Ortega reports that the SB Surepath test is administered to about 3 million women each year. The test has an unacceptably high false-negative rate, perhaps as high as 50%, compared to less than 10% for other tests on market. A false-negative means that a woman with HPV is told she's HPV-free and that she should therefore wait longer before getting tested again.
Ortega began his investigation when a doctor told him about a patient who was found to have cervical cancer after getting two false-negative tests in a row.
Records show that the manufacturer, Becton, Dickinson and Co., has known about the defect for years, but the FDA only warned medical labs about the problem last June. Ortega's investigation found that while labs were clued in, doctors and patients were left in the dark.
Major biomedical labs continue to use Surepath to test for HPV despite the high rate of inaccuracy and even though it is not FDA-approved for this purpose. Their actions are legal because federal laws allow laboratories to use tests such as the SurePath test kit for non-FDA-approved purposes as long as the lab conducts a study establishing that test or device's accuracy. The regulations do not require a minimum accuracy.
"Ortega's report sounds the alarm about a very important public health issue that potentially affects millions of women," said Sidney judge Lindsay Beyerstein, "His work raises pressing questions, not only about this particular test, but about how the FDA and medical device manufacturers communicate risk to doctors and the public."
Bob Ortega is a senior reporter at the Arizona Republic, covering the border. He previously reported for the Wall Street Journal and the Seattle Times, among other publications. He served as a Knight International Journalism Fellow in Paraguay in 1999, and subsequently led media-training projects in Georgia, Ukraine and Belarus for the International Center for Journalists and IREX through 2005. He is the author of "In Sam We Trust: The Untold Story of Sam Walton and Wal-Mart, the World's Most Powerful Retailer," Times Books, 1998.