FDA panel recommends HPV DNA test as first-line cervical cancer screening

In a unanimous vote, a Food and Drug Administration (FDA) advisory committee has recommended that the agency give premarket approval to a human papillomavirus (HPV) DNA test as first-line screening for cervical cancer.

Manufactured by Roche Molecular Systems, the cobas HPV DNA test was approved by FDA in 2011 for screening of patients aged 21 and older who have abnormal cervical cytology and for use as an adjunct to normal cervical cytology in women aged 30 and over to assess for presence of high-risk HPV genotypes. The assay provides specific genotyping information for HPV 16 and HPV 18 (the highest-risk subtypes) and also a pooled analysis of 12 other high-risk HPV subtypes, using a single sample from a patient. 

The recommendation by the 13-member Microbiology Devices Panel of the Medical Devices Advisory Committee was based on review of 3-year data from the ATHENA study, a registration trial of 47,000 women aged ≥21 years of age. In ATHENA, specimens from the participants were evaluated at four large regional US laboratories, providing a unique opportunity to evaluate the impact of interlaboratory variations on the performance of cervical cytology. The researchers found considerable differences among the laboratories in overall cytological abnormal rates (3.8% to 9.9%) and in sensitivity of cytology to detect cervical intraepithelial neoplasia (CIN) grade 2 or worse (42.0% to 73.0%). In contrast, the positivity rate for high-risk HPV DNA subtypes varied only from 10.9% to 13.4%, and the sensitivity of the HPV DNA testing from 88.2% to 90.1%. These observations suggested that HPV DNA testing without cytology should be considered as the initial method for cervical cancer screening.

The FDA is not bound by the committee’s recommendation but will consider it in a review of the primary screening indication of the cobas HPV DNA test. If the assay receives FDA approval, it would be the first and only HPV DNA test indicated for first-line primary screening of cervical cancer in the United States.  

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