Introducing Cervista HPV

Cervista HPV HR

Clinical Integrity and Reliable Results

When relying on a diagnostic test to make clinical management decisions, nothing is more important than the integrity and accuracy of the results. In one of the largest and most demographically diverse clinical trials since the landmark ASC-US LSIL Triage Study (ALTS) trial, Cervista® HPV HR achieved all clinical objectives. The trial included 89 collection centers in 23 states and enrolled approximately 4,000 patients. Cervista HPV HR attained 100% sensitivity for CIN3+, an immediate precursor to cervical cancer, and demonstrated comparable outcomes as seen in the ALTS trial. 1,2

Clinical Trial Results

Cervista HPV HR achieved 100% sensitivity and 100% negative predictive value for the detection of CIN3+, an immediate precursor to carcinoma in situ.1,2

Comparison of Cervista HPV HR Clinical Trial and ALTS

Organized and funded by the National Cancer Institute, the four-year ALTS trial studied more than 5,000 patients. Designed to help women and physicians make informed decisions about slightly abnormal pap results, the trial remains the benchmark ASC-US triage study. Here’s how Cervista HPV HR clinical trial results compare with ALTS findings.

With a rigorous clinical trial design, Cervista HPV HR demonstrated clear clinical utility based on highly accurate results that correlate favorably with ALTS data.

References

1. 100% CIN3 Detection in ASC-US: 95% CI (85.1% - 100%)

2. Consult package insert for full clinical details: Cervista®

Learn more about the advanced clinical performance and improved workflow offered by Cervista HPV HR in the laboratory.

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