Pivotal Study Validates Roche's Cobas(R) HPV Test With HPV-16 And 18 Genotyping For Identifying Women In The UK At Highest Risk For Cervical Cancer

Main Category: Cervical Cancer / HPV Vaccine
Article Date: 01 Apr 2011 - 8:00 PDT


Roche announced today that a recent study published online in the American Journal of Clinical Pathology demonstrated the ability of the cobas® Human Papillomavirus (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 Pap1 test, a cytology category indicating borderline or 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.K. 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 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.

"Arming more clinicians with a HPV test that simultaneously provides high risk pooled results as well as individual HPV-16 and HPV-18 genotyping, will bring us one step closer to eradicating cervical cancer," said Paul Eros, Director of Molecular Diagnostics at Roche. "Results of the ATHENA study underscore the potential for a state-of-the-art diagnostic test to specifically identify women at highest risk of cervical disease."

About the Roche ATHENA Clinical Trial

The Roche ATHENA Clinical Trial for the cobas 4800 HPV test is the largest U.S. based registration study for a diagnostic test of more than 47,000 women. The trial is designed to answer current medical and scientific questions about the importance of testing for high-risk HPV genotypes in cervical cancer screening and to provide clinical information about the specific HPV genotypes that put women at highest risk for developing cervical cancer.

About Human Papillomavirus (HPV) and Cervical Cancer

Cervical cancer causes approximately 1,000 deaths each year in the United Kingdom and is the most common cancer in females under 352. Persistent infection with Human Papillomavirus (HPV) is the principal cause of cervical cancer in women, with HPV implicated in greater than 99 percent of cervical cancers worldwide. Of the more than 118 different types of HPV, 14 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, detected in approximately 70 percent of cervical cancers. Nucleic acid (DNA) testing is a sensitive method for determining the presence of a cervical HPV infection.

About the cobas® 4800 HPV Test and cobas 4800 System

As demonstrated in the ATHENA trial, the Roche cobas® 4800 HPV test is a new generation of HPV testing which simultaneously detects in one pass, 12 high-risk HPV types (HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) as a pooled result, as well as HPV genotypes 16 and 18 individually.

Roche launched the cobas 4800 HPV Test with CE Approval in 2009.

Notes:

1. A Pap smear allows for examination of cells from the cervix to detect abnormalities that could lead to cervical cancer.

2. Source: NHS Cancer Screening Programme. Cervical cancer is the most common cancer in women under 35 in the UK.

3. Genotypes are variations in the genetic code (DNA) of an organism.

Source:
Roche

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