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FDA advisory committee unanimously recommends DNA-based HPV test

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An FDA panel unanimously endorsed the cobas HPV Test as a primary cervical cancer screening tool for women aged 25 years and older.

The FDA Medical Devices Advisory Committee’s Microbiology Devices Panel agreed the benefits of the cobas HPV Test (Roche) outweigh the benefits, and that the test is safe and effective for its proposed indication.

Clinically validated by the 3-year ATHENA trial, which enrolled more than 47,000 women, the cobas HPV Test is the only FDA-approved HPV assay that provides specific genotyping information for HPV 16 and 18, the highest-risk genotypes responsible for 70% of cervical cancer cases. In addition, the test concurrently reports the 12 other high-risk HPV types as a pooled result from a single patient sample.

The cobas test received FDA approval in April 2011 for follow-up screening of patients aged 21 years and older who had abnormal  cervical cytology results, and for use adjunctively with normal cervical cytology in women aged 30 years and older to assess the presence or absence of high-risk HPV genotypes.

Roche submitted their Premarket Approval supplement for the cervical cancer primary screening indication with the FDA in June 2013.

“Every year, 12,000 women are diagnosed in the U.S. with cervical cancer. This is especially tragic because cervical cancer is a largely preventable disease, and it is well established that HPV is the cause of almost all cervical cancers worldwide,” Thomas C. Wright, Jr., MD, professor emeritus of pathology and cell biology at Columbia University Medical Center said in a press release.  “I am pleased that the FDA panel recognized the importance of validated, scientific evidence documenting the use of primary HPV screening to detect women at risk of invasive cervical cancer and allow us to prevent cervical cancer from developing.”

The cobas test still must be approved by the FDA. The FDA often follows the recommendations of its advisory committees but is not required to do so.