110th Congress

Ovarian Cancer Biomarker Act

H.R. 3689/S. 2569

Background

Ovarian cancer is a cancer that forms in the tissues of the ovary. Most ovarian cancers are either ovarian epithelial carcinomas (cancer that begins in the cells on the surface of the ovary) or malignant germ cell tumors (cancer that begins in egg cells).

The National Cancer Institute (NCI) supports a broad portfolio of research in this area, including the search for biomarkers to screen for ovarian cancer and find it at an earlier, more curable stage. A cancer biomarker is a substance in the body that—by its presence, pattern, or behavior—alerts clinicians to hidden biologic activity that may be associated with some aspect of the precancerous or neoplastic process. One example of a biomarker is a blood protein called CA-125 (or cancer antigen 125), which is often released when cells are inflamed or damaged. Increased levels of CA-125 can be a sign of cancer; however, this is not an ideal screening test for ovarian cancer because the test results in many false positives. In order to find more biomarkers for ovarian and other types of cancers, biorepositories are needed. Biorepositories are collections of tissue (e.g., tumor cells), biological fluids (e.g., blood), and associated data (e.g., medical records) used by biomedical researchers in a variety of settings, such as a cancer center or doctor’s office.

Examples of current NCI-supported activities focused on the development of ovarian cancer biomarkers and biorepositories include the following:

• The Early Detection Research Network (EDRN) focuses on bringing novel cancer biomarkers from the laboratory to the clinic through a multidisciplinary, nationwide cooperative infrastructure along with standard operating procedures for the concerted and systematic clinical evaluation and validation of prospective biomarkers. EDRN investigators are currently testing the potential of more than 70 prospective biomarkers to detect early-stage ovarian cancer before the development of symptomatic disease.
• NCI supports five Specialized Programs in Research Excellence (SPOREs) in ovarian cancer. Each SPORE maintains a tissue bank, and most will provide samples to outside investigators following scientific review. In addition, EDRN investigators, in collaboration with NCI’s SPOREs in ovarian cancer, are performing head-to-head comparisons of several promising serum biomarkers that have demonstrated strong predictive value in early-stage ovarian cancer.
• The Cooperative Human Tissue Network (CHTN) collects a variety of biospecimens prospectively based on the requests and specifications of researchers. Between 2002 and 2006, CHTN collected an average of 2,200 ovarian specimens per year for a total of 11,083 samples collected during that time period.
• The Gynecologic Oncology Group (GOG), which includes more than 50 principal centers, provides biospecimens to both GOG investigators and outside investigators.

Provisions of the Legislation/Impact on NIH

The Director of NCI, in consultation with the directors of other relevant National Institutes of Health Institutes and Centers and the U.S. Department of Defense Ovarian Cancer Research Program, would be required to make awards to establish and operate Ovarian Cancer Biomarker Centers of Excellence to conduct research on biomarkers for use in risk stratification for and the early detection and screening of ovarian cancer, including fallopian tube cancer and primary peritoneal cancer. NCI would be required to make the first award within 1 year of enactment and provide an annual report to Congress on these awards. Banked serum and tissue specimens funded by these awards would be required to be made available for research. The bill would authorize research on the following:

• Development and characterization of new biomarkers and refinement of existing biomarkers for ovarian cancer
• Clinical and laboratory validation of such biomarkers, including technical development, standardization of assay methods, sample preparation, reagents, reproducibility, portability, and other refinements
• Development and implementation of clinical and epidemiological research on the use of biomarkers for the early detection of and screening for ovarian cancer
• Development and implementation of repositories for new tissue, urine, serum, and other biological specimens (such as ascites and pleural fluids)

The legislation would authorize $25 million to be appropriated for each of the fiscal years (FYs) 2009 through 2012 and such sums as may be necessary for each of the FYs 2013 through 2019 to carry out this mandate.

The Director of NCI would be required to establish an Ovarian Cancer Biomarker Clinical Trial Committee to assist in designing and implementing one or more national clinical trials to determine the utility of using biomarkers validated through research conducted through the Ovarian Cancer Biomarker Centers of Excellence. S. 2569 specifies that the Committee must be established and operated in consultation with GOG.

In designing and implementing the clinical trials, the Director of NCI would be required to provide for the following:

• To the greatest extent possible, all academic centers, community cancer centers, and individual physician investigators must have the opportunity to participate in the trials and enroll women at risk for ovarian cancer.
• Subject to the availability of appropriations, all the costs to the centers and offices described above for enrolling women in the trials under this section must be reimbursed by NCI.
• A national data center to conduct statistical analyses of the data derived from the trials under this section and store such analyses and data must be established and supported by NCI.
• Data and statistical analyses of the clinical trials must be used to establish clinical guidelines to provide the medical community with information regarding the use of biomarkers validated through research conducted by the Ovarian Cancer Biomarker Centers of Excellence.

The Director of NCI would be required to submit an annual report to Congress on the activities of the Ovarian Cancer Biomarker Clinical Trial Committee. The legislation would authorize $5 million to be appropriated for each of the FYs 2009 through 2012 and such sums as may be necessary for each of the FYs 2013 through 2019 to carry out this section.

Status and Outlook

H.R. 3689 was introduced by Howard L. Berman (D-CA) on September 27, 2007, and was referred to the House Committee on Energy and Commerce. No further action has occurred on this legislation.

S. 2569 was introduced by Senator Barbara Boxer (D-CA) on January 29, 2008, and was referred to the Senate Committee on Health, Education, Labor and Pensions. No further action has occurred on this legislation.

March 11, 2008