Widely Used HPV Test Produces False-Negative Results, Investigation Finds

January 15, 2013 — Each year, hundreds of women might not be informed of their risk for cervical cancer because of the widespread use of a screening test that is not approved by FDA for detecting the human papillomavirus, according to an Arizona Republic investigation, the Arizona Republic/USA Today reports. HPV causes nearly all cervical cancers.

For a decade, some of the largest national labs have inappropriately used the BD SurePath Pap test to screen women for HPV. A recent study by Johns Hopkins University School of Medicine researchers examined data on more than 17,000 women who were tested for HPV using SurePath. Out of the eight women who were found to have cancer, six had received at least one negative HPV test in the prior two and a half years, the study found.

SurePath likely accounts for one-third of the nation's HPV tests, according to market analyst Michael Farmer. Although federal data are limited on HPV testing and SurePath's rate of false-negative HPV tests, extrapolating the findings of the Johns Hopkins study suggests that 1,000 or more women tested each year using SurePath might be incorrectly informed that they do not have the virus, according to the Republic investigation.

Meanwhile, new cervical cancer screening guidelines from the U.S. Preventive Services Task Force might exacerbate the problem because they call for less-frequent screenings, according to doctors involved in creating the recommendations.

FDA, Manufacturers Aware of False Negatives

Labs have continued to use the SurePath Pap test despite an FDA warning that it produced false negatives. The test's manufacturers attempted and failed at least three times in the last 10 years to gain FDA approval for HPV testing, according to the Arizona Republic/USA Today.

Last June, FDA and Becton Dickinson -- the test's manufacturer -- issued a bulletin solely to labs stating that SurePath is not approved by FDA and "may under certain conditions produce false-negative results ... (that) could lead to inappropriate patient management and potentially compromise patient safety."

However, nearly all of the gynecologists contacted for the Republic investigation were unaware of the bulletin or the issue with SurePath. Kathleen Fry, a former gynecologist in Arizona, said, "Those of us out here in the trenches have no idea; we just use whatever the lab gives us" (Ortega, Arizona Republic/USA Today, 1/14).