Study demonstrates ability of cobas HPV Test to detect HPV-16, HPV-18 genotypes linked to cervical cancer

ATHENA study shows the cobas HPV Test advances the standard of care by providing valuable information on the risks associated with the genotypes which cause 70 percent of cervical cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that a study published online today in the American Journal of Clinical Pathology demonstrated the ability of the cobas HPV Test to individually detect HPV-16 and HPV-18, two of the highest risk HPV genotypes causing 70 percent 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.

"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."