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Medical Societies Recommend Consideration of Primary HPV Testing for Cervical Cancer Screening

Chicago, Jan. 8 2015—Two leading medical organizations say that using a Human papillomavirus (HPV) test alone for cervical cancer screening is an effective alternative to the current recommendation for screening with either cytology (the Pap test) alone or co-testing with cytology and HPV testing.

The Society of Gynecologic Oncology (SGO) and the American Society for Colposcopy and Cervical Pathology (ASCCP) issued an Interim Guidance Report after the U.S. Food and Drug Administration (FDA) approved the cobas® HPV test as a “primary,” or first, test performed for cervical cancer screening. The test detects DNA from 14 high-risk HPV types, including types 16 and 18, which are responsible for 70 percent of cervical cancers. The guidance report is being jointly published online on Jan. 8 by Gynecologic Oncology, the Journal of Lower Genital Tract Disease, and Obstetrics and Gynecology. 

The Interim Guidance Report, “Use of Primary High Risk Human Papillomavirus Testing for Cervical Cancer Screening: Interim Clinical Guidance” will help doctors and other clinical providers determine how best to integrate primary HPV testing into the care of their patients until several medical societies update their evidence-based guidelines for cervical cancer screening. 

Cervical cytology, frequently called the “Pap” test, can detect abnormal cells in the cervix that could be pre-cancerous; follow-up and management leads to prevention of invasive cancer. Its widespread use in the U.S. is credited with greatly reducing both the occurrence of and deaths from cervical cancer.

As investigators learned about the role HPV plays in the development of cervical cancer, tests to detect the virus were developed and used in conjunction with cytology. Many studies now show that HPV testing may be more effective than cytology alone in detecting cervical pre-cancer. 

“Our review of the data indicates that primary HPV testing misses less pre-cancer and cancer than cytology alone. The guidance panel felt that primary HPV screening can be considered as an option for women being screened for cervical cancer,” said Warner K. Huh, MD, Division Director and Professor in the Division of Gynecologic Oncology at the University of Alabama, Birmingham. Dr. Huh is a spokesperson for the SGO and lead author of the Interim Guidance Report.

The Interim Guidance Report recommends:

  • Primary HPV testing can be considered for women starting at age 25.
  • Women under age 25 should continue to follow current guidelines that recommend cytology alone beginning at age 21. 
  • Women with a negative primary HPV test result should not be retested again for three years. This is the same screening interval recommended under current guidelines for a normal cytology test result. 
  • An HPV test positive for HPV 16 and 18, two types associated with a higher risk of future disease, should be followed with colposcopy, a test that allows the doctor to examine the cervix under illumination and magnification.
  • A test that is positive for HPV types other than 16 and 18 should be followed by reflex cytology testing. 

In developing the guidance report, the medical societies reviewed 11 studies, includingPrimary Cervical Cancer Screening with Human Papillomavirus: End of Study Results from the ATHENA Study Using HPV as the First-Line Screening Testalso published Jan. 8 in Gynecologic Oncology. This U.S. study demonstrated that primary HPV screening is an effective screening strategy in women 25 years and older. The authors of the guidance report noted the need for additional studies to further define the role of primary HPV screening and its integration with other existing guidance on screening for cervical cancer, and managing abnormal screening tests and diagnosed cervical pre-cancer.

“The introduction of cervical cytology screening was truly one of the great breakthroughs in medicine, and has saved countless lives,” said ASCCP’s Chief Medical Officer Herschel Lawson, MD. “We are lucky that we have so many tools available now to improve cervical cancer prevention efforts and afford patients options depending on their individual situations. We’ll continue to work to find the best way to combine screening tools with other prevention efforts like HPV vaccines, for the early detection and treatment of cervical cancer.  

“The most important message for providers and the community is that women should be screened for cervical cancer,” Dr. Lawson added. “Screening saves lives.” 

About SGO
The Society of Gynecologic Oncology (SGO) is a 501(c)6 national medical specialty organization of physicians and allied healthcare professionals who are trained in the comprehensive management of women with malignancies of the reproductive tract. The Society’s membership, totaling more than 1,800, is primarily comprised of gynecologic oncologists, as well as other related medical specialists including medical oncologists, radiation oncologists, nurses, social workers and pathologists. SGO members provide multidisciplinary cancer treatment including chemotherapy, radiation therapy, surgery and supportive care.

The American Society for Colposcopy and Cervical Pathology (ASCCP) is a 501(c)3 organization founded in 1964 as a non-profit specialty society. The ASCCP has since served as the primary source of postgraduate colposcopy training not only in the United States, but globally. ASCCP’s goal is to improve clinician competence, performance and patient outcomes through educational activities focused around the study, prevention, diagnosis, and management of lower genital tract disorders.  

Participating Organizations
American College of Obstetricians and Gynecologists
American Society for Clinical Pathology
American Society of Cytopathology
College of American Pathologists

FDA Approves a New HPV Vaccine

On Wednesday, December 10, 2014, the U.S. Food and Drug Administration (FDA) approved a new 9-valent Human papillomvirus (HPV) vaccine which protects against not only the four types included in the quadrivalent HPV vaccine, available since 2006, but five other types known to cause HPV-associated cancers.  The combination of genotypes in this vaccine will protect against 90% of HPV-associated cancers as well as most external genital warts.  

There are still many questions to be answered about the vaccine’s use, like how many doses will be needed, over what time period will the doses be given, and for whom will it be recommended. Also to be determined is whether or not a recommendation will be made for use of the new vaccine among individuals who’ve already received a full series of the either the quadrivalent or bivalent HPV vaccine.  The CDC Advisory Committee on Immunization Practices is expected to discuss many of these issues at its next meeting, in February, 2015, and proposed recommendations will be voted on at that time.  Until those decisions are made, remember that the quadrivalent HPV vaccine is still available  and is known to be highly effective in preventing external genital warts and HPV-associated cancers.  

ASCCP will be discussing HPV vaccination during its 2015 Clinical Update meeting in Baltimore, MD, June 5-7. Providers, be sure to discuss with your patients whether the vaccine is right for them.  Individuals, be sure to discuss whether the vaccine is right for you or your children with your regular health care provider.


FDA Announcement Expands Options for Cervical Cancer Screening
ASCCP releases statement in response to FDA Announcement

FDA approves first human papillomavirus test for primary cervical cancer screening
Please stay tuned. ASCCP and SGO are in the process of creating a guidance document - available as soon as final ATHENA study data is published.

CETC HPV utilization statement

The Cytopathology Education and Technology Consortium (CETC) recently provided an updated statement on human papillomavirus (HPV) DNA test utilization. This statement is a concise summary of the clinical indications for high-risk or oncogenic HPV testing based on guidelines from the American Society for Colposcopy and Cervical Pathology (ASCCP) and the American Cancer Society (ACS). 
--- Erratum


Press Release
Frederick, MD, March 21, 2013. -- The American Society for Colposcopy and Cervical Pathology (ASCCP) today released the Updated Consensus Guidelines for Managing Abnormal Cervical Cancer Screening Tests and Cancer Precursors.

The ASCCP of Service in Rwanda
ASCCP member and International Education & Humanitarian Outreach Committee member Lisa A. Lepine, MD is featured today in the Daily Camera. The article, “Boulder gynecologist passionate about preventive care in developing nations: Treatment and education both part of her medical arsenal,” highlights Dr. Lepine’s and the committee’s trip to the African developing country. More information on the ASCCP's mission will be featured as it becomes available. 

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