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Hologic Releases the Results of the Cervista(TM) HPV Clinical Trials
Date:11/13/2008

with a corresponding negative predictive value of 99.1%. Patients with CIN2 are at risk of developing cervical cancer, however this risk is not as high as it is for those diagnosed with CIN3.

-- When compared to the ASC-US/LSIL Triage Study (ALTS), the Cervista HPV high-risk test has a comparable specificity to the test used in that study. The ALTS trial is the best comparative trial for the Cervista HPV high-risk trial based on similarities in trial design.

The Cervista HPV high-risk test has additional advantages including:

-- The Cervista HPV high-risk test has demonstrated a low indeterminate rate (i.e. inability of the test to give a result) of less than 1% and no cross reactivity with commonly reported low-risk HPV types.

-- An internal control that minimizes the potential for a false negative result due to insufficient sample cellularity.

-- Small volume of liquid-based cytology sample required for HPV testing. Hologic believes that this will reduce the percentage of "quantity not sufficient" samples that are burdensome to the lab, physicians and patients alike.

-- Workflow advantages for the laboratory. The Cervista HPV high-risk test requires minimal hands on time, and yields a rapid time to results.

In addition to the results for the Cervista HPV high-risk test, Hologic also announced today the clinical trial results for the Cervista 16/18 test, a genotyping test for high-risk HPV types 16 and 18, which are responsible for approximately 70% of all cervical cancers. The Cervista(R) 16/18 test is also pending FDA approval. Similar to the high risk screening test, the Cervista 16/18 test results were compared to CIN2 and CIN3 clinical end-points. Two potentially important findings were Negative Predictive Values for 99.5% for CIN3 and 97.7% for CIN2+. Recent consensus guidelines released by the American Society for Colposcopy and Cervical Pathology (ASCCP) in 2007 stated that "...it would be reasonable to util
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SOURCE Hologic, Inc.
Copyright©2008 PR Newswire.
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