Scientists hunt for ovarian cancer test, FDA approval

By The Associated Press

Published: September 21, 2008

WASHINGTON — Does a test that promises to find ovarian cancer sooner really do so? Could other tests nearing the market prolong survival by getting patients the right care faster?

A race is on for blood tests to better detect this intractable killer, but the Food and Drug Administration is investigating whether to crack down on the first one to sell.

It's a time of both hope and confusion.

First, the question is whether testing giant LabCorp jumped the gun in selling OvaSure as an ovarian cancer screening test before researchers could prove it catches the tumor in an early, treatable stage without falsely alarming too many healthy women. A legal quirk let sales begin without formal FDA approval.

In fact, U.S. and British scientists are just beginning studies specially designed to prove whether signs of ovarian cancer can be measured reliably in blood months, even a year, before a tumor or cyst becomes life-threatening.

"You really need evidence that screening actually saves lives, or at least prolongs survival,” cautioned Dr. Robert Bast Jr., an ovarian biomarker expert at M.D. Anderson Cancer Center.

Although the FDA won't discuss its ongoing research into OvaSure, it is watching the field closely.

"It's not a question of if, it's a question of when the right test will come along with the right credentialing to help improve health care in this important area,” said Dr. Steven Gutman, FDA's diagnostic testing chief.

At the same time, competing companies are seeking FDA approval for a different approach: Blood tests to help identify which women with an ovarian lump or cyst are most likely to have cancer, so they can have their crucial first surgery — the one that diagnoses malignancy — done by a specialist.

Thousands of women get cysts but only an unlucky fraction of cysts turn out to be cancerous. Studies show even advanced patients can live many months longer if that first operation is done by a gynecologic oncologist, who knows where cancer hides and how to remove pelvic lymph nodes, instead of the general surgeon most see today.

"That's a big, big step forward for women because it allows them to get the proper care,” said Dr. Richard Moore of Brown University, who led a study of Fujirebio Diagnostics Inc.'s "triage test” that correctly predicted cancerous cysts more than 90 percent of the time.

Nearly 22,000 U.S. women will be diagnosed with ovarian cancer this year. Most see a doctor for symptoms that strike after the cancer has spread, when long-term survival plummets. More than 15,000 patients die each year.

Women at high risk because of gene mutations are advised to have their ovaries removed. For the general population, the goal is to create a blood test to detect early cancer signs such as molecules that tumor cells shed, or perhaps unusual hormone changes, without many unnecessary surgeries.

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