HPV test approved as first-line screening
The Food and Drug Administration (FDA) has for the first time approved a human papillomavirus (HPV) test that can be used alone instead of the Pap test to screen for cervical cancer. The cobas HPV Test, manufactured by Roche Molecular Systems in Pleasanton, CA, received the agency’s nod for use as a first-line primary screening test for cervical cancer in women ages 25 and older.
The regulatory approval offers women and physicians a new option for cervical cancer screening, said Alberto Gutierrez, PhD, director of the FDA’s Office of In Vitro Diagnostics 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." said Gutierrez in a statement accompanying the agency’s action.
The cobas test initially received FDA approval in 2011 for use with or as a follow-up to cytology testing. (Contraceptive Technology Update reported on the approval. Read "New HPV test gains approval from FDA," July 2011, p. 77.) The test specifically identifies HPV genotypes 16 and 18, which are responsible for about 70% of all cervical cancers, and concurrently detects 12 other high-risk genotypes (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68).
The FDA points to data supporting the use of the cobas HPV Test as a primary screening test for cervical cancer as basis for its approval. These data include a study of more than 40,000 women age 25 and older undergoing routine cervical exams. To conduct the study, 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 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, show that the cobas HPV Test is safe and effective for the new indication, states the FDA.1
Will guidance change?
The American Cancer Society and the American Society for Colposcopy and Cervical Pathology (ASCCP) issued guidance in 2012 recommending using Pap and HPV tests together every five years, called co-testing, or a Pap test alone every three years for women 30-65. For women ages 21 through 29, the guidelines recommend a Pap test every three years, with an HPV test only if the Pap is abnormal. Screening is not recommended for women younger than age 21.2 (To read more, see "Guidance issued on cervical cancer screening: update your practice now," June 2012, p. 61.)
Will current guidance be revised to include the HPV test as a first-line test? The ASCCP, the Society for Gynecologic Oncology, and other organizations are developing an interim guidance document for further clarification on use of the newly approved test. "We’re energized by the attention to this important women’s health issue and the opportunity to increase available cervical cancer screening tools for the medical community," said Herschel Lawson, MD, ASCCP chief medical officer and adjunct associate professor of gynecology and obstetrics at Emory University School of Medicine in Atlanta, in a released statement. "While existing guidelines for use of cervical cytology alone and cytology/HPV cotesting are not likely to change in the near future, we look forward to providing guidance for integrating primary HPV testing into our collection of recommended screening protocols to facilitate individual patient needs for appropriate cervical cancer screening and indicated follow up."
In the meantime, the ASCCP and the Society for Gynecologic Oncology continue to direct clinicians to current guidance, which indicate use of the HPV test when Pap test results are inconclusive and in women age 30 and older in combination with a Pap test. (Download the screening and management guidelines at http://bit.ly/1j1x7zS.)
Between the 1940s and 2002, women in the United States were advised to have cervical cytology screening for cervical cancer performed annually at the time of their well woman visit, says Michael Policar, MD, MPH, clinical professor of obstetrics, gynecology, and reproductive sciences, at the University of San Francisco (UCSF) and medical director of UCSF’s Family PACT Evaluation program. "Over the past decade, however, national guidelines have changed substantially, such that routine screening is started later, completed earlier, and intervals extended to every three to five years for most women," said Policar in a late breaker session at the 2014 Contraceptive Technology conferences in San Francisco and Boston.3
Because there has been no national consumer education campaign regarding the rationale for the changes in the 2012 guidelines, many women reject them as being financially motivated and not in the best interest of their health, noted Policar. Some clinicians are reluctant to change their screening practices as well, said Policar. In one study, results indicate physicians thought that patients were uncomfortable with extended screening intervals and were concerned that patients would not come for annual exams without concurrent cytology screening.4
Despite these obstacles, clinicians should take the time to discuss with each woman the interval that applies to her and to counsel her that being screened too often can be harmful to her health, stated Policar.
"Over-screening minimally improves lesion detection rates, but it results in an excess risk of false positive tests, which can lead to unnecessary colposcopy and biopsies, with attendant anxiety and inconvenience, as well as unnecessary financial costs to the patient and the health delivery system," noted Policar.
- Food and Drug Administration. FDA approves first human papillomavirus test for primary cervical cancer screening. Press release. Accessed at http://1.usa.gov/1ijaTm1.
- Saslow D, Solomon D, Lawson HW, et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. Am J Clin Pathol 2012;137(4):516-542.
- Policar M. Applying the "new" cervical cytology guidelines in your practice. Presented at the 2014 Contraceptive Technology conferences. San Francisco, March 2014 and Boston, April 2014.
- Perkins RB, Anderson BL, Gorin SS, et al. Challenges in cervical cancer prevention: A survey of U.S. obstetrician-gynecologists. Am J Prev Med 2013; 45(2):175-181.
