FDA Panel Reports HPV Test could Replace the Pap Smear
The panel of experts at the United States Food and Drug Administration (FDA) has voted unanimously to recommend a newly develop HPV (human papillomavirus) test over the traditional Pap smear. The panel stated that the HPV test could be used as an effective first step in screening patients for cervical cancer.
"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.
He added according to the Wall Street Journal, "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."
After a series of three separate votes, each yielding a 13-0 ruling, the FDA's Medical Devices Advisory Committee Microbiology Panel stated that HPV-DNA test that is being manufactured by Roche Molecular Systems is a safe and effective screening tool for cervical cancer. The HPV test looks for signs of the virus in the patient's DNA. The DNA test is currently approved as a follow up test for women over the age of 21 who have already had an abnormal pap smear. The test can be used as the only form of cervical cancer screening for women aged 25 and older.
Despite the panel's recommendation, the FDA does not have to agree and officially recommend Roche's DNA test as the first line of screening tool. Even if the agency approves the HPV test as a screening method, it would just become another option that doctors and patients could turn to. The Pap smear, which has been around for 60 years, could still be the doctors' first choice regardless of the new HPV test.
"I think women are going to be well served by having more choices, but it's going to be very interesting to watch over the next several years as this rolls out," said Dr. Alan G. Waxman, a professor of obstetrics and gynecology at the University of New Mexico reported by the New York Times.
The guidelines within the U.S. state that women between the ages of 30 and 65 should have either a combination of HPV and Pap screenings every five years or a Pap smear alone every three years. For young women between the ages of 21 and 20, Pap smears are recommended every three years.