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    FDA OKs HPV DNA Test for Primary Cervical Cancer Screening
    Roxanne Nelson is a staff journalist for Medscape Oncology. April 24, 2014

    The US Food and Drug Administration (FDA) today approved the cobas HPV Test (Roche Molecular Systems, Inc) for primary cervical cancer screening in women aged 25 years or older. This is the first human papilloma virus (HPV) DNA test approved in the United States that can be used alone to detect high-risk HPV. The test is recommended for first-line screening, and can specifically identify HPV genotypes 16 and 18, which are responsible for about 70% of all cervical cancers. It also concurrently detects 12 other high-risk genotypes (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68).

    The cobas HPV Test received FDA approval in 2011, to be used in conjunction with or as a follow-up to cell cytology, for women aged 30 years and older. It was also approved for use in women aged 21 years and older as a follow-up test if abnormal results were observed with cytology.

    “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. “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,” said Dr. Gutierrez in a statement.

    Based on results of the cobas HPV Test, women who test positive for HPV 16 or HPV 18 should follow-up with a colposcopy, and those testing positive for 1 or more of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy. The FDA recommends that healthcare professionals use the cobas HPV Test results together with other information, such as the patient screening history and risk factors, and current professional guidelines.

    Supportive data for the cobas HPV Test as a primary screening tool for cervical cancer included data from a prospective cohort study of 47,208 women aged 25 years and older who underwent routine cervical exams. Women who had a positive Pap test or whose cervical cells screened positive for HPV, as well as a subset of women whose Pap and HPV tests were both negative, underwent a colposcopy and cervical tissue biopsy. All biopsy results were compared with the Pap and cobas HPV Test results.

    The sensitivity for cervical intraepithelial neoplasia grade 3 or higher (?CIN3) was 58.26% (95% confidence interval [CI], 44.02% – 74.37%) for the cobas HPV Test and 42.63% (95% CI, 31.75% – 55.41%) for the comparator. The risk for ?CIN3 in those who were not referred to colposcopy by the HPV test algorithm (1-negative predictive value) was 0.42% (95% CI, 0.20% – 0.74%), and the risk was 0.59% (95% CI, 0.36% – 0.92%) among those not referred by the comparator.

    Data from this study, which included 3 years of follow-up on women who underwent colposcopy, showed that the cobas HPV Test is safe and effective for the new indication for use.

    As previously reported by Medscape Medical News, the FDA advisory committee unanimously recommended premarketing approval for the test last month, as a primary screening tool. The Microbiology Devices Panel of the Medical Devices Advisory Committee voted 13 to 0 that the DNA test is safe and effective and that the benefits outweigh the risks for this indication.

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