Hologic, Inc. Release: Final Results of First Independent Study Highlight Clinical Effectiveness of Cervista HPV HR Test

BEDFORD, Mass., July 7 /PRNewswire-FirstCall/ -- Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading women's healthcare company, today announced that final data analysis from the first large-scale independent evaluation of clinical performance of Cervista® HPV HR compared to Hybrid Capture 2 (hc2), were presented in Montreal, Canada, at the 26th International Papillomavirus Conference. Cervista HPV HR is a diagnostic test for the detection of 14 high-risk human papillomavirus (HPV) types.

The study, SHENCCAST II, is a major cervical cancer screening trial conducted in China to evaluate the performance of HPV assays, among other endpoints. The final analysis of this arm of the study, which included 8,435 patients, showed sensitivity for the identification of confirmed CIN2 or greater was statistically equivalent for the Cervista HPV HR test (92.9%) and hc2 (95.6%). However, Cervista HPV HR demonstrated a statistically significant improvement in specificity compared to hc2 (91.1% vs 88.6%; p = <.05). Overall HPV positivity in the study population was 11.1 percent for the Cervista HPV HR test and 13.6 percent with the hc2 test. Cervista HPV HR also had a significantly lower HPV positivity rate (6%) for patients with normal cytology compared to hc2 (7.9%).

While the Cervista HPV HR test demonstrated improved specificity and similar sensitivity, a statistical analysis of overall test accuracy that plots sensitivity and specificity found the two methods were clinically equivalent (area under the ROC curves).

"We had presented preliminary results from our trial at AOGIN in March. These data further validate the efficacy of the Cervista HPV HR test for identifying patients at risk of developing or harboring cervical neoplasia," said Jerome Belinson, M.D., Professor of Surgery, Section of Gynecologic Oncology at the Cleveland Clinic and President of Preventive Oncology International. "Our analysis clearly showed that both of these methods performed well and with similar overall accuracy."

"The conclusions of this study should not be under estimated. This is the first head-to-head clinical study to date comparing clinical performance of Cervista HPV HR and Hybrid-Capture 2," said Edward Evantash, M.D., Medical Director and Vice President of Medical Affairs at Hologic. "These clinical data, in combination with its specific advantages in HPV testing, further demonstrate the additional value Cervista HPV brings to overall patient care."

About the Hologic Cervista® HPV Tests

The Cervista HPV HR and Cervista HPV 16/18 diagnostic tests are based on Invader® chemistry, a patented technology owned by Hologic and well established in other areas of molecular testing. Both tests are approved for use utilizing the sample collected with the ThinPrep® Pap Test, offering additional convenience for the healthcare provider.

Approved by the U.S. Food and Drug (FDA) Administration in March 2009, Cervista is the first new HPV assay in over a decade. It is the only FDA-approved test to feature an internal control, which allows confidence that a negative result is not the result of an insufficient sample. In addition, Cervista requires a sample size that is half that of the older competitor's test, which should result in fewer patient call backs. The assay also reduces lab processing time while providing some additional workflow advantages.

The Cervista HPV HR test screens for 14 of the most common disease-causing strains of HPV. The Cervista 16/18 test is the only HPV test available to diagnose for strains 16 and 18, which account for more than 70 percent of all cervical cancers.

About Human Papillomavirus and Cervical Cancer

HPV is the most common sexually-transmitted disease (STD) in the United States and is recognized as the cause of most cervical cancers. To help prevent the onset of disease, the American College of Obstetrics and Gynecology (ACOG) suggests routine Pap and HPV testing for women over the age of 30 to identify women most likely to develop cervical cancer.

About Hologic, Inc.

Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic's core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia, permanent contraception, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging and molecular diagnostic products including HPV and reagents for a variety of DNA and RNA analysis applications. For more information, visit www.hologic.com.

Forward Looking Statement Disclaimer

This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the use of the Cervista HPV tests. There can be no assurance that the tests 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 Cervista HPV tests can only be determined on a case-by-case basis depending on the particular circumstances of the test 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. Certain factors that could adversely affect the Company's business and prospects are described in Hologic filings with the Securities and Exchange Commission.

Hologic, Cervista and ThinPrep are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.Hybrid Capture® and hc2® are Qiagen trademarks.

SOURCE Hologic, Inc.