The ATHENA HPV trial was a large, prospective clinical trial evaluating the performance of the cobas® HPV test in three relevant populations*: women with ASC-US (Atypical Squamous Cells of Undetermined Significance) cervical cytology (≥21 years), women with normal cervical cytology (≥30 years), and an overall screening population (25+ years) to explore HPV as a first-line test (longitudinal 3 year trial).1, 2, 3, 4 ATHENA, with over 47,000 women enrolled, also set out to evaluate the medical value of testing for pooled hrHPV DNA as well as genotypes HPV 16 and HPV 18 individually.
*Women <25 years (n=4,183) with normal cytology exited the trial.
The cobas® HPV test was clinically validated in ATHENA, the first screening trial for registration that evaluated simultaneous real-time genotyping of 12 pooled hrHPV genotypes plus HPV 16 and HPV 18 individually. The ATHENA trial evaluated the performance of the cobas® HPV test in multiple clinical situations, including primary screening, ASC-US triage and co-testing (HPV and Pap cytology).
ATHENA not only validated the cobas® HPV test as comparable to the current standard of pooled hrHPV testing within the ASC-US population, but the trial also quantified risk of precancer and cervical cancer in HPV 16+ and/or HPV 18+ women who had ASC-US or who had normal cytology.
The ATHENA trial demonstrated that one in four women who are HPV 16 positive will have cervical disease within three years and that nearly 1 in 7 women with normal Pap cytology who were HPV 16 positive actually had high-grade cervical disease that was missed by cytology.
In addition, results from the ATHENA trial included a comparison of a cobas® HPV test screening strategy to alternative strategies using Pap cytology and HPV testing. The comparison showed that a strategy leveraging the ability of the cobas® HPV test to identify women testing positive for HPV 16 or 18, and using cervical cytology (Pap) as a triage, follow-up test, would allow clinicians to detect more disease without referring a significantly greater number of women to unnecessary follow-up. In 2014, based on ATHENA trial data, the U.S. FDA approved for the first time the use of the Roche cobas® HPV test instead of Pap cytology for first-line primary screening in women 25 and older.