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 ASC-US triage and co-testing.1
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 HPV trial was a large, prospective clinical study evaluating the performance of the cobas® HPV Test in three relevant populations: women with ASC-US cervical cytology, women with normal cervical cytology, and an overall screening population (25+ years) to explore HPV as a first-line test (ongoing longitudinal 3 year study).
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 16 and 18 individually.2
ATHENA sub-populations examined:*2
*Women <25 years (n=4,183) with normal cytology exited the study.
Objectives in the ASC-US population2
Analysis population: Subjects ≥21 years with ASC-US cervical cytology
Objectives in the NILM (women with normal cytology) population1
Analysis population: Subjects ≥30 years with normal cytology
1. cobas® 4800 HPV Test US package insert. April 2016.
2. Stoler MH, Wright TC, Sharma A, et al. High-risk human papillomavirus testing in women with ASC-US cytology: results from the ATHENA HPV study. Am J Clin Pathol. 2011;135(3):468-475.
3. Wright TC Jr, Stoler MH, Sharma A, Zhang G, Behrens CM, Wright TL. Evaluation of HPV-16 and HPV-18 genotyping for the triage of women with high-risk HPV+ cytology-negative results. Am J Clin Pathol. 2011;136:578-586.
4. Castle PE, Stoler MH, Wright TC Jr., Sharma A, Wright TL, Behrens CM. Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening of women aged 25 years and older: a subanalysis of the ATHENA study. Lancet Oncol. 2011;12(9):880–890.