Strong Clinical Performance

Hologic, Inc is dedicated to serving the healthcare needs of women and announced the final results from an independent Trial that highlights the clinical effectiveness of Cervista® HPV HR.

The SHENCCAST II study is the first and only large-scale independent evaluation of clinical performance of Cervista® HPV HR compared to Hybrid Capture® 2 (hc2). Data from the completed study of over 8400 women were presented at the 26th International Papillomavirus Conference in Montreal.

The HPV positivity rate in women with normal cytology was 6.0% when tested with Cervista HPV HR, lower than the 7.9% positive rate with hc2; sensitivity for ‡ CIN2 was statistically equivalent for the Cervista HPV HR test, 92.9% (88.8-95.9) and hc2, 95.6% (92.0-97.9); Cervista HPV demonstrated a statistically significant improvement in specificity compared to hc2 with 91.1% (90.5-91.7) vs 88.6% (87.9-89.3) (p = <.05); and a statistical analysis of overall test accuracy that plots comparative sensitivity and specificity found the two methods were clinically equivalent.

In a large and demographically diverse prospective clinical trial, Cervista® HPV demonstrated clear clinical utility. The study’s clinical findings found: sensitivity of the Cervista HPV HR test for detection of ‡ CIN2 among women with ASC-US cytology was 92.8% (84.1-96.9) and the NPV was 99.1% (98.1-99.6); sensitivity for detection of ‡ CIN3 among women with ASC-US cytology was 100% (85.1-100) and the NPV was 100% (99.4-100); and 16/18 genotyping test sensitivity of ‡ CIN2 was 68.8 (56.6-78.8) and NPV was 96.0% (93.9-97.4).

16/18 genotyping test sensitivity of ‡ CIN3 was 77.3 (56.6-89.9) and NPV was 99.0% (97.7-99.6).