PHOENIX — More than 12,000 women in the United States will be diagnosed with cervical cancer this year. Hundreds more may go undiagnosed because of the widespread use of a screening test that the Food and Drug Administration has not approved for detecting the human papillomavirus, or HPV, which causes nearly all cervical cancers.
Some of the largest national labs have for a decade routinely used test kits that contain a preservative, BD SurePath, that is approved for Pap tests but not HPV testing. The labs continue to use the tests despite an FDA warning June 8 that HPV tests using SurePath can produce false negatives and national guidelines that call for using only FDA-approved tests, an Arizona Republic investigation has found.
The result: Women may be told they are free of HPV when, in fact, they aren’t. Such a misdiagnosis can allow the virus or cancer to become established and more difficult to treat. Read full article.
