems,
Inc., +1-510-505-2297 Web site: http://www.ciphergen.com/
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