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
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
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
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
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.
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