Analysis of Proteomic Patterns in Serum to Identify Ovarian Cancer
DESCRIPTION
Proteins are the functional units of cells and represent the end product of the interactions among the underlying genes. Proteomics is the study of all protein forms expressed within an organism as a function of time, age, state, and external factors. Cancer research has identified a pattern of proteins present in different body fluids, such as body fluid or serum that are associated with an underlying cancer. Identification of patterns of proteins in the serum could function as serum tumor markers, similar in concept to the prostate specific antigen (PSA) or CA-125, which are used in the detection and monitoring of prostate and ovarian cancer.
CA-125 and transvaginal ultrasound have been proposed as screening techniques for ovarian cancer, particularly in high-risk individuals. However, they have not resulted in a decrease in morbidity, primarily due to the advanced disease stage at diagnosis and the lack of curative therapies at these stages.
The OvaCheck™ (Correlogic Systems) is the first test based on serum proteomic patterns, which are further analyzed with the use of a mass spectrometer to profile groups of proteins based on their size and electrical charge. Patterns are identified that are consistent with ovarian cancer. The manufacturer originally assumed that this test would not be subject to FDA approval. However, the FDA has questioned this assumption. To date, it has not received FDA approval.
Laboratory Corporation of America (LabCorp) introduced OvaSure™, another screening test for the early detection of ovarian cancer. To date, this test has not received FDA approval, however, according to the literature, the test is undergoing further evaluation in a phase III clinical trial in collaboration with the National Cancer Institute’s Early Detection Research Network.
POLICY
Analysis of proteomic patterns in serum for screening and detection of ovarian cancer is considered investigational.
ADDITIONAL INFORMATION
In February 2004, the Society of Gynecologic Oncologists (SGO) released the following statement on OvaCheck™:
"The Society of Gynecologic Oncologists recognizes the importance of accurate early detection biomarkers for ovarian cancer. For this reason SGO reviewed the literature regarding OvaCheck™, a serum based diagnostic test for ovarian cancer. In the opinion of SGO, more research is needed to validate the test's effectiveness before offering it to the public. The SGO is committed to actively following and contributing to this vitally important research. As physicians who care only for women with gynecologic cancer, our hope is that these cancers can either be prevented or detected early. Because no test now exists to routinely detect ovarian cancer in its earliest and most curable stage, we will await the results of further clinical validation of OvaCheck™ with great interest."
There has been no update of this statement to date.
In July 2008, the Society of Gynecologic Oncologist (SCO) released the following statement on OvaSure™:
“The Society of Gynecologic Oncologist (SGO) recognizes the need for accurate early detection biomarkers for ovarian cancer. For this reason, SGO reviewed the literature regarding OvaSure™, a serum-based diagnostic test for ovarian cancer. After reviewing OvaSure’s materials, it is our opinion that additional research is needed to validate the test’s effectiveness before offering it to women outside of the context of a research study conducted with appropriate informed consent under the auspices of an institutional review board. SGO is committed to actively following and contributing to this vitally important research. As physicians who care only for women with gynecologic cancers, our hope is that cancers can either be prevented or detected early. Because no currently available test has been shown to reliably detect ovarian cancer in its earliest and most curable stages, we will await the results of further clinical evaluation of OvaSure™ with great interest.”
Risk factors for ovarian cancer, detailed in the literature include, but are not limited to:
Family history
Nulliparity
Early menarche
Late menopause
Increasing age
Published scientific evidence in the form of well-designed studies in peer-reviewed journals regarding the analysis of proteomic patterns in serum to identify ovarian cancer is lacking. There is insufficient evidence to permit conclusions regarding the use of this technology or benefits compared to established alternative screening methods for ovarian cancer.
SOURCES
Abeloff, M. D., Armitage, J. O., Niederhuber, J. E., Kastan, M. B., & McKenna, W. G. (2008). Clinical Oncology (4th ed., pp. 1828-1848). Philadelphia: Churchill Livingstone Elsevier.
Agency for Healthcare Research and Quality. (2006, October). Genomic tests for ovarian cancer detection and management. Retrieved March 27, 2007 from http://www.ahrq.gov/downloads/pub/evidence/pdf/genomicovc/genovc.pdf.
American Cancer Society. (2008). What’s new in ovarian cancer research and treatment? Retrieved April 14, 2009 from http://www.cancer.org/docroot/CRI/content/CRI_2_4_6X_Whats_new_in_ovarian_cancer_research_and_treatment_33.asp?sitearea=.
BlueCross BlueShield Association. Medical Policy Reference Manual. (2007, May). Analysis of proteomic patterns in serum to identify ovarian cancer (2.04.34). Retrieved April 13, 2009 from BlueWeb.
Chobanian, N. & Dietrich, C.S. (2008). Ovarian Cancer. Surgical Clinics of North America, 88 (2), 285-29.
Conrads, T.P., Fusaro, V.A., Ross, S., Johann, D., Vajapakse, V., Hitt, B.A., et al. (2004). High-resolution serum proteomic features for ovarian cancer detection. Endocrine-Related Cancer, 11 (4), 163-178.
Dann, R.B., Kelley, J.L., & Zorn, K.K. (2007). Strategies for ovarian cancer prevention. Obstetrics and Gynecology Clinics of North America, 34 (4), 667-686.
Eastman, P. (2008). NCI scientist warns against premature use of diagnostic tests for ovarian cancer. Oncology Times, 30 (15), 28-29.
National Cancer Institute. (2005, September). Proteomics and Cancer: Fact Sheet. Retrieved April 14, 2009 from http://www.cancer.gov/cancertopics/factsheet/proteomicsqa.
National Cancer Institute. (2005, September). The FNC/FDA proteomics research program, its research, and diagnostic tests by private industry (e.g., OvaCheck™): fact sheet. http://www.cancer.gov/cancertopics/factsheet/nci/ovacheck-proteomics.
National Cancer Institute. (2008). National Cancer Bulletin- FDA takes action on ovarian cancer screening test. Retrieved April 14, 2009 from http://www.cancer.gov/ncicancerbulletin/NCI_Cancer_Bulletin_102108.pdf.
National Institutes of Health. (2003, April). Proteomics research aids cancer diagnosis and treatment. Retrieved November 16, 2004 from http://www.nih.gov/news/pr/apr2003/nci-09.htm.
Nossov, V., Amneus, M., Su, F., Lang, J, Tran Janco, J.M.,Reddy, S.T., et al. (2008). The early detection of ovarian cancer: from traditional methods to proteomics. Can we really do better than serum CA-125? American Journal of Obstetrics & Gynecology, 199 (3), 215-223.
Petricoin, E. F., Ardekani, A. M., Hitt, B. A., Levine, P. J., Fusaro, V. A., Steinberg, S. M. et al. (2002). Use of proteomic patterns in serum to identify ovarian cancer. The Lancet, 359 (9306), 572-577.
Ransohoff, D.F., (2005). Lessons from controversy: ovarian cancer screening and serum proteomics. Journal of the National Cancer Institute, 97 (4), 315-319.
Society of Gynecologic Oncologists. (2004, February). Statement regarding OvaSure™. Retrieved April 14, 2009 from www.sgo.org/WorkArea/downloadasset.aspx?id=1754.
Society of Gynecologic Oncologists. (2008, July ). Statement regarding OvaCheck™. Retrieved November 16, 2004 from http://www.sgo.org/WorkArea/showcontent.aspx?id=954.
Vinintin, I., Feng, Z., Longton, G., Ward, D.C., Alvero, A.B., Lai, Y., et al. (2008). Diagnostic markers for early detection of ovarian cancer. Clinical Cancer Research, 14 (4), 1065-1072.
ORIGINAL EFFECTIVE DATE: 8/13/2005
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