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FDA Panel Recommends Roche HPV Test for First-Line Screening

NEW YORK (GenomeWeb News) – Roche today said that a US Food and Drug Administration advisory panel has unanimously recommended the firm's cobas HPV test as a first-line, primary screening tool.

The FDA Microbiology Devices Panel of the Medical Devices Advisory Committee recommended first-line use of the test for women 25 years and older to assess their risk of cervical cancer based on the presence of clinically relevant high-risk HPV DNA. According to the firm, if the FDA follows through on the panel's recommendation, the cobas HPV test would be the first HPV test indicated for first-line screening of cervical cancer in the US.

The test provides genotyping information for HPV 16 and 18, which are the highest-risk types, while simultaneously reporting on the 12 other high-risk HPV types. It runs on Roche's cobas 4800 System, an automated molecular diagnostic system that runs PCR-based assays.

Roche noted that human papillomavirus causes more than 99 percent of cervical cancers, and HPV genotypes 16 and 18 cause 70 percent of these cases.

The cobas HPV test was first approved by the FDA in April 2011 for screening patients age 21 and older with abnormal cervical cytology results, as well as for use adjunctively with normal cervical cytology in women ages 30 and over to assess the presence or absence of high-risk HPV genotypes.

The FDA panel recommended first-line use of the test after Roche filed a Premarket Approval Application last June that included information from its ATHENA trial. That study enrolled more than 47,000 women who were screened for cervical disease and found that "a significant number of women would benefit by using the cobas HPV Test as primary screening for cervical cancer."

"Through technological and scientific advancement, we now have a better screening tool for cervical cancer," Roland Diggelmann, COO of Roche Diagnostics, said in a statement. "We look forward to working with the FDA and medical community to support the growing understanding and awareness of the role that HPV plays in cervical disease, and the importance of the cobas HPV Test, which provides the necessary medical benefit to become the first line test in a cervical cancer screening strategy."

The FDA will now consider whether to follow through on its panel's recommendation.