Hologic's APTIMA HPV Assay and APTIMA HPV 16 18/45 Genotype Assay Receive Canadian Regulatory Approval

Hologic's APTIMA HPV Assay and APTIMA HPV 16 18/45 Genotype Assay Receive 
Canadian Regulatory Approval 
Nucleic acid amplified tests used to detect high-risk strains of human 
papillomavirus 
BEDFORD, Mass., April 4, 2013 /CNW/ - Hologic, Inc. announced today that 
Health Canada has granted medical device licenses for Hologic's APTIMA HPV and 
APTIMA HPV 16 18/45 genotype assays. Both assays are in vitro nucleic acid 
amplification tests (NAATs) that are designed to detect high-risk strains of 
the human papillomavirus (HPV) that are associated with cervical cancer and 
precancerous lesions. HPV is among the most common sexually-transmitted 
infections (STIs) in Canada and worldwide. The tests have been approved to run 
on Hologic's fully automated, high-throughput TIGRIS instrument system. 
The APTIMA HPV assay is designed to detect 14 high-risk HPV types associated 
with cervical cancer and precancerous lesions. The APTIMA HPV 16 18/45 
genotype assay is approved for genotyping HPV types 16, 18 and/or 45, which 
are associated with approximately 80% of all invasive cervical cancers 
worldwide. Detecting the specific HPV types 16, 18 and/or 45 provides 
healthcare professionals with additional information regarding a patient's 
risk of subsequently developing cervical cancer. Both assays can be performed 
using Hologic's ThinPrep liquid cytology specimens collected for routine pap 
tests as well as Hologic's APTIMA cervical specimen collection and transport 
kit. 
"Most HPV infections clear up on their own, so it's important to identify 
those persistent, high-risk infections that are most likely to lead to 
cervical cancer," said Tom Wright, MD, Professor of Pathology and Cell Biology 
at the Columbia University Medical Center. "In numerous clinical studies 
involving approximately 45,000 women, the APTIMA HPV assay has consistently 
shown similar sensitivity and better specificity than the most frequently used 
DNA-based test. This means the APTIMA HPV assay is highly accurate in 
detecting cervical disease, but is less likely to raise false alarms that can 
result in unnecessary medical procedures." 
Health Canada's approval of the APTIMA HPV and HPV 16 18/45 genotype assays is 
based on data from the CLEAR (Clinical Evaluation of APTIMA HPV RNA) trial, 
which analyzed approximately 11,000 women undergoing routine Pap testing at 18 
US clinics. In the study, the APTIMA HPV assay showed similar sensitivity for 
the detection of cervical disease as a Health Canada-approved, DNA-based test. 
However, the specificity of the APTIMA HPV assay was higher than that of the 
DNA-based test, and this advantage was statistically significant. 
About the Hologic APTIMA HPV and APTIMA HPV 16 18/45 Genotype Assays 
The Hologic APTIMA HPV assay has been approved for two uses: 


    --  To screen patients with atypical squamous cells of undetermined
        significance (ASC-US) cervical cytology results in order to
        determine the need for referral to colposcopy.
    --  To be used 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 16 18/45 genotype assay is intended to test specimens from 
women with APTIMA HPV assay positive results and is approved for two uses:
    --  To be used adjunctively with the APTIMA HPV assay in women aged
        30 years and older in combination with cervical cytology to
        assess the presence or absence of specific high?risk genotypes
        16, 18 and/or 45.
    --  To be used adjunctively with the APTIMA HPV assay in women aged
        21 years or older with ASC?US cervical cytology results to
        assess the presence or absence of specific high?risk HPV
        genotypes 16, 18 and/or 45. The results of this test are not
        intended to prevent women from proceeding to colposcopy.

About Hologic

Hologic, Inc. is a leading developer, manufacturer and supplier of premium 
diagnostic products, medical imaging systems, and surgical products. 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. 
For more information, visit www.hologic.com.

Hologic, APTIMA, ThinPrep and TIGRIS 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 our expectations or any change in events, 
conditions or circumstances on which any such data or statements are based.

 
________________________________________________________________________________________________________________________
_____________________________________________________________________________________________
|Contact:                                                                                                         |     


                                                                                          |
|_________________________________________________________________________________________________________________|_____
______________________________________________________________________________________________|
|                                                                                                                 |      
                                                                                          |
|_________________________________________________________________________________________________________________|_____
______________________________________________________________________________________________|
|Marianne McMorrow                                                                                                
|Julie Cole                                                                                         |
|_________________________________________________________________________________________________________________|_____
______________________________________________________________________________________________|
|Global Marketing and Advertising Publicist                                                                       
|Manager, Marketing Communications                                                                  |
|_________________________________________________________________________________________________________________|_____
______________________________________________________________________________________________|
|marianne.mcmorrow@hologic.com|julie.cole@hologic.com|
|_________________________________________________________________________________________________________________|_____
______________________________________________________________________________________________|
|781.999.7723                                                                                                     
|858.410.8986                                                                                       |
|_________________________________________________________________________________________________________________|_____
______________________________________________________________________________________________| 
http://www.hologic.com 
SOURCE: Hologic, Inc. 
To view this news release in HTML formatting, please use the following URL: 
http://www.newswire.ca/en/releases/archive/April2013/04/c2849.html 
CO: Hologic, Inc.
ST: Massachusetts
NI: HEA MTC  
-0- Apr/04/2013 20:30 GMT
 
 
Press spacebar to pause and continue. Press esc to stop.