WASHINGTON - Federal health regulators have cleared a genetic test from Roche as the first U.S.-approved alternative to the pap smear, the decades-old mainstay of cervical cancer screening.
The Food and Drug Administration approved Roche's cobas HPV test to detect the human papillomavirus, or HPV, in women 25 and older. HPV causes nearly all cases of cervical cancer. Such DNA-based tests have been used for several years to confirm results from the pap tests. But Thursday's decision means Roche can now market the test as a stand-alone option for cervical cancer screening, without the pap test.
The decision comes despite pushback from a number of women's health groups, who warned regulators that approving the DNA test as an alternative to pap testing could lead to confusion, higher costs and overtreatment.