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Cervista® HPV 16/18

Cervista HPV 16/18 individually identifies and differentiates high-risk types 16 and 18

 Cervista HPV 16/18
  • Identifies the two most highly oncogenic and persistent high-risk HPV types known
    to cause high-grade cervical neoplasia
  • Facilitates risk-stratification of patients at greater risk for cervical disease in order to
    tailor care more appropriately
  • Uses the same technology as Cervista HPV HR, and the test may be run from the
    same 2 ml specimen

The Value of 16/18 Genotyping in Literature

“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”1

Khan, et al., Journal of the National Cancer Institute 2005

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-yr. follow-up
  • CIN3+ identified in 18% of cytology-negative, HPV 18-positive women at 10-yr. follow-up
  • CIN3+ identified in only 1.5% of all other cytology-negative, high-risk HPV positive women at 10-yr. follow-up
 HPV HR 16/18

“…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.”4

Meijer, et al., Gynecologic Oncology 2006

“...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.”2

Wright et al 2007

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. 353

3 Clinical and analytical data on file, Hologic, Inc.

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