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Performance

  • The Cervista® HPV HR clinical trial screened > 50,000 women
  • Samples collected from 89 locations in 23 states, providing geographic diversity
  • Included both ASC-US (>1,500 women) and normal cytology (>2,000 women) arms
  • All clinical objectives achieved

CIN3+ detection:

Cervista HPV HR versus Colposcopy/Consensus Histology results (CIN3+) among women with ASC-US cytology.

1No CIN, CIN1 or CIN2 by Central Histology or Colposcopy without Central Histology.

CIN2+ detection:

Cervista HPV HR versus Colposcopy/Consensus Histology results (CIN2+) among women with ASC-US cytology.

1No CIN or CIN1 by Central Histology or Colposcopy without Central Histology.

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Comparison of Cervista HPV HR clinical trial and ALTS

Organized and funded by the National Cancer Institute, the four-year ASC-US Triage Study (ALTS) included over 5,000 patients. It was designed to help women and their doctors decide what to do about these mildly abnormal Pap test results. This trial remains the benchmark ASC-US triage study. Here’s how Cervista HPV HR compares with ALTS findings.

Conclusion

This extensive multi-center study demonstrated that Cervista HPV HR delivers ease-of-use and clear results—it does not sacrifice performance or accuracy. For example:

  • In one of the largest and most demographically diverse prospective clinical trials since ALTS, Cervista HPV HR demonstrated clear clinical utility.
  • Laboratories adopting Cervista HPV HR can expect both accurate results and substantially enhanced ease-of-use.

aCervista HPV HR multicenter clinical trial, 2006-2008. Clinical and analytical data on file, Hologic, Inc.

bImmediate colposcopy arm of ALTS.

cNumber of subjects with known disease status and Cervista HPV HR results.

dReferral rate for women 30 years of age and older was 43%.