UPDATE: On April 24, 2014, the FDA approved the test discussed in the news item below. It is the first FDA-approved HPV DNA test for women 25 years of age and older that can be used alone to help assess the need for a woman to undergo additional diagnostic testing for cervical cancer.
Original article published April 14, 2014:
A U.S. Food and Drug Administration (FDA) Microbiology Devices Panel of the Medical Devices Advisory Committee recently voted unanimously to recommend to the FDA that a human papilloma virus (HPV) test be approved for marketing in the U.S. as a primary screening tool for cervical cancer.
Currently, only the Pap smear, widely available for decades, is used for primary testing. Pap smears are used to detect abnormal or potentially abnormal cells from the vagina and cervix. HPV tests detect the genetic material (DNA) of the virus in a sample of cells from the cervix and help identify women who may be at risk of cervical cancer. They have been recommended by several major health organizations but only in conjunction with or as a follow up to Pap smears. The advisory committee also recommended that the age for women to be offered an HPV test be lowered from 30 to 25.
The FDA is responsible for approving laboratory tests before they can be marketed in the U.S. by their manufacturers. The agency often follows the advice of its advisory committees but is not required to do so. Advisory Committee members typically include experts in the field from academic health centers, industry, community practice, and consumer advocates.
The Advisory Committee evaluating the HPV test reviewed data from a clinical trial that included over 40,000 women. The members voted only on a specific HPV test made by one company, but several other companies manufacture HPV tests and could submit requests to the FDA for approval for first line screening.
Most cervical cancers are caused by HPV, a sexually transmitted infection, in particular HPV strains 16 and 18. The American Cancer Society estimates that over 12,000 new cases of invasive cervical cancer will be diagnosed in 2014 and about 4,000 women will die from cervical cancer. Between 1955 and 1992, the cervical cancer death rate declined by almost 70%, in large part because of Pap testing. However, the death rate has remained at its current level for the past few years.
The recommended test simultaneously screens for HPV 16 and HPV 18 individually and twelve other HPV strains (as a group) that put women at high risk for cervical cancer. If the test is approved for marketing as first line testing, women who test positive for HPV 16 and HPV 18 may then undergo colposcopy. With colposcopy, a physician uses a device to get a closer look at the cervix, to take a sample of cells for further testing for cancer and treat abnormal areas as necessary. Women who screen negative for HPV 16 or HPV 18 but positive for other high risk strains would have a Pap smear to see if colposcopy is needed.
If approved for primary screening, the HPV test would not necessarily completely replace the Pap smear but would more likely become another option for screening, at least in the next few years. It may take some time for an HPV screening test to become a routine part of practice because the Pap test is so widely used. Before offering HPV screening to their patients, healthcare practitioners may wait for recommendations from professional health organizations that would need time for their own committees to review the data and present their conclusions and for the organizations to change their guidelines for cervical cancer screening.
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NOTE: This article is based on research that utilizes the sources cited here as well as the collective experience of the Lab Tests Online Editorial Review Board. This article is periodically reviewed by the Editorial Board and may be updated as a result of the review. Any new sources cited will be added to the list and distinguished from the original sources used.
Mar 12, 2014. Frieden, J. FDA Panel: Roche's DNA Test Can Replace Pap Smear. Medpage Today. Available online at http://www.medpagetoday.com/OBGYN/GeneralOBGYN/44745 through http://www.medpagetoday.com. Accessed March 23, 2014.
March 12, 2014. Pollack, A. F.D.A. Panel Recommends Replacement for the Pap Test. New York Times Health. Available online at http://www.nytimes.com/2014/03/13/health/an-fda-panel-recommends-a-possible-replacement-for-the-pap-test.html?_r=0 through http://www.nytimes.com. Accessed March 23, 2014.
March 13, 2014. FDA Panel Recommends HPV Test As Replacement for Pap Smear. HealthDay. Available online at http://www.nlm.nih.gov/medlineplus/news/fullstory_145075.html through http://www.nlm.nih.gov. Accessed March 23, 2014.
March 14, 2014. Willingham, V. FDA: Use HPV tests over Pap tests to find cervical cancer. CNN Health Available online at http://www.cnn.com/2014/03/13/health/pap-test-fda/ through http://www.cnn.com. Accessed March 25, 2014.
March 13, 2014. Media Release: FDA Advisory committee unanimously recommends Roche's HPV Test as primary screening tool for detection of women at high risk for cervical cancer. Roche. Available online at http://www.roche.com/media/media_releases/med-cor-2014-03-13.htm through http://www.roche.com. Accessed March 25, 2014.
(April 11, 2013) American Cancer Society. What Are the Key Statistics About Cervical Cancer? Available online at http://www.cancer.org/cancer/cervicalcancer/detailedguide/cervical-cancer-key-statistics through http://www.cancer.org. Accessed March 25, 2014.
Stoler MH, Wright TC, Sharma A, et al. High-risk human papillomavirus testing in women with ASC-US cytology: results from the ATHENA HPV study. Am J Clin Pathol. 2011;135(3):468-475. Available online at http://ajcp.ascpjournals.org/content/135/3/468.long Accessed April 2014.
Castle PE, Stoler MH, Wright TC Jr., Sharma A, Wright TL, Behrens CM. Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening of women aged 25 years and older: a subanalysis of the ATHENA study. Lancet Oncol. 2011;12(9):880–890.
FDA News Release. FDA approves first human papillomavirus test for primary cervical cancer screening. April 24, 2014.