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FDA Approves DNA Test to Screen for Cervical Cancer


On Thursday, the FDA officially approved another tool to help protect yourself against cervical cancer when it unanimously recommended Roche's cobas HPV test, a new DNA exam, as the first U.S.-approved stand-alone alternative to the pap smear. But don't get excited about giving up the stirrups just yet! You're still going to have to get up close and personal with your doctor at your annual exam.

"From a patient's perspective, nothing changes," says Francis Chang, M.D., an ob-gyn at Good Samaritan Hospital in Los Angeles. Current pap testing includes having your doctor scrape your cervical cells, put them through a machine that weeds out debris, and send them to a pathologist for analyzing. In the case of irregularities, the sample is tested for HPV and you're referred to your doctor for a physical scan of the cervix, called a colposcopy.

The main difference between a traditional pap smear and the new test is that the cobas test will allow your doctor to skip the pathologist—the middle man, if you will—and test immediately for HPV. Currently not every pap smear is tested for HPV. And this is good news: "Many studies have shown that HPV testing is a far better predictor of cancer than simply a pap smear," Chang says.

In addition to simply telling you if you have HPV, the DNA test will also ID the strain of HPV—important information as 70 percent of cancers are caused by two particular subtypes: strains 16 and 18. This process would provide better risk analysis and reduce unnecessary colposcopies.

Cervical cancer is scary stuff, but it is easily tested for and—if caught early enough—it's highly curable, Chang explains. Because this type of cancer grows relatively slowly—it takes about 10 years to go from irregularities to full-blown cancer—screenings are truly life-saving. He points out that in countries where screenings are routine, such as in the U.S., cervical cancer drops to No. 20 on the list of cancers that kill women. In countries that don't regularly screen, cervical cancer is usually the No. 1 killer.

But while the news is exciting, Chang says the real news will be if the American Society for Colposcopy and Cervical Pathology (ASCCP) recommends the test as part of their official guidelines for cancer prevention. And although the test is available now, it's likely most gynecological professionals will wait to see if the ASCCP endorses it before they begin using it. In the meantime, Chang recommends sticking with your current pap schedule as determined by your doctor.


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