New York Times Examines New Ovarian Cancer Test

Main Category: Ovarian Cancer
Also Included In: Cancer / Oncology
Article Date: 28 Aug 2008 - 6:00 PST

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The clinical laboratory company LabCorp is offering a new blood test aimed at detecting ovarian cancer at an early and still treatable stage, but the test is being met with concern among many physicians and medical organizations, the New York Times reports. According to the Times, the Society of Gynecologic Oncologists issued a statement saying it did not believe the test, called OvaSure, had been validated enough for routine use. The Times reports that a number of sophisticated diagnostic tests are entering the market and being used as the basis for important treatment decisions. The article also notes that the debut of OvaSure raises the question of whether greater regulation of diagnostic tests is needed. OvaSure was not reviewed by FDA because the agency does not regulate tests developed and performed by a single laboratory. However, FDA in an Aug. 7 letter sent to LabCorp that was posted on the FDA website asked LabCorp for a discussion on OvaSure's test results and research data, saying that the company "is offering a high-risk test that has not received adequate clinical validation and may harm the public health," the Times reports.

The test was developed at Yale University and has been offered by LabCorp since late June. According to the Times, the test measures the level of six proteins in blood samples, some produced from a tumor and others produced by the body's reaction to the tumor. The test then calculates a probability that the woman has ovarian cancer. The test correctly classified 221 of 224 blood samples taken from women with ovarian cancer or from control groups, according to a study published in the February issue of the journal Clinical Cancer Research. The study also found that the test's false positive rate was 0.6% and that 95% of cancers were identified. However, according to Beth Karlan, director of the Women's Cancer Research Institute at Cedars-Sinai Medical Center, there were few samples from women with early stages of the most deadly type of ovarian cancer and, therefore, the samples tested did not adequately represent what might be found in routine screening (New York Times, 8/26).

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