Hologic Human Papillomavirus (HPV) High-Risk Test Approved for Use in The Netherlands Population Cervical Screening Programme

BEDFORD, Mass., July 18, 2012 /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 dedicated to serving the healthcare needs of women, announced today that the NVVP (Netherlands Society for Pathology) has approved the use of the Hologic Cervista HPV HR test for detecting human papillomavirus in the Dutch national cervical screening programme.[i]

HPV is one of the most common sexually transmitted diseases (STD) and is recognized as the cause of most cervical cancers. To help prevent the onset of disease, the RIVM (National Institute for Public Health and the Environment in The Netherlands) suggests routine Pap testing and HPV HR triage for ASCUS/LSIL testing for women over the age of 30 to identify women most likely to develop cervical cancer.[ii]

"We are extremely excited to enter the Netherlands Cervical Screening Programme with our Hologic Cervista HPV HR test for detecting HPV," said Rohan Hastie, Ph.D., Hologic Vice President & General Manager of Diagnostics. "The Cervista HPV HR test includes an internal control intended to verify adequate cellularity for testing, thus reducing the potential for false negative results," Dr. Hastie added. "Because it requires a smaller specimen volume, this test may minimize inconclusive or indeterminate results, which may lead to fewer patients being called back for repeat testing. More importantly, the test is designed to minimize false positive results due to a low-risk HPV strain being mistakenly recognized as a high-risk HPV strain, thereby potentially reducing unnecessary clinical management and patient anxiety. The test is built on redundancy and focused on the L1/E6E7 region so it protects against false negative outcomes in the event of L1 deletion."

About the Cervista HPV HR Test

The Cervista HPV HR test is based on Invader chemistry, a patented technology owned by Hologic and well established in other areas of molecular testing. The test utilizes the sample collected with the Hologic ThinPrep Pap test, offering additional convenience for the healthcare provider and the test is integrated to work on the Hologic Cervista MTA (Medium Throughput Automation) system for the extraction of DNA and HPV detection.

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, breast magnetic resonance imaging, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia and uterine fibroids, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging and molecular diagnostic products including HPV and reagents for a variety of DNA and RNA analysis applications.

Hologic, Cervista, Invader, ThinPrep and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.

Forward-Looking Statement Disclaimer

This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the use of the Hologic Cervista HPV HR and ThinPrep Pap tests. There can be no assurance the tests or systems will achieve the benefits described herein and that such benefits will be replicated in any particular manner as the actual effect of the use of the tests and systems can only be determined on a case-by-case basis depending on the particular circumstances and installation in question. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein to reflect any change in the Company's expectations or any change in events, conditions or circumstances on which any such data or statements are based. Certain factors that could adversely affect the Company's business and prospects are described in Hologic filings with the Securities and Exchange Commission.

Contacts:

[i] www.pathology.nl [Netherlands Society for Pathology]
[ii] www.rivm.nl  [National Institute for Public Health and the Environment]

SOURCE Hologic, Inc.