FDA Recommends Roche's HPV Test as Primary Screening Tool

The 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.

“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 Dr. Thomas C. Wright, Jr., Professor Emeritus of Pathology and Cell Biology, Columbia University Medical Center, NY. “I am pleased that the FDA panel recognized 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.”

HPV causes more than 99 percent of cervical cancers and HPV genotypes 16 and 18 cause 70 percent 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.

“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 Roland Diggelmann, COO Division Roche Diagnostics. “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.