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FDA Approves HPV Test for Primary Cervical Cancer Screening

FDA Approves HPV Test for Primary Cervical Cancer Screening

Roche's HPV test can now be used as a primary screening method for cer...

The US Food and Drug Administration approved an HPV DNA test earlier today to be used as a primary screening method for cervical cancer in women 25 and older.

The test, the cobas HPV Test, can also give insight into a woman’s future risk of cervical cancer.

The test detects DNA from HPV 16 and HPV 18, which together are responsible for about 70% of cervical cancers, as well as 12 other high-risk HPV types.

“Today’s approval offers women and physicians a new option for cervical cancer screening,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a press release. “Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer.”

The trial that led to the approval of the cobas HPV Test, the ATHENA trial, included more than 40,000 women aged 25 and older undergoing routine cervical exams and compared the HPV test to cytology (Pap smear) as a primary screening method for cervical cancer. Patients whose cervical cells were positive for HPV or were positive on cytology underwent a colposcopy and had their cervical tissue biopsied, which was then compared with the screening results. The researchers concluded that the HPV test could detect HPV 16- or 18-positive ­ high-grade cervical intraepithelial neoplasia, with 92% sensitivity compared with a sensitivity of 53.3% for cytology (P < .0001).

In 2011, the FDA approved the cobas HPV Test to be used in conjunction with a Papanicolaou test (Pap smear). Last month, an FDA panel voted 13 to 0 in support of the expanded use of this screening method.

In 2014, the National Cancer Institute estimates that 12,360 new cases of cervical cancer will be diagnosed and 4,020 women will die of the disease. HPV infections are the cause of nearly all cervical cancers. A high-risk HPV infection will go away on its own in most cases, but persistent infections occur in about 10% of women, raising their risk of cancer.

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