Genotyping for High-risk HPV Types 16 & 18
What is HPV genotyping? If you are age 30 or older, you may have an HPV test along with your Pap test to screen for cervical cancer. If your Pap test is normal but your HPV test is positive your healthcare provider may recommend a follow-up “genotyping” test. The “genotyping” test will determine whether or not an HPV infection is caused by either HPV type 16 and/or HPV type 18. These are the two HPV types found in 70% of cervical cancers. If you test positive for type 16 or type 18, this does not mean that you have or will have cervical cancer. It does indicate that you are at greater risk for cervical disease and cancer and may require closer surveillance by your healthcare provider.
Increased Risk of Developing Cervical Cancer
You are 5.5 and 4.5 times more likely to develop cervical cancer when infected by HPV Types 16 and/or 18 versus all other high-risk HPV Types (1).
What HPV genotyping tests are currently available?
The Cervista ®16/18 test is the only FDA approved HPV test currently available to determine the presence or absence of HPV types 16 and/or 18. The Cervista®HPV 16/18 test was approved by the FDA in 2009. As a result, of this approval, the American Society for Colposcopy and Cervical Pathology (ASCCP) issued guidelines that would allow women age thirty and older who are infected with a high-risk HPV while having a normal pap test to be genotyped with the Cervista HPV 16/18 test. Those women who were not positive for either type 16 or type 18 could avoid additional treatment and return to routine screening; while those found positive for either type may be referred to colposcopy for further evaluation.
Who Should Be Tested?
While the role of genotyping continues to evolve, guidelines have been issued to address cytology negative, HPV positive women 30 years of age and older. This recommendation issued by the American Society for Colposcopy and Cervical Pathology (ASCCP) states that "…in cytology negative women 30 years and older who are HPV DNA positive (for any of the 13 or 14 high-risk types of HPV detected by the high-risk HPV assays) molecular genotyping assays that detect HPV 16 and 18 would be clinically useful for determining which women should be referred for immediate colposcopy, and which could be followed-up with repeat cytology and high-risk HPV testing in 12 months (2)."
What are the FDA approved indications for the Cervista® HPV 16/18 test?
- In women 30 years and older the Cervista®HPV 16/18 test can be used adjunctively with the Cervista® HPV HR test in combination with cervical cytology to assess the presence or absence of high-risk HPV types 16 and 18. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.
- To be used adjunctively with the Cervista®HPV HR test in patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, to assess the presence or absence of high-risk HPV types 16 and 18. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy.
For more information on genotyping visit:
The American Social Health Association: http://www.ashastd.org
Cervista HPV tests: http://www.cervistahpv.com/
References:
1. Khan, et al., Journal of the National Cancer Institute, Vol. 97, No. 14, July 20, 2005, pg. 1078
2. American Society for Colposcopy and Cervical Pathology. Algorithms 2006 Consensus Guidelines for the Management of Women with Cervical Cytological Abnormalities. JLGTD 2007;11(4):201-222
