Ovarian Cancer Tests Sales Illegal, FDA Says
Ovarian Cancer Tests Sales Illegal, FDA Says

FDA’s website posted a warning letter on its site, telling the Laboratory Corporation of America that they illegally sale a blood test to detect ovarian cancer. The LabCorp introduced the test in June and this has increased the hopes of women and doctors. The ovarian cancer test can easily detect the cancer from its earlier stages.

Still, the Society of Gynecologic Oncologists stated that the test can be very harmful. It seems that the safety of it hasn’t been proved accordingly to all health standards and can harm women as far as they can also be caused an unnecessary surgery because of doing the test. Even the FDA added that the blood test “may harm the public health.”

OvaSure, the blood test, doesn’t have the agency’s approval to be marketed, according to the letter the FDA sent to LabCorp on September 29. The agency also added that the test has been released at Yale University and not at LabCorp. It seems that not even the materials were from LabCorp.

Eric Lindblom, a spokesman for LabCorp, stated that they are now discussing with the FDA. “Obviously, we are disappointed about receiving the warning letter,” he added in an e-mail. Dr. Gil Mor, the doctor who developed OvaSure at Yale, said that the blood test has been accurate in every study until now.

The Food and Drug Administration has applied the same policy last year, when they banned a colon cancer screening test released by LabCorp, but not made by them.




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