A study published online today in the American Journal of Clinical Pathology demonstrated the ability of cobas 4800 HPV Test (Roche Molecular Systems, Pleasanton, CA) to individually detect HPV-16 and HPV-18, two of the highest risk HPV genotypes causing 70% of cervical cancer cases. The ATHENA (Addressing THE Need for Advanced HPV Diagnostics) study, which involved more than 47,000 women, validates the cobas HPV Test for triage of patients with an equivocal Pap test, a cytology category indicating atypical cells of undetermined significance (ASC-US). This is the first in a series of papers to be published from the ATHENA study.
Persistent infection with human papillomavirus is the principal cause of cervical cancer in women, with HPV implicated in greater than 99% of cervical cancers worldwide. Of the more than 118 different types of HPV, 13-16 types are currently considered high-risk for the development of cervical cancer and its precursor lesions. HPV types 16 and 18 have been identified as the highest risk genotypes. Nucleic acid (DNA) testing is a sensitive and non-invasive method for determining the presence of HPV infection.
According to the National Cancer Institute, there are 12,200 new cases of cervical cancer in the United States and 4,210 deaths due to the disease. The World Health Organization (WHO) estimates there are 470,000 new cases of cervical cancer annually.
“At least four out-of five women in the U.S. will have been infected with HPV at some point in their lives, and it’s critical to have early and accurate information about which individuals are at greatest risk for possible progression to cervical cancer,” said Mark H. Stoler, MD, Professor and Associate Director of Surgical Pathology and Cytopathology, at the University of Virginia Health System. “Results from ATHENA demonstrated that the cobas HPV Test is a clinically valid tool for physicians needing to manage the ASC-US population as it identifies not only high-risk HPV, but also HPV-16/HPV-18 without additional tests. This ability to identify genotype-related risk will also be highly useful if revisions to ASC-US management guidelines are considered,” concluded Dr. Stoler.
Results from the ATHENA study also demonstrated that the sensitivity of the cobas HPV Test was equivalent to the current standard of testing, while providing the added benefit of clinically valuable information regarding the HPV-16 and HPV-18 genotypes in a single test. Previously presented ATHENA data confirmed that the cobas HPV test detected cervical pre-cancer missed by the Pap test, underscoring the limitations of cervical cancer screening with the Pap test alone.
“Arming more clinicians with HPV testing that has HPV-16 and HPV-18 genotyping will bring us one step closer to eradicating cervical cancer,” said Paul Brown, Head of Roche Molecular Systems. “Results of the ATHENA study underscore the potential for a state-of-the-art diagnostic test to specifically identify women at highest risk for cervical disease.”
Roche launched the cobas HPV Test in countries that accept CE Mark in 2009. The test is currently under review and pending Pre-Market Approval (PMA) by the U.S. Food and Drug Administration (FDA). The test is not currently available in the United States.
For more information:
Stoler MH, Wright TC, Sharma A, Apple R, Gutekunst K, et el. High-Risk Human Papillomavirus Testing in Women With ASC-US Cytology Results From the ATHENA HPV Study.American Journal of Clinical Pathology 2011, 135, 468-475.