Hologic Inc 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 to 28.
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 curves).
"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."
"Hologic brought the Cervista HPV HR test to market to offer clinicians and labs specific advantages in HPV testing that were not offered with the competitive product, including an internal control to guard against false negatives, a lower required sample size and various workflow advantages for labs," said Edward Evantash, MD, Medical Director and Vice President of Medical Affairs at Hologic. "We are encouraged by the real-world clinical performance of Cervista HPV HR. Cervical cancer is the most common preventable cancer among women. Through both Cervista and our ThinPrep Pap Test, we are committed to continuing to advance the science and practice of preventing cervical cancer."