The FDA Medical Devices Advisory Committee Microbiology Panel has recommended that a viral DNA test that screens for the human papillomavirus (HPV) in women can replace the standard Papanicolaou test (known as the Pap smear) as a first-line primary cervical cancer screening test.
Earlier this month, the advisory committee voted 13 to 0, citing that the newer cobas viral DNA test was both effective and safe for cervical cancer screening.
The cobas test, a qualitative in vitro test that can detect the presence of HPV is manufactured by Roche Molecular Systems, Inc.
The same test was approved by the FDA in 2011—to be used every 3 years in conjunction with a Pap smear for women between the ages of 30 and 65, and to screen for high-risk HPV strains in patients 21 years of age or older who have an abnormal Pap smear.
The new assay works by first amplifying target DNA from a vaginal swab of cervical cells using the polymerase chain reaction and then hybridizing the DNA to detect 14 HPV types in a single test. The cobas test identifies HPV types 16 and 18, which are responsible for most cervical cancer cases, as well as 12 other high-risk types. Women who test positive for HPV 16 and/or 18 would then be referred to undergo a colposcopy while those who are positive for any of the other high-risk types would first undergo a cervical cytology evaluation to determine if a colposcopy was needed.
The FDA committee voted on the proposal by Roche to have the cobas test be used alone as the standard, first-line method of screening for HPV in women 25 years and older.
The FDA takes the advisory committee’s recommendations into consideration but is not bound to follow its recommendations. However, the FDA has generally followed these recommendations.
Some of the members of the advisory committee noted a concern about lowering the age at which women are tested from 30 to 25.
The large ATHENA trial, which compared the DNA test to a cytology test for cervical cancer screening, showed that the DNA 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). The trial enrolled 41,955 women in the United States aged 25 and older. The trial authors concluded that testing with both cytology and high-risk HPV screening had little benefit over high-risk HPV screening alone.
If the FDA approves use of the cobas test as a sole screening method for HPV clinicians would have a choice of whether to use cytology or the newer DNA test for screening.