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.
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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.
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