The study, SHENCCAST II, is a major cervical cancer screening trial including more than 10,000 women that is being conducted in China to evaluate the performance of HPV assays, among other endpoints. A preliminary analysis of data from 5,043 patients showed the Cervista HPV HR test performed as follows: Overall HPV positivity for this cohort was 12.2 percent for the Cervista HPV HR test and 14.6 percent with the hc2 test.
“These data further validate use of the Cervista HPV HR test as a viable method for identifying patients at risk of developing or harboring cervical neoplasia,” said Jerome Belinson, MD, Professor of Surgery, Section of Gynecologic Oncology at the Cleveland Clinic and President of Preventive Oncology International. “It’s the combination of sensitivity and specificity that best describes a test’s diagnostic value. Our analysis clearly showed that both of these methods performed well and with similar accuracy.”
About the Hologic Cervista(R) HPV Tests
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.
About Human Papillomavirus and Cervical Cancer
About Hologic, Inc.
Forward Looking Statement Disclaimer
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(R) and hc2(R) are Qiagen trademarks.
CONTACT: Olga Karagiannis, Hologic, Inc., +1-781-761-7069,
olga.karagiannis@hologic.com, or Anne Rivers, Hologic, Inc.,
+1-508-263-8765, anne.rivers@hologic.com
Web site: http://www.hologic.com/
