ATHENA HPV trial overview
A summary of key findings
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.
ATHENA HPV trial unique study design
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
- ASC-US cytology (≥21 years)
- Normal cytology (≥30 years)
- Overall population (≥25 years)
ATHENA HPV trial objectives
Goals in the ASC-US and NILM populations
Objectives in the ASC-US population2
- To evaluate the performance of the cobas® HPV Test (detection of 14 high-risk types for identification of high-grade cervical disease: CIN2, CIN3, cervical cancer, or adenocarcinoma in situ [ACIS])
- To compare the risks of high-grade cervical disease between women with a positive and those with a negative cobas® HPV Test result
Analysis population: Subjects ≥21 years with ASC-US cervical cytology
Objectives in the NILM (women with normal cytology) population1
- Compare the risk of having ≥CIN2 among the following groups of women with normal cytology aged 30 years or more:
- Positive vs. negative cobas® HPV Test result (14 hrHPV genotypes)
- Positive result for HPV genotype 16 and/or 18 vs. negative result for all 14 hrHPV genotypes
- Positive result for HPV genotype 16 and/or 18 vs. positive result for any of the other 12 genotypes
hrHPV: high-risk Human Papilloma Virus
ACIS: Adenocarcinoma in situ
ASC-US: Atypical Squamous Cells of Undetermined Significance
CIN2: Grade 2 Cervical Intraepithelial Neoplasia
CIN3: Grade 3 Cervical Intraepithelial Neoplasia
- cobas® 4800 HPV Test US package insert. April 2011.
- 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.
- 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.
- 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.