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VOL. 124 | NO. 183 | Thursday, September 17, 2009

West Clinic Deploys New Test For Ovarian Cancer

By Tom Wilemon

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The West Clinic is one of 27 sites in the United States using a new blood test to determine whether women with a pelvic mass requiring surgery are at high or low risk for ovarian cancer.

The test will help determine whether the surgery should be performed by a gynecologic oncologist, who specializes in treating cancer. It will also let patients know the likelihood of having cancer before surgery is performed. Until now, that likelihood has been difficult to determine ahead of time.

However, the test, which was cleared for clinical trials Friday by the U.S. Food and Drug Administration, is not intended for screening purposes.

“This is not a screening test; this is not a PAP smear,” said Dr. Joseph Santoso, the principal site investigator at The West Clinic. “We don’t want women to start running to their doctors’ offices and start saying, ‘I want to be screened for ovarian cancer.’ That’s not what the FDA wants us to do.”

The West Clinic has enrolled 96 patients in the clinical trial.

Anti-anxiety measure

The OVA1 test will be marketed by Vermillion Inc., a molecular diagnostics company based in Freemont, Calif. Vermillion developed the test with researchers at Johns Hopkins University in Baltimore. OVA1 uses a blood sample to test for levels of five proteins that change when ovarian cancer is present. The results are rated on a scale of one to 10 as to whether the mass is benign or cancerous.

The FDA cleared the test for clinical trial after reviewing a study of 516 patients. The results indicated that the test identified patients who might benefit from oncology referral.

Cure rates are better when surgeries to remove cancerous pelvic masses are performed by gynecologic oncologists, but until now there has not been a way to determine whether cancer was present prior to the surgery.

“In the United States, approximately 10 percent of American women will undergo surgery for (an) ovarian mass in their lifetime,” Santoso said. “Out of that, approximately 1 percent will develop ovarian cancer. Think of it like nine out of 10 women will undergo surgery with concerns about ovarian cancer but not have cancer.”

The test will not only allow health care providers to make better choices about what procedures should be performed and who should do them, it will also give women information sooner about their health and course of treatment.

“Women will be less anxious,” he said. “Right now, most of these women are very anxious.”

Race to this cure

Ovarian cancer is the most deadly and second-most common type of gynecologic cancer, Santoso said.

“Approximately 21,600 women in the United States are diagnosed with ovarian cancer annually,” he said. “It is the most common cause of death among women with gynecologic cancers. It is a deadly cancer due to the fact that when the cancer is found, it is generally widespread.”

About 14,600 women die of ovarian cancer each year, according ot the American Cancer Society.

Although Vermillion developed the test, it has a business arrangement with New Jersey-based Quest Diagnostics for that company to offer the test in the United States for three years. Quest Diagnostics invested in the development of the test.

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