Ciphergen Presents Data Validating Ovarian Cancer Triage Test at Society of Gynecologic Oncologists Annual Meeting
March 05 2007 - 9:00AM
PR Newswire (US)
FREMONT, Calif., March 5 /PRNewswire-FirstCall/ -- Ciphergen
Biosystems, Inc. (NASDAQ:CIPH) presented data from a prospective
clinical trial demonstrating that its ovarian triage test correctly
identified 84 percent of the ovarian cancer cases, compared to only
33 percent identified using standard diagnosis methods without the
test. The poster presentation was made at the Society of
Gynecologic Oncologists 38th Annual Meeting on Women's Cancer in
San Diego, Calif. on Sunday March 4, 2007. Ciphergen and its
collaborators, the Oncologic Clinic Rigshospitalet, University of
Copenhagen, The Danish Cancer Society and The Johns Hopkins Medical
Institutions, 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."
As the table below shows, the seven biomarker assay achieved a
sensitivity of 84 percent, specificity of 80 percent, positive
predictive value of 51 percent, and negative predictive value of 95
percent in the blinded test set. This was compared to a positive
predictive value of 22 percent (the prevalence of cancer in this
population), sensitivity of 33 percent, and specificity of 67
percent in the absence of the assay. Sensitivity Specificity
Positive Negative Predictive Predictive Value Value Without Test
33% 67% 22% 78% CIPH Test Blinded set 84% 80% 51% 95% 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 -- for distinguishing benign from
malignant ovarian tumors. Ciphergen expects to submit the results
of the trial to the U.S. Food and Drug Administration for clearance
as an in vitro diagnostic. Information about enrollment can be
found at http://clinicaltrials.gov/ under the identifier number
NCT00436189. About Ciphergen's Ovarian Cancer Diagnostic Program 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/hematology, 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 projected performance
of Ciphergen's ovarian cancer triage test. Actual results may
differ materially from those projected in such forward-looking
statements due to various factors, including the possibility that
the clinical trial to evaluate the ovarian cancer triage test may
have unexpected or negative results. Investors should consult
Ciphergen's filings with the Securities and Exchange Commission,
including its Form 10-Q filed November 20, 2006, for further
information regarding these and other risks related to the
Company's business. DATASOURCE: Ciphergen Biosystems, Inc. CONTACT:
investors, Sue Carruthers of Ciphergen Biosystems, Inc.,
+1-510-505-2233; or media, Lori Murray of WeissComm Partners,
+1-415-946-1070, for Ciphergen Biosystems, Inc. Web site:
http://www.ciphergen.com/
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