Study evaluating clinical performance of Cervista(R) HPV HR presented at AOGIN
Source: www.prnewswire.com Author: press release Hologic, Inc. (Hologic or the Company), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced that interim data from the first large-scale independent evaluation of clinical performance of Cervista® HPV HR compared to Hybrid Capture 2 (hc2), were presented at the 4th Biennial Meeting of AOGIN (Asia-Oceanic Research Organization in Genital Infection and Neoplasia) in New Delhi, India on March 26-28, 2010. 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 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. For histologically confirmed CIN 2 or more severe lesions, the Cervista HPV HR test showed a sensitivity of 90.7 percent and a specificity of 90.2 percent. For the hc2 test, sensitivity and specificity were 94.7 percent and 87.9 percent, respectively. While the Cervista HPV HR test demonstrated improved specificity and the hc2 test yielded higher sensitivity, a statistical analysis of overall test accuracy that plots sensitivity and specificity found the two methods were clinically equivalent (area under the ROC [...]