Pap Test Alternative Gets FDA Approval
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.
Image: Pap smear test, via Shutterstock