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Bill Puts Biomarker Discovery at Heart of Attack on Ovarian Cancer

NEW YORK (GenomeWeb News) – Lawmakers in the US Congress wanting to accelerate genomics research in ovarian cancer may bypass the budgetary constraints of the 2008 fiscal appropriations bill for the National Institutes of Health by funding such an initiative through a bill introduced in both legislative branches.
 
If it passes, the Ovarian Cancer Biomarker Research Act would authorize the creation of a multi-year, $100 million-plus program that would provide funding for the National Cancer Institute to create centers and clinical trial committees to study biomarkers and diagnostics for ovarian cancer.
 
The bill, which was introduced in the US Senate in late January by Sen. Barbara Boxer (D – Calif.) and earlier in the House of Representatives by Rep. Howard Berman (D – Calif.), would authorize $25 million per year over four years, starting in 2009 and lasting until 2012, to fund centers of excellence to discover and validate biomarkers for detection, screening, and risk stratification of ovarian cancer.
 
Under the rules of the Senate, an authorization such as the Ovarian Cancer Biomarker act is different than an appropriation of funds. Although some authorization bills provide direct spending for direct programs, others only authorize or re-authorize spending for proposed or ongoing programs.
 
This law also would authorize $5 million per year to create biomarker clinical trial committees that would include ovarian cancer experts, statistical analysts, patient advocates, government representatives, and other non-voting members. The centers also would focus on clinical and laboratory validation of ovarian cancer biomarkers, assay method standardization, sample preparation, reagents, reproducibility, and other related research.
 
The funding could be used to create centers at existing research programs, or it could back the creation of entirely new centers at institutions not yet focused on ovarian cancer, said Cara Tenenbaum, a policy analyst at the Ovarian Cancer National Alliance.
 
The funding also would go to develop and implement clinical and epidemiological research on how to use biomarkers for ovarian cancer, as well as developing and implementing repositories for new tissue, urine, serum, and other bio-specimens.
 
“There is currently no effective screening test available for ovarian cancer and the disease is difficult to identify because symptoms are easily misdiagnosed. Without an effective screening test, most women who have ovarian cancer are diagnosed too late to be saved,” Senator Boxer stated when she introduced the bill. 
 
According to the OCNA, each year, approximately 20,000 women in the US are diagnosed with ovarian cancer and around 15,000 women die from the disease. The overall five-year relative survival rate for women with ovarian cancer is around 45 percent, an indicator that, as with breast and certain other cancers, treatments are far more effective in cases when the cancer is detected earlier, which may be a major impetus for Congress to ask for more funding for early-stage diagnostics.
 
“A woman's chance of surviving ovarian cancer is considerably greater if she is diagnosed early. When ovarian cancer is diagnosed early, more than 93 percent of women survive longer than five years,” Boxer stated.
 
The legislation is supported by ovarian cancer interest groups including the Society of Gynecologic Oncologists, the American College of Obstetricians and Gynecologists, the Ovarian Cancer National Alliance, and the American College of Surgeons.
 
There are several companies that are either developing or offering genomic or proteomic diagnostics for ovarian cancer, including CS-Keys, NeoClone, Vermillion (formerly Ciphergen), Calibrant Biosystems, and DNAPrint Genomics.
 
The National Cancer Institute, which declined to comment on the status of the bill, spent a total of $95.1 million in fiscal 2006 on ovarian cancer research out of a total budget of $4.7 billion. NCI’s ovarian cancer funding rose from $93.9 million in 2002 and peaked at $99.5 million in 2004. It was not clear how much of that went to fund biomarker research.
 
The NCI has several programs using genomics and proteomics research related to ovarian cancer. The Ovarian Cancer Trial is building a blood sample repository, the Ovarian Cancer Early Detection Program is seeking early detection screening and testing methods for increased risk, and the Cancer Genome Atlas is working toward identifying major genomic changes involved in cancer using genomic analysis technologies.
 
The Department of Defense’s Ovarian Cancer Research Program has steadily received around $10 million annually through 2002 and 2008, and has funded programs involving detection, preclinical therapeutics, and other lines of study.
 
Spending on early stage pathobiology research, under which biomarker studies would be funded, accounted for around 10 percent of the DoD’s spending on cancer research between 1996 and 2006, according to Gail Whitehead, a spokeswoman for the DoD’s Congressionally Directed Medical Research Programs.
 
Whitehead told GenomeWeb Daily News that grants for early-stage cancer research are highly competitive, in part because it is an area that has made up a small part of the DoD’s budget for cancer studies. “Because it is an underfunded area, perhaps the advocacy groups would like more funds directed in this way,” Whitehead said.
 
The Ovarian Cancer National Alliance is one of those groups. OCNA has asked for boosted funding in 2009, including $25 million for the DoD program, and for increased funding for the NCI, which would allow expanded research programs.
 
Cara Tenenbaum, the analyst at OCNA, told GWDN that ovarian cancer research funding “took a real dip” in the years after 2004, when the NIH’s budget began to flatten out after several years of a “doubling” program.
 
“Part of our problem is that because we don’t have very good survival rates for ovarian cancer patients, we don’t have the loud community of survivors out there banging on the doors to make sure people know it is a public health issue,” Tenenbaum explained.
 
Ovarian cancer is a particularly ripe field in which to prove the value of various types of biomarker-based diagnostics, in Tenenbaum’s view. “There is no early detection test that tells women whether or not they have [ovarian cancer],” she said.
 
“There are a lot of false positive tests. And we have the horror stories about women having false negative results,” she added.
 
Tenenbaum also believes that biomarkers could be used in other diagnostics for treatment, for monitoring the disease, in developing therapeutics, and in helping to predict recurrence.
 

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