August 26, 2008 -IR Summary/NYT - A new blood test called OvaSure has recently been developed at Yale by nation’s largest clinical laboratory companies, which claims to detect ovarian cancer at an early. It early detection can help the women; they can be treated and can live longer.
When ovarian cancer is detected at its earliest stage, when it is still confined to the ovaries, more than 90 percent of women will live at least five years, according to the American Cancer Society . But only about 20 percent of cases are detected that early. If the cancer is detected in its latest stages, after it has spread, only about 30 percent of women survive five years.
So far the Food and Drug Administration is concerned, some of their experts say the test has not been proved to work.
But far from greeting the new test with elation, many experts are saying it might do more harm than good, leading women to unnecessary surgeries.
The Society of Gynecologic Oncologists almost immediately issued a statement saying it did not believe the test had been validated enough for routine use.
“You’ve got industry trying to capitalize on fear,” said Dr. Andrew Berchuck, director of gynecologic oncology at Duke University and the immediate past president of the society. “We’d all love to see a screening test for ovarian cancer,” he added, “but OvaSure is very premature.”
OvaSure’s debut also raises questions about whether greater regulation is needed to assure the validity of a trove of sophisticated new diagnostic tests that are entering the market and are being used as the basis for important treatment decisions.
OvaSure did not go through review by the Food and Drug Administration because the agency generally has not regulated tests developed and performed by a single laboratory, as opposed to test kits that are sold to laboratories, hospitals and doctors. (All OvaSure blood samples are sent to LabCorp for analysis.)
But the F.D.A. has now summoned LabCorp to discuss OvaSure, saying the data appear insufficient to back 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 Aug. 7 letter sent to LabCorp that was posted on the F.D.A. Web site.
Patients and advocacy groups seem divided on OvaSure, which costs about $220 to $240. Full