WASHINGTON (AP) — Federal health regulators have cleared a genetic test from Roche as a first-choice screening option for cervical cancer. It was a role previously reserved for the Pap smear, the decades-old mainstay of women’s health.
The Food and Drug Administration approved Roche’s cobas HPV test to detect the human Papillomavirus, or HPV, in women 25 and up. HPV causes nearly all cases of cervical cancer.
Doctors already use such DNA-based tools as a follow-up to confirm Pap test results. But Thursday’s decision means Roche can now market its test as a first-choice option for cervical cancer screening, ahead of the Pap test.
Currently no major medical guidelines recommend HPV testing alone for cervical cancer screening. Dr. David Chelmow of Virginia Commonwealth University said physicians should hold off on using the test until medical societies can provide guidance on some key questions, including how frequently it should be used. Chelmow spoke on behalf of the American College of Obstetrics and Gynecology at the FDA’s meeting to review the test last month.
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But the FDA approval allows Roche to market its test for women as young as 25. Women who test positive for the most high-risk strains of HPV should be referred for a colposcopy, an invasive test in which doctors view the cervix with a magnifying device and often collect a tissue sample for testing.
Groups including the Cancer Prevention and Treatment Fund, American Medical Women’s Association and Our Bodies Ourselves questioned why the FDA would approve labeling that goes against medical society recommendations.
In its statement approving the test, the FDA staff suggested its decision would not change how doctors use HPV screening.
“It does not change current medical practice guidelines for cervical cancer screening. These guidelines are developed, reviewed and modified by groups other than the FDA,” said Dr. Alberto Gutierrez, who oversees the FDA’s medical testing office.
But patient advocates rejected that reasoning.
“They imply that the FDA approval decision isn’t that important in deciding how this test will be used,” said Diana Zuckerman, president of the Cancer Prevention and Treatment Fund. “By claiming to pass the buck to the experts in the field, FDA is not taking responsibility for the agency’s influential decision to approve the test as a replacement of the Pap smear for women over 25.”
Switzerland-based Roche said in a statement that the FDA approval “is recognition for the value the cobas HPV test provides to physicians and women to make more informed decisions.”
Article also appears in NBC News and the St. Louis Post-Dispatch.