publication date: Sep. 9, 2016

FDA Warns Against Ovarian Cancer Screening

By Laura Brawley

FDA has recommended against the use of ovarian cancer screening tests, regardless of risk level.

In a safety communication published Sept. 7, the agency warned women and their physicians against relying on “unproven” technology. No study published to date has provided reliable evidence that ovarian cancer screening saves lives, the agency said.

“FDA is concerned that women and their physicians may be misled by such claims and rely on inaccurate results to make treatment decisions,” FDA said in a statement. “Available data do not demonstrate that currently available ovarian cancer screening tests are accurate and reliable in screening asymptomatic women for early ovarian cancer.”

FDA’s recommendation echoes previous statements from other organizations. The U.S. Preventive Services Task Force recommends against screening for ovarian cancer: the screening tests received a “D” score.

“The USPSTF concludes that there is at least moderate certainty that the harms of screening for ovarian cancer outweigh the benefits,” the task force wrote.

The American Cancer Society, Memorial Sloan Kettering Cancer Center, and Mayo Clinic recommend against ovarian cancer screening. The CDC recommends patients consult their doctor on whether they should be screened if they have certain risk factors or show symptoms of ovarian cancer.

According to NCI, ovarian cancer is the fifth leading cause of cancer death in women in the United States. Two tests are used to screen for ovarian cancer: transvaginal ultrasound (TVU) and the CA-125 blood test. A manual pelvic exam can also be used to look for ovarian cancer.

“There are no ovarian cancer screening tests that have been cleared or approved by the FDA,” the agency said.

FDA specifically expressed concerns that patients could be misled by … Continue reading 42-33 FDA Warns Against Ovarian Cancer Screening

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