The panel also voted unanimously that the cobas HPV test is safe and effective for the proposed indication for use. If approved, the cobas HPV test would become the first and only HPV test indicated as the first-line primary screen of cervical cancer in the US.
Roche Diagnostics division COO Roland Diggelmann noted through technological and scientific advancement, the company now has a better screening tool for cervical cancer.
"Women around the world deserve the best tool to know their risk and reduce their chances of developing cervical cancer.
"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," Diggelmann added.
The committee’s recommendation will be considered by the FDA in its review of the primary screening indication for the cobas HPV test. The FDA is not bound by the committee’s guidance, but takes its advice into consideration when reviewing medical devices.
Clinically validated by the landmark ATHENA trial, the cobas HPV test is the only FDA-approved HPV assay that provides specific genotyping information for HPV 16 and 18, the highest-risk types, while simultaneously reporting the 12 other high-risk HPV types as a pooled result, all in one run, from one patient sample.
The cobas HPV test received FDA approval in April 2011 for screening patients age 21 and older with abnormal cervical cytology results and for use adjunctively with normal cervical cytology in women ages 30 and over to assess the presence or absence of high-risk HPV genotypes.
Roche submitted its premarket approval supplement for the cervical cancer primary screening indication with the FDA in June 2013. The filing includes three-year follow-up data from the ATHENA study, Roche’s landmark US-based registration trial. ATHENA enrolled more than 47,000 women who were screened for cervical disease and an impact analysis of screening algorithms was performed based on these data.
The test is performed on the cobas 4800 system, which offers true walk-away automation of nucleic acid purification, PCR (polymerase chain reaction) set-up and real-time PCR amplification and detection to help laboratories achieve maximum efficiency. The system also runs the cobas CT/NG test (chlamydia/gonorrhea), the cobas BRAF V600 mutation test and the cobas EGFR mutation test.
