The Pap test, a mainstay of cervical cancer prevention for 60 years, may be taking a backseat to a new way to screen for the disease.
A federal advisory committee recommended unanimously that a DNA test developed by Roche be approved for use as a primary screening tool for cervical cancer.
"Has our Pap, as we know it, outlived its time?" Dorothy Rosenthal, M.D., a professor at Johns Hopkins University, told The New York Times
In testimony to the committee, which advises the Food and Drug Administration, Dr. Rosenthal said deaths from cervical cancer in the United States had stopped declining and that there would be "a tremendous gain" by moving to the new test.
The Roche test detects the DNA of human papillomavirus (HPV), which causes almost all cases of cervical cancer. Pap testing involves examining a cervical sample under the microscope looking for abnormalities. HPV testing has is now used mainly as a follow-up test when the Pap results are ambiguous.
The 13-to-0 vote by the committee — comprised of academic pathologists, microbiologists, and gynecologists — would allow Roche’s test to be used alone as the initial test for women 25 and older.
If the Food and Drug Administration goes along with its advisory committee recommendation, the DNA test would become just another option, not a replacement for the older testing regimens. And many doctors will not adopt the new test unless professional societies recommend it in guidelines, which could take years.
But its use as a primary screening tool could mean much wider sales of HPV tests. The United States market for such tests is more than $200 million, according to DeciBio, a market research firm.
Current United States guidelines recommend that women 30 to 65 undergo either co-testing with both HPV and Pap every five years, or Pap testing alone every three years. Women 21 to 30 should have Pap testing every three years.
The American Cancer Society estimates that about 12,360 new cases of invasive cervical cancer are diagnosed each year and about 4,020 women die from the disease. Between 1955 and 1992, the cervical cancer death rate declined by almost 70 percent, mainly because of Pap testing. The death rate has remained stable in recent years.
HPV screening is much more sensitive than the Pap test in detecting precancerous lesions.