A recent study has demonstrated the ability of Roche's Cobas human papillomavirus (HPV) test to individually detect the HPV-16 and HPV-18 genotypes, which cause 70 per cent 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 Pap1 test, a cytology category indicating borderline or atypical cells of undetermined significance (ASC-US).
Dr Mark H Stoler, professor and associate director of surgical pathology and cytopathology at the University of Virginia Health System, said: '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,' Stoler added.
Results from the Athena study also demonstrated that the sensitivity of the Cobas HPV test was equivalent to the current standard of HPV 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.
