Relationships | 08/26/2008 12:00 pm
New Ovarian Cancer Test May Increase Survival Rate

Women and their physicians are hopeful about a new blood test aimed at detecting ovarian cancer at an early stage, but some experts and government officials aren’t quite so sure.
The test is called OvaSure and was first offered in late June. The New York Times reports that with only about 20 percent of ovarian cancer cases detected early, there is a great need for an early warning procedure. If the disease is detected early, statistics show more than 90 percent of early-diagnosed women will live at least five years.
The Ovarian Cancer National Alliance — which urges women to wait for more data before relying on the test — says this year more than 21,000 women will be diagnosed with ovarian cancer, and more than 15,000 women will die of the disease. Fewer than 20 percent of women are diagnosed in Stage I, when the chance of survival is greatest.
Despite prospects for the test, some groups are hesitant, saying it hasn’t been validated enough for routine use.
"You’ve got industry trying to capitalize on fear," Dr. Andrew Berchuck, director of gynecologic oncology at Duke University and former president of the the Society of Gynecologic Oncologists, told the Times. "We’d all love to see a screening test for ovarian cancer … but OvaSure is very premature."
The FDA is now saying that LabCorp, a clinical lab offering OvaSure, needs to show more support for the data backing the company’s claims about the test.
"We believe you are offering a high-risk test that has not received adequate clinical validation and may harm the public health," the agency said in an August 7 letter sent to LabCorp.
LabCorp officials say OvaSure has been validated in several studies and that additional data were expected by the end of this year. The biggest concern from critics of the test is not that it will miss cancers but that it will say a cancer is there when it is not, thereby subjecting women to needless surgery to have ovaries removed.























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