In another win for Roche ($RHHBY), a panel of experts unanimously recommended that the company's HPV test could be used for primary screening of cervical cancer.
The FDA 's Microbiology Devices Panel of the Medical Devices Advisory Committee found that the company's Cobas HPV diagnostic was safe for use in women 25 years and older, and that the benefits of the test outweighed the risks. The panel's recommendation moves Roche one step closer to securing a Premarket Approval (PMA) supplement for Cobas--making it the first test approved by the FDA for frontline screening of cervical cancer, the company said in a statement.
It has been a long road for Roche, which has already secured major regulatory milestones for its HPV test: In 2011, the FDA approved Cobas to screen patients ages 21 and older with abnormal cervical cytology results, and to identify the presence or absence of high-risk HPV genotypes in women ages 30 and older. The test was approved for use in tandem with Pap cytology as part of the cervical cancer screening process.
In June 2013, the Swiss company filed for a submission for a PMA supplement for its diagnostic test. The filing included three-year registry data from Roche's ATHENA study, which screened more than 47,000 women for cervical disease. Results showed that approximately one in 7 women with normal Pap cytology who were HPV 16 positive had high-grade cervical disease that was missed by cytology, the company said in a statement.
"Our ATHENA study validates the value of HPV DNA detection, and we are confident that these data will demonstrate to the FDA that we have established the clinical utility of the Cobas HPV Test in primary screening for physicians and their patients," Paul Brown, Roche's molecular diagnostics head, said in an earlier statement.
While the FDA is not bound to panel recommendations, positive words could bode well for Roche: The agency often takes the panel's advice into consideration when reviewing medical devices, and glowing reviews could speed up the PMA approval process. With an FDA OK for its cobas test, Roche could increase its stateside presence--and add to its 20% share of the global diagnostics market.
"Through technological and scientific advancement, we now have 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," said Roche Diagnostics COO Roland Diggelmann. "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."
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