ACS, ASCCP, & ASCP 2012 guidelines update
In March 2012, new guidelines for the prevention and early detection of cervical cancer were issued jointly by the American Cancer Society (ACS), the American Society for Colposcopy and Cervical Pathology (ASCCP), and the American Society for Clinical Pathology (ASCP).
Using human papillomavirus (HPV) testing in addition to a Pap test (also known as co-testing) is preferable to using a Pap test alone for women ages 30 – 65 years. The recommendation for co-testing is based on evidence showing that adding an HPV test to cytology increases detection of cervical precancer and reduces the rate of invasive cervical cancer, compared to using a Pap test alone.
Individual genotyping for HPV 16 or HPV 16 and 18 recommended as an option for hrHPV+ women with normal cytology.
Moreover, the societies now recommend that individual genotyping for HPV 16 or HPV 16 and 18 may be used when women have a negative cytology (Pap test) but have positive results on a test for “pooled” high-risk HPV types. As an alternative for managing these patients, the guidelines continue to offer the option of repeating Pap and HPV testing at a one-year interval.
Roche’s landmark ATHENA study is cited by the professional organizations as a central study providing the evidence for differential patient management based on HPV 16 and 18 DNA genotyping.
Request copies of the clinical research manuscripts.
HPV and cytology co-testing, and HPV genotyping, in women aged 30-65
|Population||Recommended screening method*||Management of screening results||Comments|
|<21 years||No screening||HPV testing should NOT be used for screening or management of ASC-US in this age group.|
|21-29 years||Cytology alone every 3 years||HPV-positive ASC-US or cytology of LSIL or more severe: refer to ASCCP guidelines
Cytology negative or HPV-negative ASC-US† : rescreen with cytology in 3 years
|HPV testing should NOT be used for screening in this age group.|
|30-65 years||HPV and cytology “co-testing” every 5 years (preferred)||HPV-positive ASC-US or cytology of LSIL or more severe: refer to ASCCP guidelines||Screening by HPV testing alone is not recommended for most clinical settings|
HPV-positive, cytology negative:
Option 1 – 12 month follow up with co-testing
Option 2 – Test for HPV 16 or HPV 16/18 genotypes, if HPV 16 or HPV 16/18 positive: refer to colposcopy; if HPV 16 or HPV 16/18 negative: 12 month follow up with co-testing
Co-test negative or HPV-negative ASC-US: rescreen with co-testing in 5 years
|Cytology alone every 3 years (acceptable)||HPV-positive ASC-US or cytology of LSIL or more severe: refer to ASCCP guidelines|
|Cytology negative or HPV-negative ASC-US: rescreen with cytology in 3 years
|>65 years||No screening following adequate negative prior screening||Women with a history of CIN2 or a more severe diagnosis should continue routine screening for at least 20 years.|
|After hysterectomy||No screening||Applies to women without a cervix and without a history of CIN2 or a more severe diagnosis in the past 20 years of cervical cancer ever.|
|HPV vaccinated||Follow age-specific recommendations (same as unvaccinated women)|
*Women should not be screened annually at any age by any method.
†ASC-US cytology with secondary HPV testing for management decisions.
Additional key considerations from the guidelines
Advice regarding the use of tests that have not been clinically validated*
The guidelines recommend/caution:
In the screening guidelines, HPV refers only to high-risk HPV.
*Guidance for clinical validation of an HPV test is described in the following publications: Stoler MH, et al. Am J Clin Pathol. 2007;127:335-337 and Meijer C, et al. Int J Cancer. 2009;124:516-520.
1.Saslow D et al, Journal of Lower Genital Tract Disease, Volume 16, Number 3, 2012