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Large Study Validates Roche's HPV Test Can Assess Women at Heightened Risk of Cervical Cancer

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Originally published Feb. 24.

A screening study involving more than 47,000 women proves the ability of Roche's Cobas 4800 HPV test to detect cancer-causing strains of the human papillomavirus and assess which women are at the greatest risk of developing cervical cancer, the company announced.

The Addressing The Need for Advanced HPV Diagnostics study, or ATHENA, published this week in the American Journal of Clinical Pathology, found that Roche's test was comparable to standard techniques in detecting HPV-16 and HPV-18, viral genotypes that cause more than 70 percent of cervical cancers. Additionally, researchers from Roche Molecular Systems, Columbia University, and the University of Virginia, led by UVA's Mark Stoler, reported that one in 10 women, 30 years and older, who tested positive for one or both genotypes by the Cobas HPV test were diagnosed to have cervical pre-cancer, even though their Pap test was normal.

Although there are HPV vaccines, such as Gardasil and Cervarix, that can protect against the particular types of the virus that cause cervical cancer, once someone is infected with HPV there is no way to eradicate it. However, detecting which women are at high risk for getting cervical cancer and perhaps even catching pre-cancerous disease with the help of tests, such as the Cobas HPV test, would allow doctors to monitor these women closely and start treatment earlier.

In the study, researchers recruited 47,208 US women during routine screenings, who received liquid-based cytology and HPV testing. In this population, atypical squamous cells of undetermined significance, or ASC-US, was found in 4.1 percent of the women, or 1,923 out of 47,208 recruited participants. Of these women, 1,578 women underwent colposcopy and had valid results.

In the AJCP paper, researchers wrote that the Cobas HPV test demonstrated performance "comparable" to Qiagen's Hybrid Capture 2 test for detecting cervical intraepithelial neoplasia grade 2 or worse and grade 3 or worse. They also noted that HPV-16/HPV-18+ women had a greater absolute risk of cervical intraepithelial neoplasia grade 2 or worse (24 percent) compared to the pooled population of HPV-positive women (14 percent) and HPV-negative women (0.8 percent).

"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," Paul Brown, head of Roche Molecular Systems, said in a statement.

According to Stoler, the associate director of surgical pathology and cytopathology at the UVA Health System, the findings from ATHENA show that the Cobas HPV test is "a clinically valid tool" that doctors can use to triage patients with an equivocal Pap test, which is a cytology category indicating that patients have "atypical cells of undetermined significance," or ASC-US. This places women at heightened risk for cervical cancer.

"This ability to identify genotype-related risk will also be highly useful if revisions to ASC-US management guidelines are considered," Stoler said.

According to Roche, its test simultaneously detects 12 high-risk HPV types (HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and provides a "pooled result." The test also individually provides HPV genotypes 16 and 18.

The Cobas HPV test has been available in European countries with CE Marking since 2009. The US Food and Drug Administration is reviewing the test under a pre-market approval application, and as such it is currently not available in the US.

The National Cancer Institute estimates there are 12,200 new cases of cervical cancer in the United States annually and 4,210 deaths as a result of the disease. Globally there are 470,000 new cervical cancer cases each year, according to the World Health Organization.

According to Roche, ATHENA data also suggests that its test can detect cervical pre-cancer that is missed by a Pap test alone. This latest paper in AJCP is the first of a series of articles to be published from ATHENA.

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