The FDA's Medical Devices Advisory Committee Microbiology Panel has agreed unanimously (13-0) that the cobas® viral DNA test for human papillomavirus (HPV) made by Roche Molecular Systems is safe and effective for cervical cancer screening. Furthermore, the panel recommends that the HPV test replace the Pap smear as the first-line standard of care for cancer screening. Based on studies, the panel concluded the DNA test was more effective in detecting women with disease and required fewer women without disease to go to colposcopy. Committee members were not concerned about losing other diagnostic benefits of the Pap Smear (such as diagnosing trichomonas and abnormal endometrial cells) because there are other more effective ways of diagnosing these diseases.
[1] Medical Devices Advisory Committee Microbiology Panel Meeting: Sponsor Executive Summary: cobas® HPV Test - Panel Track P100020/S008 (January 31, 2014), retrieved from FDA.gov.
[2] Frieden, Joyce "FDA Panel: Roche's DNA Test Can Replace Pap Smear", MedPage Today (March 12, 2014).
[1] Medical Devices Advisory Committee Microbiology Panel Meeting: Sponsor Executive Summary: cobas® HPV Test - Panel Track P100020/S008 (January 31, 2014), retrieved from FDA.gov.
[2] Frieden, Joyce "FDA Panel: Roche's DNA Test Can Replace Pap Smear", MedPage Today (March 12, 2014).
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