Clinical performance data of Cervista HPV HR presented at International Papillomavirus Conference

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."