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Hologic Comments on Important Cervical Cancer Screening Study Published in the American Cancer Society Journal, Cancer Cytopathology
Date:4/16/2015

BEDFORD, Mass., April 16, 2015 /PRNewswire/ -- Hologic, Inc. (NASDAQ: HOLX) today commented on an important cervical cancer screening studyi published on-line this week in Cancer Cytopathology, a peer-reviewed journal of the American Cancer Society.

The study, by researchers at Quest Diagnostics and the University of Pittsburgh Medical Center, supports current consensus guidelinesii for cervical cancer screening, which recommend that women 30-65 years of age be co-tested with both Pap and human papillomavirus (HPV) tests.  Pap tests identify cellular abnormalities, while HPV tests identify the presence of the virus that causes most cervical cancers.

Hologic issued the following statement on the study:

As cervical cancer screening approaches are being debated, important real-world patient data from the largest U.S. retrospective cervical cancer screening study ever completed show that HPV-only screening missed more cervical cancers than Pap testing alone or Pap-plus-HPV co-testing.

In the new study, which reviewed screening results from approximately 8.6 million women, 18.6% of women with confirmed cervical cancer received a negative test result when tested only with an HPV assay.  In contrast, 5.5% of women with cancer who were co-tested received a negative test result, representing an approximate three-fold improvement in the cancer detection rate.  Moreover, the study also demonstrated that co-testing offered superior detection of a pre-cancerous condition called CIN3.

Hologic believes the study results support the current consensus guidelines for cervical cancer screening, which recommend that women between 30 and 65 years of age be screened with both Pap and HPV tests, and that co-testing remains the preferred diagnostic standard for cervical cancer detection in women of this age group.

"At a time when the best screening approach for millions of women is being debated, it is important to remember that the Pap test is the most successful cancer screening test in history," said Edward Evantash, M.D., Medical Director and Vice President of Medical Affairs, Hologic.  "The introduction of the Pap test decades ago has significantly reduced cervical cancer mortalityiii, and as the adoption of co-testing has increased, cervical cancer rates have declined further.iv,v,vi  We should not reverse the progress that has been made.  As this significant study demonstrates, healthcare professionals should continue to rely on both Pap and HPV tests to safeguard their patients' health, recognizing that HPV-only screening will leave cancers undetected, and therefore untreated." 

Hologic is committed to advancing women's health and providing valuable cervical cancer diagnostics.  The Company offers a full range of diagnostic solutions proven to reduce false negatives and false positives, giving healthcare professionals the confidence to identify patients at risk for developing cancer, while minimizing unnecessary interventions.

About HologicHologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. The Company's core business units focus on diagnostics, breast health, GYN surgical, and skeletal health. With a unified suite of technologies and a robust research and development program, Hologic is dedicated to The Science of Sure. For more information on Hologic, visit www.hologic.com.

Forward-Looking StatementsThis press release may contain forward-looking information that involves risks and uncertainties, including statements about approaches to cervical cancer screening.  There can be no assurance these approaches will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient.  The actual effect of the use of the approaches 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 any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.

Hologic and The Science of Sure are trademarks and/or registered trademarks of Hologic, Inc. in the United States and/or other countries.

ContactMichael Watts
Vice President, Investor Relations and Corporate Communications
(858) 410-8588
michael.watts@hologic.com  ___________________________i Blatt AJ et al, Cancer Cytopathology, 2015 Apr 10. doi: 10.1002/cncy.21544, [Epub ahead of print].ii Saslow D et al., Journal of Lower Genital Tract Disease, Volume 16, Number 3, 2012.iii American Cancer Society. What Are the Key Statistics About Cervical Cancer? 2011. Available at: http://www.cancer.org/Cancer/CervicalCancer/DetailedGuide/cervical-cancer-key-statisticsiv Number of New Cases and Deaths per 100,000 people (all races, females), age-adjusted. http://seer.cancer.gov/statfacts/html/ld/cervix.html. v Tatsas et al. Am J Clin Path. 2012; 138: 223-229.vi Bekker et al. Am J Clin Path. 2013; 139: 259-262.


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