Roche has announced that the U.S. Food and Drug Administration (FDA) Microbiology Devices Panel of the Medical Devices Advisory Committee recommended unanimously that the benefits of the 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 outweigh the risks. 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 United States.
HPV causes more than 99% of cervical cancers, and HPV genotypes 16 and 18 cause 70% of these cases worldwide. For decades, women have relied on cytology to detect evidence of disease. 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 fact, ATHENA demonstrated that nearly 1 in 7 women with normal Pap cytology who were HPV 16-positive actually had high-grade cervical disease that was missed by cytology.
Roland Diggelmann, COO Division Roche Diagnostics, says “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.”
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. Learn more about the cobas family of products.
