The cobas® 4800 HPV Test was clinically validated by the landmark ATHENA trial, the largest-ever U.S.-based registration study for cervical cancer screening. It validated the test for:
ATHENA was the first screening trial for registration to evaluate simultaneous real-time detection of 12 pooled high-risk HPV (hrHPV) genotypes plus HPV 16 and HPV 18 individually.
With over 47,000 women enrolled, ATHENA not only validated the cobas® 4800 HPV Test as comparable to the current standard of pooled hrHPV testing within the ASC-US population, but the trial also quantified the risk of precancer and cervical cancer in women positive for HPV 16 and/or HPV 18 who had ASC-US or normal cytology (NILM). ATHENA was also the first trial designed to validate HPV DNA detection with 16 and 18 genotyping for use as the primary test in cervical cancer screening without cervical cytology.
The cobas® HPV Test’s performance was clinically validated by the landmark ATHENA trial, providing confidence in the test’s clinical reliability, accuracy, and relevance. It is the only FDA-approved test that meets the preferred high-risk HPV (hrHPV) testing options defined in the new U.S. cervical cancer screening guidelines in one single test.1
The cobas® HPV Test improves upon other commercially available HPV tests by providing 3 results in 1 test run (HPV 16, HPV 18 and 12 hrHPV pooled). By providing individual identification of the highest risk HPV genotypes 16 and 18, the test gives clinicians the information they need to identify women at the highest risk of cervical disease.
The cobas® HPV Test supports a safely extended screening interval for women with normal cytology who are HPV negative, similar to other hrHPV DNA tests. In addition, the cobas® HPV Test allows a reduction in the screening burden on physicians and their patients.
1. 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.