FREMONT, Calif., Oct. 16 /PRNewswire-FirstCall/ -- Ciphergen Biosystems, Inc. today announced the presentation of data supporting the use of its protein biomarker panel to discriminate women with ovarian cancer from women with benign pelvic disease. These data are being presented at the International Gynecologic Cancer Society (IGCS) Biennial Meeting in Santa Monica, Calif., October 14-18th.
“Early referral to a gynecologic oncologist for appropriate staging of ovarian cancer patients can improve survival,” said Eric T. Fung, M.D., Ph.D., Chief Scientific Officer for Ciphergen Biosystems. “This study shows that Ciphergen’s protein biomarker panel may be useful in triaging patients being evaluated for ovarian cancer.”
Using a proteomics assay based on SELDI technology, the researchers measured the effectiveness of its biomarker panel in distinguishing women with ovarian cancer samples from those with benign disease. An algorithm comprised of seven validated biomarkers was derived from two sample sets from Leuven Hospital in Belgium (n=61) and the University of Kentucky (n=73) and then applied to pre-operative serum samples from 345 consecutive patients of the Gynecologic Clinic at Rigshospitalet in a prospective clinical trial. Because it has been shown that approximately 33% of women with ovarian cancer are referred to gynecologic oncologists,(1) sensitivity, specificity and positive predictive value were calculated with and without the marker panel at this assumed rate of referral. Without the marker panel, the sensitivity was 34%, specificity was 67%, and positive predictive value was 22%. The marker panel increased sensitivity to 76%, specificity to 80%, and positive predictive value to 54%.
The poster was presented on Sunday, October 15, 2006 from 12:30-1:30 p.m. during Poster Session 1: Ovarian in the Exhibition Area.
Title: A Panel of Seven Biomarkers Improves Specificity in Discriminating Malignant from Benign Pelvic Masses
Collaborators: The Danish Cancer Society, John Hopkins Medical Institutions, University of Copenhagen
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 (update)
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 pelvic disease 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) Earle et al, JNCI, vol 98, p. 172-80, 2006
Ciphergen Biosystems, Inc.
CONTACT: Investor Relations, Sue Carruthers of Ciphergen Biosystems, Inc.,+1-510-505-2233; or Andrea Campbell of WeissComm Partners, +1-281-360-7239,for Ciphergen
Web site: http://www.ciphergen.com//
