FDA Advisory Committee Unanimously Recommends HPV Test as Primary Screening Tool for Detection of Women at High Risk for Cervical Cancer
The U.S. Food and Drug Administration (FDA) Microbiology Devices Panel of the Medical Devices Advisory Committee has recommended unanimously that the benefits of the cobas human papillomavirus (HPV) test outweigh the risks as a first-line primary screening tool to assess the risk of cervical cancer in women 25 years and older. The panel also voted unanimously that the test is safe and effective for the proposed indication for use. If approved, the test would become the first HPV test indicated as the first-line primary screen of cervical cancer in the United States.
Cobas is an HPV assay that assesses the risk of cervical cancer based on the presence of clinically relevant high-risk HPV DNA. The test 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 from one patient sample.
ATHENA Study
The ATHENA study, which included more than 47,000 women, showed that a significant number of women would benefit by using the cobas HPV test as primary screening for cervical cancer. In the study, 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.
"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. Women need better access to screening tools that include primary HPV screening in order to reduce their risk of developing cervical cancer," said Thomas C. Wright, Jr, MD, Professor Emeritus of Pathology and Cell Biology, Columbia University Medical Center, New York.
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.
The cobas HPV test received FDA approval in April 2011 for screening patients aged 21 and older with abnormal cervical cytology results and for use adjunctively with normal cervical cytology in women aged 30 and over to assess the presence or absence of high-risk HPV genotypes.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
