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Cervista HPV 16/18 Assay

The Cervista HPV 16/18 assay helps guide clinicians’ treatment decisions by individually identifying and differentiating high-risk human papillomavirus (HPV) types 16 and 18 — the two most highly oncogenic and persistent high-risk HPV types known to cause high-grade cervical neoplasia. Adding this assay as a reflex test for patients testing positive with the Cervista HPV HR assay facilitates risk-stratification of patients at greater risk for cervical disease, supporting clinicians to better manage and tailor care.

About

Using the same technology as the Cervista HPV HR assay, the Cervista HPV 16/18 genotyping assay provides DNA testing for both the high-risk HPV 16 and HPV 18 oncogenes.   The Cervista HPV 16/18 test can used adjunctively with the Cervista HPV HR test in patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, and it may be run from the same 2-ml specimen. 

Clinicians and scientists agree that targeting HPV 16/18 with the Hologic Cervista HPV 16/18 assay is critical to identifying patients at risk for cervical cancer.  

“Given that HPV 16 and HPV 18 are estimated from cross-sectional data to cause 70% of cervical cancers worldwide and that the cumulative risk of (CIN3+) in women with HPV 16 or HPV 18 ranges from 10% to 20%, we conclude that these two HPV types are potent carcinogens and should be more effectively targeted in clinical practice.”

Khan, et al., Journal of the National Cancer Institute 2005Vol. 97, No. 14, July 20, 2005, pg. 1078

 

“…there is compelling evidence that HPV 16 and HPV 18 are the most oncogenic types and might warrant separate detection performed either as a triage for an oncogenic HPV-positive test or concurrently with the pooled oncogenic test.”

Meijer, et al., Gynecologic Oncology 2006 (103), 2006, pg. 13

 

“...emerging data support the triage of women 30 years of age and older with a cytology result of ‘negative for an intraepithelial lesion or malignancy,’ but who are HPV-positive with HPV genotyping assays to identify those with HPV 16 and 18.”

Wright et al. 2007 (American Society for Colposcopy and Cervical Pathology): American Journal of Obstetrics & Gynecology, October 2007, pg. 353

Performance Data

Risk stratification using HPV types 16 and 18, Portand Study Findings:1,2

  • CIN3+ identified in 21% of cytology-negative, HPV 16-positive women at 10-year follow-up.

  • CIN3+ identified in 18% of cytology-negative, HPV 18-positive women at 10-year follow-up.

  • CIN3+ identified in only 1.5% of all other cytology-negative, high-risk HPV positive women at 10-year follow-up.

 

HPV HR 16/18

Regulatory

The Cervista HPV HR assay was FDA-approved for in vitro diagnostic use in the U.S. in March 2009. The Cervista HPV HR assay was CE-marked in December 2007. 

For additional availability in other countries beyond the U.S., please contact your local sales representative or distributor.

References

1. Khan, et al., Journal of the National Cancer Institute, Vol. 97, No. 14, July 20, 2005, pg. 1078. 

2. Wright, Massad, Dunton, Spitzer, Wilkinson, Solomon (American Society for Colposcopy and Cervical Pathology): American Journal of Obstetrics & Gynecology, October 2007, pg. 35.