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The devil is in the details.

Get the facts. Know her risk.

Co-testing is preferable to using a Pap test alone for women ages 30–65.1

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

HPV and Cytology Co-testing, and HPV Genotyping in Women Aged 30-65

Summary of cervical cancer screening recommendations.1

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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: 

  • Against the use of Lab Developed Tests for cervical cancer screening.
  • Guidelines were developed based on HPV tests that have performance characteristics similar to those of the HPV tests used in the supporting evidence.
    • The guidelines cannot be expected to perform as designed (i.e. to balance benefits and harms) when using HPV tests with different performance characteristics. 

In the screening guidelines, HPV refers only to high-risk HPV.

  • Other HPV types should not be used in cervical cancer screening.
  • Testing for low-risk HPV types has no clinical role in cervical cancer screening or the evaluation of women with abnormal cytology.


*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.


  • Acronyms:

References:

1.Saslow D et al, Journal of Lower Genital Tract Disease, Volume 16, Number 3, 2012