Health Canada Approves Aptima HPV Assay for Use on Hologic's Panther System

The addition of Hologic's Aptima HPV assay to the fully automated Panther system expands the ability of laboratories to run multiple tests from a single specimen.

BEDFORD, MA, Nov. 14, 2013 /CNW Telbec/ - BEDFORD, Mass., Nov. 14, 2013 /CNW/ - Hologic, Inc. (Hologic or the Company) today announced that Health Canada has approved its 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 or 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 is designed to detect 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.

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

About the Hologic Aptima HPV Assay:

Hologic's Aptima HPV assay is designed to detect messenger RNA overexpressed from the E6 and E7 viral oncogenes in 14 high-risk HPV types associated with cervical cancer and precancerous lesions. Cervical cancer is one of the most common cancers among women in the world, and HPV is responsible for more than 99% of all cervical cancers.^1-3

The Aptima HPV test is performed with Hologic's ThinPrep liquid cytology specimens, which are routinely used for Pap testing. Other Hologic diagnostic tests that use ThinPrep specimens, and are cleared by Health Canada for use on the Panther system include the Aptima Combo 2 assay for chlamydia and gonorrhea, and the Aptima Trichomonas vaginalis assay.

The Aptima HPV assay has been approved for two uses:

• To screen women 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy.
• To use adjunctively with cervical cytology to screen women 30 years and older to assess the presence or absence of high-risk HPV types.

The Aptima HPV assay was CE-marked in 2008 and received Health Canada approval earlier this year for use on Hologic's high-throughput Tigris testing platform.

For more information about Hologic's molecular diagnostic technology, please visit www.hologic.com or www.gen-probe.com.

About Hologic, Inc.:

Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products, with an emphasis on serving the healthcare needs of women. The Company operates four core business units focused on breast health, diagnostics, GYN surgical and skeletal health. With a comprehensive suite of technologies and a robust research and development program, Hologic is committed to improving lives. The Company is headquartered in Massachusetts.

Hologic, Aptima, Aptima Combo 2, Panther, ThinPrep, Tigris 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 Media Release may contain forward-looking information that involves risks and uncertainties, including statements about Hologic, Inc. and our products. There can be no assurance these products will achieve the benefits described herein and that such benefits will be replicated in any particular manner with respect to an individual patient. Hologic disclaims any obligation to release publicly any updates or revisions to the data or statements presented herein or 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.

_____________________________
^1 Doorbar, J. 2006. Molecular biology of human papillomavirus infection and cervical cancer. Clin Sci (Lond). 110(5):525-41.
^2 Monsonego J., F.X. Bosch, P. Coursaget, J.T. Cox, E. Franco, I. Frazer, R. Sankaranarayanan, J. Schiller, A. Singer, T.C. Wright Jr, W. Kinney, C.J. Meijer, J. Linder, E. McGoogan, and C. Meijer. 2004. Cervical cancer control, priorities and new directions. Int J Cancer. 108(3):329-33. Erratum in: Int J Cancer. 108(6):945.
^3 Walboomers, J. M., M.V. Jacobs, M.M. Manos, F.X. Bosch, J.A. Kummer, K.V. Shah, P.J. Snijders, J. Peto, C. J. Meijer, N. Munoz.1999. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 189:12-19.

 

SOURCE: Hologic, Inc.

http://www.hologic.com