April 25, 2014 — FDA on Thursday approved the first alternative to the Pap test as a primary screening method for cervical cancer, despite opposition from some medical, consumer and women's groups, the New York Times reports.
The newly approved test, manufactured by Roche and called the Cobas HPV test, screens cervical samples for the presence of the human papillomavirus, which causes the majority of cervical cancer cases. By comparison, the Pap test involves examining a cervical sample under a microscope to look for abnormalities (Pollack, New York Times, 4/24).
FDA approved the Cobas test in 2011 for use in conjunction with the Pap test (Burton, Wall Street Journal, 4/24).
The latest approval permits Roche to market Cobas for use on its own as a primary screening method for women ages 25 and older. Under this screening method, Pap tests would only be necessary in certain cases as a follow up (New York Times, 4/24).
FDA officials said in a statement Thursday that they approved the method because the company "conducted a well-designed study" involving more than 47,000 women who were screened for cervical cancer using either the Cobas or Pap tests, providing "reasonable assurance of the [test's] safety and effectiveness." The study compared the test results with a biopsy to check for accuracy (Perrone, AP/Washington Post, 4/24).
A committee of outside FDA advisers also supported the Cobas test last month.
Groups Raise Concerns
Some groups have expressed concern that using Cobas as a primary screening method could lead to more false-positives and unnecessary follow-up procedures, such as biopsies.
Earlier this month, a coalition of 17 consumer, women's and health organizations in a letter to FDA opposed Cobas' approval as a primary screening method. They said the method has not been sufficiently tested and could deter the use of Pap tests, which have been used successfully for decades. They wrote, "This proposed indication for the HPV test would represent an unprecedented and significant shift in clinical practice that would affect millions of women for the majority of their adult lives."
A separate letter from a group of health care providers and educators this week also encouraged FDA to reject Roche's approval request.
However, in a letter sent to the groups on Thursday, FDA's Alberto Gutierrez -- who oversees diagnostic testing -- noted that the agency has only decided that the test is safe and effective and that it is up to the medical community to decide if and when to use it.
Meanwhile, the Society of Gynecologic Oncology said in a statement that it and other organizations are creating interim guidelines on incorporating Cobas into cervical cancer screening. While it noted that the test "will provide doctors one more tool to use in cervical cancer screening," it also said that FDA's "approval has raised a number of questions" and that it is "extremely unlikely that doctors will stop using the Pap any time soon" (New York Times, 4/24).