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

BEDFORD, Mass., Nov. 13 /PRNewswire-FirstCall/ -- Hologic, Inc. (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced the results of the Cervista HPV high-risk pivotal clinical trial. The Cervista HPV high-risk test is currently under review by the FDA in the U.S. and is expected to be launched in the European Union (EU) early in 2009. The clinical and analytical performance of Cervista HPV high-risk test results are scheduled to be presented at the European Research Organization on Genital Infection and Neoplasia (Eurogin) HPV conference in Nice, France on Saturday, November 15th 2008. Due to an early publication of the abstract by the conference organizers, Hologic has brought forward the release of this data.

The Cervista HPV high-risk test is designed to detect the 14 high-risk types of HPV that cause cancer. The proposed intended use of the test is as a general screen, in combination with cervical cytology (pap test), to help guide patient management for women 30 years of age or older, and as a triage for ASC-US cytology results to determine the need for referral to colposcopy. The trial enrolled over 4,000 women including more than 1,300 women with equivocal pap results called ASC-US, from 89 locations across the United States. Hologic is pleased to announce that the clinical trial met or exceeded all of the target end points. The results of the study were as follows:

-- 100% CIN3 detection and a corresponding negative predictive value of 100%. Patients with CIN3 are at the highest risk of developing cervical cancer.

-- The sensitivity of the test for CIN2+ was 92.8%,
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SOURCE Hologic, Inc.
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