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FDA Approves HPV DNA Test as Pap Smear Alternative for Cervical Cancer Screening


The U.S. Food and Drug Administration (FDA) last week approved Roche Diagnostics' cobas human papillomavirus (HPV DNA test for initial screening for cervical cancer. The test detects high-risk or cancer-causing HPV types including HPV-16 and HPV-18. Women who test positive for high-risk HPV can then undergo further testing for pre-cancerous or malignant cell changes.

HPV can trigger excessive cell growth resulting in warts or cancer, including cervical and anal cancer. The traditional standard of care for cervical cancer screening is a Pap cytology test, which looks for cell abnormalities -- dysplasia or neoplasia -- that could progress to, or already indicate, cervical carcinoma. Women with abnormal cells should then undergo 

colposcopy, or examination of the cervix with a lighted magnifying instrument. With the new test, women who test positive for HPV-16 or HPV-18 should be offered a colposcopy, while those with one of the other high-risk types should still receive a Pap test as an intermediate step.

The HPV DNA test detects high-risk virus but does not directly indicate abnormal cell growth; most people with HPV infection do not develop dysplasia or cancer. Critics fear that the new test could lead to more false-positive results leading to unnecessary colposcopies and biopsies. A coalition of 17 consumer, women's, and public health organizations opposed the approval, arguing that it could replace Pap tests, which have been used successfully since the 1950s and dramatically reduced the incidence of cervical cancer. However, the ATHENA trial, which included more than 47,000 women, showed that 10% of participants who tested positive for HPV 16 or 18 using the cobas HPV Test had pre-cancerous cell changes even though they had normal Pap tests.

The FDA stressed that approval of the primary HPV DNA test does not change clinical practice guidelines, which are developed by other groups.

"Primary HPV testing does not replace the Pap test, and it is extremely unlikely that doctors will stop using the Pap any time soon," the Society of Gynecologic Oncology (SGO) stated in a press release responding to the approval. "FDA approval of primary HPV testing means the HPV test can be used first when screening a woman for cervical cancer. The two tests screen for cervical cancer in different ways. The HPV test detects the presence of the HPV types responsible for most cervical cancer, and can help identify women at high risk for developing cervical cancer. The Pap test finds pre-cancer and cancer. Having more options for using each of these tests gives doctors more flexibility in choosing the best screening strategy for each individual patient."

SGO indicated that it and other organizations are developing interim guidance to help health care providers determine how to best incorporate primary HPV testing into cervical cancer screening.

Below is an edited excerpt from an FDA press release describing the new test and its approval  in more detail.

FDA Approves First Human Papillomavirus Test for Primary Cervical Cancer Screening

The U.S. Food and Drug Administration today approved the first FDA-approved HPV DNA test for women 25 and older that can be used alone to help a health care professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can provide information about the patient’s risk for developing cervical cancer in the future.

Using a sample of cervical cells, the cobas HPV Test detects DNA from 14 high-risk HPV types. The test specifically identifies HPV 16 and HPV 18, while concurrently detecting 12 other types of high-risk HPVs. 

Based on results of the cobas HPV Test, women who test positive for HPV 16 or HPV 18 should have a colposcopy, an exam using a device that illuminates and magnifies the cervix so a physician can directly observe the cervical cells. Women testing positive for one or more of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy. Health care professionals should use the cobas HPV Test results together with other information, such as the patient screening history and risk factors, and current professional guidelines.  

"Today’s approval offers women and physicians a new option for cervical cancer screening," said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. "Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer."

The FDA first approved the test, called the cobas HPV Test, in 2011 for use in conjunction with or as a follow-up to a Pap test (cell cytology), which examines cervical cells for changes that might become cervical cancer.

Today’s approval expands the use of the test to include use as either a co-test or as a primary cervical cancer screening test; however, it does not change current medical practice guidelines for cervical cancer screening. These guidelines are developed, reviewed and modified by groups other than the FDA.

Genital HPVs are a group of more than 40 related viruses and, according to the Centers for Disease Control and Prevention (CDC), are the most common sexually transmitted infections. Approximately 14 "high-risk" HPV types are associated with cervical cancer. In most cases, a high-risk HPV infection goes away on its own and does not cause any health problems. However, about 10 percent of women infected with high-risk HPV develop a persistent infection which may put them at risk of cancer. Virtually all cervical cancers are caused by HPV infections, with just two types, HPV 16 and HPV 18, responsible for approximately 70 percent of cervical cancers.

Data supporting the use of the cobas HPV Test as a primary screening test for cervical cancer included a study of more than 40,000 women 25 years and older undergoing routine cervical exams. Women who had a positive Pap test or whose cervical cells screened positive for HPV, as well as a subset of women whose Pap and HPV tests were both negative, underwent a colposcopy and cervical tissue biopsy. All biopsy results were compared to the Pap and cobas HPV Test results. Data from this study, which included three years of follow-up on women who went to colposcopy, showed that the cobas HPV Test is safe and effective for the new indication for use. 

The cobas HPV Test is manufactured by Roche Molecular Systems, Incorporated, Pleasanton, Calif.

For more information:



Food and Drug Administration. FDA Approves First Human Papillomavirus Test for Primary Cervical Cancer Screening. Press release. April 24, 2014.

Roche. FDA Approves Roche’s HPV Test for Identifying Women at Highest Risk for Cervical Cancer. Press release. April 20, 2014.

Society of Gynecologic Oncology. Primary HPV Screening Offers Important New Option for Cervical Cancer Detection, Prevention. Press release. April 24, 2014.