Last week, the FDA rocked the sexual and reproductive health world when it approved a new tool to be used in cervical cancer screening. The test, made by Roche Diagnostics, is a primary HPV test that detects the presence of the virus’ DNA in a cervical sample. This differs from a Pap smear which looks for abnormal, potentially cancerous cells.
Primary HPV testing is not actually a new tool. It has been used for years both as a follow-up test to resolve ambiguous Pap results and together with Pap smears as a primary screening tool in women over the age of 30. The FDA ruling allows it to now be used alone in women 25 years and older for primary screening. If it were to detect either HPV types 16 or 18, the two strains causing the majority of cervical cancers, patients would then be sent for a cervical biopsy. If, however, it detected any of the other strains, they would go for a Pap smear as a follow-up.
Proponents of the test, including the Society of Gynecologic Oncology (SGO), argue that this ruling simply offers health care providers another tool. They point to the fact that it is not completely replacing the tried-and-true Pap smear, but rather adding nuance to cervical cancer screening.
Some consumer groups and professional organizations, however, are worried about the impact of this ruling. There are concerns that this may turn into another PSA-screening debacle where large numbers of patients receive medical care—either additional screening procedures or cancer treatment—that do more harm than good. Simply having HPV does not automatically mean that a woman will develop cervical cancer. HPV infections are incredibly common—almost every sexually active individual will have the infection at some point—and usually cleared by the immune system. If the Roche test detects HPV, a patient will be referred for additional procedures that may be invasive, expensive, and ultimately unnecessary.
Those in favor of using the test for screening emphasize its potential to increase detection of precancerous and cancerous cells. It’s estimated that HPV causes 90% of cervical cancers. But only screening for the virus instead of looking for cancerous cells could delay diagnosis and treatment for the minority of patients in whom cancer of the cervix is not associated with HPV. Finally, the validity of the study used by Roche to test the product is being questioned. As the Patient, Consumer, and Public Health Coalition writes:
“The basis for approval of this indication is a flawed clinical trial. Flaws include the design of the comparator arm, participant age and HPV vaccination status, trial duration, and testing interval.”
For now, the Pap will remain the go-to test while medical societies and organizations like the SGO and the American College of Obstetricians and Gynecologists (ACOG) develop best practice standards for the use of the Roche test.
Other Sexual Health News This Week
Tennessee: Governor Signs Bill Targeting Drug Use During Pregnancy (New York Times)
White House Issues Report on Steps to Prevent Sexual Assault on College Campuses including a new PSA. (Washington Post)