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    cobas® HPV Test

    Risk matters. Deliver 3 results in 1 test for accuracy that your clinical partners expect and that patients deserve      

Meeting the needs for cervical cancer screening

The cobas® HPV Test allows clinicians to manage their patients with greater precision and efficiency by individually identifying the highest-risk genotypes, HPV 16 and HPV 18, while simultaneously providing pooled results for the twelve other high-risk HPV (hrHPV) genotypes.

The latest U.S. professional screening guidelines support the use of HPV 16 and 18 genotyping as an option in cervical cancer screening. The guidelines state that the preferred screening method is “co-testing” with a Pap test and an HPV DNA test for women aged 30-65 years. Individual genotyping for HPV 16 alone, or HPV 16 and 18, is a recommended option for women who have a negative cytology (Pap test) but have positive results on a test for “pooled” hrHPV types.1

By providing 3 results in 1 test run, the cobas® HPV Test gives labs the confidence to deliver reliable results to clinicians for all HPV testing needs:  

  • Reflex testing for women with ASC-US cytology
  • Co-testing for women 30-65 years
  • Genotyping for HPV 16 and 18 for best risk assessment

Using a test that detects HPV DNA is important because guideline-creating organizations, such as ACOG, ACS, ASCCP, and NCCN, base their screening guidelines on results obtained from an HPV DNA test.2,3

The cobas® HPV Test gives clinicians the information they need to make timely and efficient clinical decisions. 

CLINICIAN INSIGHTS

"The simultaneous 16/18 genotyping makes it easier for me to follow the recently updated ACOG guidelines for cervical cancer screening, which recognize the benefits of genotyping for HPV 16 or HPV 16/18 in this population.”

Dr. Kevin Hamilton

Kevin Hamilton, MD

Chief of Staff, Summit Medical Center, Nashville, TN

 Learn More

U.S. Clinical Screening Guidelines

ACOG Guidelines

Support co-testing and reflex genotyping for HPV 16 and 18

The American College of Obstetricians and Gynecologists (ACOG) recommends that co-testing using the combination of Pap cytology plus high-risk HPV DNA testing is the preferred cervical cancer screening method for women aged 30-65 years. Any low-risk woman aged 30-65 years who receives negative test results on both Pap cytology screening and HPV DNA testing should be rescreened in 5 years.4

Immediate HPV genotype-specific testing for HPV 16 alone or HPV 16/18 can be used as an adjunct in women with negative Pap test results, but who have tested positive for hrHPV by an assay testing for 13 or 14 high-risk types.

  • Women who test positive for HPV 16 or HPV 16/18 should be referred directly for colposcopy.
  • Women with negative results for HPV 16 or HPV 16/18 should be co-tested in 12 months.

Learn more about the ACOG screening guidelines.        

ASCCP, ASCP, & ACS Screening Guidelines

Individual genotyping for HPV 16 or HPV 16 and 18 recommended as an option for hrHPV+ women with normal cytology.

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).

The societies recommend that 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 aged 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. 

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.

See the societies’ screening guidelines algorithm.       

  • Acronyms:

References:

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

2. cobas® HPV Test [package insert, US]. Branchburg, NJ: Roche Molecular Systems, Inc; 2016.

3. Saslow, Debbie, et al. 2012. 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. CA Cancer J Clin 2012;62(3):147-172.

4. The American Congress of Obstetricians and Gynecologists. ACOG Practice Bulletin. Clinical Management Guidelines for Obstetrician-Gynecologists: Screening for Cervical Cancer. November, 2012.