Can Ovarian Cancer Test Detect Tumors Early?

FDA says test isn't reliable

A blood test that can identify cancer in its earliest stages, including ovarian cancer, which doesn't have many symptoms, has been taken off the market

"It was a shock," said Christy Schmidt.

She found out 10 years ago that she had late stage 2 ovarian cancer.  She went through treatment and her cancer hasn't come back. 

"I was pretty darn lucky that I didn't wait another three or six months," she said.

She was lucky. A lot luckier than most women who get ovarian cancer.  Usually three-quarters of them don't find out until after the cancer has spread beyond the ovary.

That's because the symptoms of ovarian cancer can be very vague. They include bloating, frequent urination, pelvic pain or maybe no symptoms at all. By the time a woman sees her doctor, it's often too late for cancer treatment to succeed. That's why researchers are trying to get a diagnostic test on the market.

"You want to be able to prevent it if possible, and if that's not possible, you want to be able to find it early, when they're more treatable," said Washington Hospital Center gynecologic oncologist Dr. Jonathan Cosin.

Cosin wants a test for ovarian cancer, but he said there's one big problem with the tests developed so far. They produce too many false positive results. The only way to know for sure if there's cancer is surgery. 

"We're going to have droves of women without ovarian cancer coming into our office needing surgery for a disease, to try and rule out a disease that they actually don't have," he said.

One test, called OvaSure, was recently put on the market. It tests for six different protein markers in the blood. According to the manufacturer's own data, for every 100,000 women with an average risk of ovarian cancer who take the test, about 638 will get positive results, Cosin said. Of those women, only 40 will actually have the disease.

"That's an awful lot of women," Cosin said. "That's 600 women to get surgery, for 38 who actually have the cancer."
D.C. gynecologist Dr. Marilyn Jerome said she has high hopes for OvaSure. She's given the test to about 15 patients. One came up with a false positive.

"We've been waiting for this technology to come out for many years, and when it was finally released, I was very excited," she said. "I became a little disenchanted with it because I wanted better results. So now I'm a little shy of seeing the test until I see more studies."
The test's manufacturer, Lab Corp, stands by its test. But the Food and Drug Administration pulled it off the market a few weeks ago, saying it hadn't been properly approved yet.  The company is working with the FDA to get it back on the market.

"It's a major decision to approve one of these tests, and because of women's health, you really need to be sure about it," said Christy Schmidt.

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