Alternative to Pap Test Is Approved by F.D.A.

ANDREW POLLACK, New York Times

APRIL 24, 2014

The Food and Drug Administration on Thursday approved the first alternative to the long-used Pap test as a primary screening method for cervical cancer, in the face of opposition from some women’s groups and health organizations.

The new test, developed by Roche, detects the DNA of the human papilloma virus, which causes almost all cases of cervical cancer, in a sample taken from the cervix. Pap testing involves examining the cervical sample under a microscope to detect abnormalities.

A committee of outside advisers to the F.D.A. unanimously endorsed the Roche test in a meeting last month.

But a coalition of 17 consumer, women’s and health groups opposed the approval, arguing that the new screening method had not been adequately tested and could upend a practice that has successfully prevented cervical cancer for decades.

“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,” the coalition said in a letter to the F.D.A. earlier this month.

The letter was organized by the Cancer Prevention and Treatment Fund, a research and patient education organization, and signed by the American Public Health Association, Consumers Union, the National Organization for Women and the women’s health education group Our Bodies Ourselves, among others.

A separate letter making similar arguments was sent to the agency earlier this week by a group of doctors and professors.

The F.D.A. said, however, that the evidence was sufficient.

“Roche Diagnostics conducted a well-designed study that provided the F.D.A. with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer,” Alberto Gutierrez, the agency official who oversees diagnostic testing, said in a statement.

In a letter he sent on Thursday to the coalition of opponents, Dr. Gutierrez noted that the agency merely decided if a test was safe and effective for its intended use. It is up to medical societies and other organizations to decide whether and how to use the test. The approval does not mandate use of the HPV test, just makes it another option.

The Society of Gynecologic Oncology, in a statement on Thursday, said it and other organizations were developing an interim guidance document on incorporating primary HPV testing into cervical cancer screening.

Although the group said HPV testing “will provide doctors one more tool to use in cervical cancer screening,” it also acknowledged that the “approval has raised a number of questions.” It said that it was “extremely unlikely that doctors will stop using the Pap any time soon.”

Roche’s Cobas HPV test and HPV tests sold by other companies have been used until now as a follow-up test to help resolve ambiguous Pap results, or together with Pap testing as a primary screening tool.

The new approval would allow the HPV test to be used alone as an initial screen for women 25 and older. Pap testing would be used only in certain cases as a follow-up test.

Studies have shown that HPV testing can result in detection of more precancerous lesions than Pap testing.

However, the virus test could also conceivably lead to more false alarms because presence of the virus does not necessarily mean cancer. Most young women get infected with HPV after they become sexually active, though in many cases their immune systems can clear the virus.

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That is why HPV testing has generally not been used until now in women younger than 30. Opponents of the F.D.A.’s action said approval of HPV testing for women as young as 25 could lead to more young women being sent for unnecessary cervical examinations and biopsies, which in some cases can lead to preterm births or other problems.

Roche has said that it got around that problem because its test specifically detected the two types of the virus that account for 70 percent of the cancers.

Under its proposal, a women testing positive for one of those two types would then go for a cervical examination known as colposcopy. If a woman tested negative for genotypes 16 and 18 but positive for one or more of the other 12 types the test can detect, she would then get a Pap test to see if a colposcopy was warranted.

HPV tests generally cost $80 to $100 while Pap testing costs only $20 to $40, according to Diana Zuckerman, president of the Cancer Prevention and Treatment Fund. Roche said that Medicare paid only about $48 for an HPV test and that when all factors were considered, the difference in cost between HPV and Pap testing was not significant. Pap testing, begun about 60 years ago, has led to a sharp decline in cervical cancer in the United States. But there are still about 12,000 new cases and 4,000 deaths a year, according to the American Cancer Society.