The cobas® HPV Test was clinically validated by the landmark ATHENA trial, a large, prospective clinical study that evaluated the test’s performance in three relevant populations:*1
This was the first screening trial for registration to evaluate simultaneous real-time genotyping 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® 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 HPV 16+ and/or HPV 18+ women who had ASC-US or who had normal cytology (NILM).
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 FDA-approved to meet 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 provides 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.
Learn more about the medical value of the cobas® HPV Test
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.