The US Food and Drug Administration (FDA) advisory committee unanimously recommended Roche’s cobas HPV (human papillomavirus) test as a first-line primary screening tool in women 25 years and older to assess their risk of cervical cancer based on the presence of clinically relevant high-risk HPV DNA.
If the FDA agrees with its advisory committee and approves the new use of Roche’s test, it would become the first and only HPV test indicated as the first-line primary screen of cervical cancer in the US.
The agency’s Medical Devices Advisory Committee Microbiology Panel unanimously concluded that the cobas HPV test is safe and effective for the proposed indication for use.
According to the panel, the benefits of the cobas HPV test far outweigh the risks associated with it.
Although the FDA is not required to follow the recommendations of its advisory panels, it typically does.
Columbia University Medical Center, New York Professor Emeritus of Pathology and Cell Biology Dr Thomas C Wright Jr said every year, 12,000 women are diagnosed in the US 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," Dr Wright said. "Women need better access to screening tools that include primary HPV screening in order to reduce their risk of developing cervical cancer.
"I am pleased that the FDA panel recognised 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 data the committee reviewed in its decision comes from a trial called ATHENA, which included more than 47,000 women.
ATHENA demonstrated that nearly one in seven women with normal Pap cytology who were HPV 16 positive actually had high-grade cervical disease that was missed by cytology.
Roche Diagnostics COO Division Roland Diggelmann said through technological and scientific advancement, the company now has a better screening tool for 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 said.
In April 2011, the cobas HPV test received FDA approval for use among women aged 21 and older who have already received an abnormal Pap test. It is also approved as an add-on to a standard Pap test in women aged 30 and older.
Based on three-year follow-up data from the ATHENA study, Roche’s landmark US-based registration trial, in June 2013, the company submitted its premarket approval (PMA) supplement for the cervical cancer primary screening indication to the FDA.
According to Roche, the cobas HPV test is able to screen for a variety of high-risk strains of HPV.
The cobas HPV test is the only FDA-approved HPV assay that simultaneously provides pooled results of 12 known high-risk genotypes and individual results on the highest-risk genotypes, HPV 16 and HPV 18, giving three results in just one test.
The system also runs the cobas CT/NG test (chlamydia/gonorrhea), the cobas BRAF V600 mutation test and the cobas EGFR mutation test.
Image: High-grade dysplasia (carcinoma in situ) in the uterine cervix. Photo: courtesy of Haymanj.