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

ize genotyping in cytology negative, HPV-positive women in the same manner as high-risk HPV testing is utilized in women with ASC-US." If regulatory approvals for the Cervista 16/18 test are obtained, Hologic will be well positioned to work with professional societies, physicians and laboratories to address the needs of this group of women.

The results of these clinical trials combined with the other attributes of the test should allow Hologic to compete in the rapidly growing HPV testing market both in the U.S. and internationally. The Cervista HPV high-risk test is currently under review by the FDA in the U.S. Hologic has obtained CE marking of the Cervista HPV test and is currently in the final stages of obtaining CE Mark approval for the sample preparation component of the test. The company expects to launch the product in the EU in January 2009.

About Hologic, Inc.

Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic's core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging and molecular diagnostic products including reagents for a variety of DNA and RNA analysis applications. For more information, visit http://www.hologic.com.

Forward-Looking Disclaimer

This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the effect and adoption of the use of the Cervista HPV testing products. There can be no assurance that the tests will ach
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SOURCE Hologic, Inc.
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