HealthDay News — The FDA Microbiology Devices Panel of the Medical Devices Advisory Committee unanimously recommended that cobas HPV test (Roche Molecular Systems) could replace the Pap test as the first step in cervical cancer screening.
In addition to deciding that the benefits of using the HPV test as a first-line screening tool for cervical cancer outweigh the risks, the committee also unanimously voted that it is safe and effective.
Currently, the cobas HPV test is approved for use among women aged 21 years 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 to 65 years. According to Roche, the cobas HPV test is able to screen for a variety of high-risk strains of HPV.
Although the FDA is not required to follow the recommendations of its advisory panels, it typically does.
Roche is looking for the FDA to approve its HPV test as a first-line diagnostic tool. Women who test positive for the two high-risk HPV strains would then be asked to undergo colposcopy. In addition, women who did not have HPV 16 or 18 but had other high-risk types of the virus would then have a Pap test to see if a colposcopy was needed.
The data evaluated by the committee comes from the ATHENA trial, which included more than 47,00 women.
“[The American College of Obstetricians and Gynecologists] strongly supports further improving cervical cancer screening through the introduction of new paradigms such as HPV testing for primary screening,” David Chelmow, MD, of the Virginia Commonwealth University School of Medicine in Richmond and representative of the College, told HealthDay.
“HPV testing as a primary screening method for cervical cancer is very promising, and appears effective for screening for cervical cancer.”