FDA APPROVES APTIMA HPV ASSAY FOR USE ON HOLOGIC'S PANTHER SYSTEM
BEDFORD, Mass., July 23, 2013 /PRNewswire/ -- Hologic, Inc. (HOLX) (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 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 the FDA 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 FDA approval on the Hologic high- throughput Tigris system in 2011.
About Hologic, Inc.
Hologic, Inc. is 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. The Company operates four core business units focused on diagnostics, breast health, 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, and 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 News Release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic's Aptima assays, and its Panther system. There can be no assurance the assays and system will achieve the benefits described herein and that such benefits will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of the systems can only be determined on a case-by-case basis depending on the particular circumstances and patient 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.
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.
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SOURCE Hologic, Inc.