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FDA APPROVES APTIMA HPV ASSAY FOR USE ON HOLOGIC'S PANTHER SYSTEM
Date:7/23/2013

BEDFORD, Mass., July 23, 2013 /PRNewswire/ -- Hologic, Inc. (Hologic or the Company) (NASDAQ: HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products, with an emphasis on serving the healthcare needs of women, announced today that the U.S. Food and Drug Administration (FDA) has approved Hologic's Aptima HPV assay for use on the Company's fully-automated Panther system. The Aptima HPV test is performed with Hologic's ThinPrep liquid cytology specimen and can be tested before and after it has been processed for cytology testing on the ThinPrep 2000 system.

Hologic's Aptima HPV mRNA based assay is a nucleic acid amplified test that detects 14 high-risk strains of human papillomavirus (HPV) associated with cervical cancer and precancerous lesions, and has demonstrated significantly improved specificity with no compromise in disease detection. The addition of the Aptima HPV assay to the Panther menu extends the capability of low to high-volume laboratories to run multiple tests from a single specimen, on a cost effective, highly flexible and fully-automated molecular testing platform.

Created to be a "sample-in-result-out" instrument, the Panther system eliminates batch processing and automates all aspects of nucleic acid testing on a single, integrated platform.

"Our Panther system is a world-class automation solution for a broad range of molecular diagnostic laboratories," said Rohan Hastie, Senior Vice President and General Manager, Diagnostics. "Expanding the menu of available assays on Panther builds on our platform-centric strategy of delivering workflow efficiencies and revenue generating opportunities to our laboratory partners."

About the Hologic Aptima HPV Assay

The Aptima HPV assay detects messenger RNA overexp
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SOURCE Hologic, Inc.
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