For decades, the Pap test has been the way to screen women for cervical cancer. While the test is effective, to say women do not like getting pap smears is an understatement. (Guys, just ask!) So, many will greet the FDA approval of an alternative human papillomavirus (HPV) test, which could mean no more pap smears for some, as good news.
The U.S. Food and Drug Administration approved a genetic test from Swiss firm Roche as the first U.S.-approved alternative to the Pap smear for women 25 and older. Using cervical cell samples, the Roche cobas HPV Test detects DNA from 14 high-risk HPV types. The test can be used as the initial screening tool for a health care professional to assess whether a woman needs further testing for cervical cancer.
Genital HPVs are actually over 40 related viruses that, according to the U.S. Centers for Disease Control and Prevention (CDC), are the most common sexually transmitted infections. However, the 14 HPV types labeled as “high-risk” are associated with cervical cancer. Approximately, one in 10 women infected with high-risk HPV will develop a persistent infection, which then puts them at greater risk of cancer. All cervical cancers are caused by HPV; however, two types, HPV 16 and HPV 18, are responsible for about 70 percent of cervical cancers.
As a result, women who test positive for HPV 16 or HPV 18 using the cobas HPV Test should then have a colposcopy, an exam with a device to illuminate and magnify the cervix. Women testing positive for any of the 12 other high-risk HPV types should have a Pap test as a follow up.
Some women’s health groups expressed apprehension to the FDA that the DNA test would lead to higher costs and over treatment. The concern is that HPV-only testing could lead to overtreatment of younger women who carry the virus but have little risk of developing actual cancer. FDA officials reported that they approved the test after Roche conducted a well-designed trial involving more than 47,000 women who had cervical screening using either Pap or HPV screens. Cost is an issue, though. The HPV tests cost between $80 and $100, which is twice the price for the typical Pap screening.
The FDA first approved the cobas test in 2011 for use along with or as a follow-up to a Pap test. The latest approval expands the use of the test to be a primary screening test for cervical cancer. However, the FDA approval will not immediately result in changes in current medical practices or tests offered by individual doctors. The FDA approval is the first step, but now guidelines need to be developed by health associations, physician groups and/or medical insurance plans. The current cervical cancer guidelines from the American Cancer Society recommends Pap smears every three years for women ages 21 to 29, while women age 30 and older should have a Pap test alone every three years or both a Pap test and the HPV test every five years.
The Pap test has had a successful track record. Over the past 30 years, cervical cancer cases in the U.S. have decreased more than 50 percent due to increased Pap screening. Still, approximately 12,000 cervical cancer cases will probably be diagnosed this year resulting in 4,000 deaths. So, while some wish for no more Pap smears, the test along with the new cobas one serve an important purpose.
By Dyanne Weiss