Ciphergen Announces Data Supporting the Use of Protein Biomarkers to Improve Patient Diagnosis for Ovarian Cancer
September 21 2006 - 10:00AM
PR Newswire (US)
FREMONT, Calif., Sept. 21 /PRNewswire-FirstCall/ -- Ciphergen
Biosystems, Inc. (NASDAQ:CIPH) today announced the publication of
data validating the use of its protein biomarkers to discriminate
women with ovarian cancer from women with benign ovarian tumors and
other non-gynecologic diseases. The data appear in the current
issue of Cancer Epidemiology, Biomarkers & Prevention. "New
biomarkers that improve the diagnostic performance of existing
tumor markers for ovarian cancer are critically needed," said Eric
T. Fung, M.D., Ph.D., Chief Scientific Officer for Ciphergen
Biosystems. "These results further validate Ciphergen's panel of
biomarkers, which we believe can help differentiate women with
ovarian cancer from women with benign disease." Using proteomic
profiling based on SELDI technology, this study successfully
reproduced findings from an earlier study(1) in an independent
study population. Unlike the earlier study that compared women with
ovarian cancer and healthy controls, this study evaluated the power
of the markers to discriminate 42 women with ovarian cancer from 65
women with benign ovarian tumors and 76 women with gastrointestinal
disorders. A class prediction algorithm using the markers in
combination with age had specificity of 94.3% and sensitivity of
78.6%. As in the previous study, this study demonstrated that these
markers improved specificity in distinguishing ovarian cancer from
other diseases, including benign ovarian disease. About Ciphergen's
Ovarian Cancer Diagnostic Program Ciphergen has an advanced
diagnostic program in ovarian cancer and has developed a panel of
biomarkers that provides risk stratification information for
ovarian cancer based on a series of studies involving over 2,000
clinical samples from more than five sites. Ciphergen has an
alliance with Quest Diagnostics to commercialize this marker set
under the analyte specific reagent, or ASR, regulations. Ciphergen
is simultaneously undertaking a prospective clinical trial to
support submission to the FDA for approval as an in vitro
diagnostic test. In addition to developing a diagnostic designed to
distinguish between benign and malignant pelvic masses, studies are
underway to predict recurrence of ovarian cancer and to provide
additional tools to aid physicians in triaging women considered at
high risk of ovarian cancer. Ciphergen's comprehensive diagnostic
development program is being conducted 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. About Ovarian Cancer
Commonly known as the "silent killer," ovarian cancer leads to
approximately 14,000 deaths each year in the United States.
Approximately 23,000 new cases are diagnosed each year, with the
majority in patients diagnosed with late stage disease where the
cancer has spread beyond the ovary. The prognosis is poor in these
patients, leading to the high mortality from this disease. A
diagnostic test is needed that can provide adequate predictive
value to stratify patients with a pelvic mass into high risk of
invasive ovarian cancer versus those with low risk. About Ciphergen
Ciphergen Biosystems, Inc. is dedicated to the discovery,
development and commercialization of novel high-value diagnostic
tests that help physicians diagnose, treat and improve outcomes for
patients. Ciphergen, along with its prestigious scientific
collaborators, has ongoing diagnostic programs in oncology,
cardiology and women's health with an initial focus in ovarian
cancer. Based in Fremont, California, more information about
Ciphergen can be found on the Web at http://www.ciphergen.com/ .
Safe Harbor Statement Note Regarding Forward-Looking Statements:
This press release contains 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 use of protein biomarkers to discriminate women with
ovarian cancer from benign ovarian tumors and other non-gynecologic
disease, the predictive value and usefulness of protein biomarkers
in helping triage women being evaluated with a persistent pelvic
mass or pelvic pain, 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 successfully commercialize
diagnostic tests to aid physicians in diagnosing ovarian cancer,
predicting recurrence of ovarian cancer and/or triaging women who
present with a pelvic mass or are 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 possibility that the biomarker panel
described in this publication or any other biomarker panel
discovered by Ciphergen may not validate in subsequent studies or
be developed into an assay that is useful to physicians and
patients and the risk that Ciphergen may not predict successfully
the recurrence of ovarian cancer and be able to provide additional
tools to aid physicians in triaging women considered at high risk
of ovarian cancer. Investors should consult Ciphergen's filings
with the Securities and Exchange Commission, including its Form
10-Q filed August 16, 2006, for further information regarding these
and other risks related to the Company's business. NOTE: Ciphergen,
ProteinChip and Biomarker Discovery Center are registered
trademarks of Ciphergen Biosystems, Inc. (1)Zhang Z, Bast RC, Jr.,
Yu Y, et al. Three biomarkers identified from serum proteomic
analysis for the detection of early stage ovarian cancer. Cancer
Res 2004; 64: 5882-90. DATASOURCE: Ciphergen Biosystems, Inc.
CONTACT: investors, Sue Carruthers of Ciphergen Biosystems, Inc.,
+1-510-505-2233; or media, Lori Murray, WeissComm Partners,
+1-415-946-1070, for Ciphergen Biosystems, Inc. Web site:
http://www.ciphergen.com/
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