Earlier last week you may have heard health advocates advise against a new DNA test, manufactured by Roche, which detects the human papillomavirus. But that’s not why groups have advised against the test. The genetic HPV test has actually been available for a few years now, but Roche has asked the U.S. Food and Drug Administration to approve the test as a Pap smear alternative. As of Thursday, the FDA has approved the request, despite what opponents have to say.
Women who are 25 and older would undergo the HPV DNA test to see if any additional testing is needed to detect cervical cancer. Since 10 percent of women infected with high-risk HPV have a greater chance of developing cervical cancer, an early detection of HPV is crucial for female patients.
“Current guidelines call for regular Pap smears with or without an HPV test, but not for just an HPV test alone,” said President and CEO of National Alliance for Hispanic Health, Dr. Jane Delgado. “Although we think it’s very good that there is now DNA models for looking at HPV, that by itself is not sufficient.”
According to the FDA press release, more than 40,000 women 25 and under who were undergoing routine cervical exams were included in the study for the DNA HPV test. Both women who tested positive and negative for HPV, as well as the Pap exam, also went through a colposcopy and cervical tissue biopsy. Based on the data results, the FDA determined the DNA HPV test is “safe and effective for the new indication to use.”
“What they’re saying is that it’s safe and effective, but they’re not saying whether it’s a substitute for the Pap test,” pointed out Dr. Delgado.
Other advocacy groups also argue that an HPV test by itself wouldn’t be useful because many women have HPV that eventually disappears without any necessary treatment. “Having an HPV test without also getting a Pap smear to check for problems is going to scare a lot of women who are not developing cervical cancer,” said Dr. Diana Zuckerman of the Cancer Prevention and Treatment Fund in a statement.
“[A Pap] tells you whether or not you have any abnormalities, and while some cervical cancer may be due to HPV, that’s not the case of all of them,” said Dr. Delgado.
According to the Centers for Disease Control (CDC) HPV is not only responsible for several cases of cervical cancer, but is also responsible for 50 percent of vulvar cancers, over 60 percent of vaginal cancers, 35 percent of penile cancers, more than 90 percent of anal cancers, as well as 60 percent of oropharyngeal cancers.
However, doctors practice a conjunction of both a Pap test and HPV screening because the Pap smear is used to identify abnormal cells making it a more adequate choice for a first-step exam.
“This is a time where most of health cares influx, and this is why consumers need to be very attentive to their own health,” said Dr. Delgado, “because what is required of both healthcare providers and healthcare consumers is shifting dramatically.”