Hologic, a developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products, has presented interim data from the large-scale independent evaluation of clinical performance of Cervista HPV HR compared to Hybrid Capture 2 (hc2), at the 4th Biennial Meeting of AOGIN (Asia-Oceanic Research Organization in Genital Infection and Neoplasia) in New Delhi, India.
Hologic said that the Cervista HPV HR is a diagnostic test for the detection of 14 high-risk human papillomavirus (HPV) types. The Cervista 16/18 test is the only HPV test available to diagnose for strains 16 and 18, which account for more than 70% of all cervical cancers.
The study, SHENCCAST II, is a 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: Overall HPV positivity for this cohort was 12.2% for the Cervista HPV HR test and 14.6 % with the hc2 test.
For histologically confirmed CIN 2 or more severe lesions, the Cervista HPV HR test showed a sensitivity of 90.7% and a specificity of 90.2%. For the hc2 test, sensitivity and specificity were 94.7% and 87.9%, 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).
Hologic said that the Cervista test features 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 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.
Jerome Belinson, professor of surgery, section of gynecologic oncology at the Cleveland Clinic and President of Preventive Oncology International, said: “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. 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.”