BioCentury
ARTICLE | Clinical News

14-type high-risk HPV test: Final post-marketing study data

July 19, 2010 7:00 AM UTC

Final data from the Chinese post-marketing SHENCCAST II trial in 8,435 women showed that sensitivity for the identification of confirmed cervical intraepithelial neoplasia grade 2+ (CIN2+) was statistically equivalent for Cervista HPV HR test and the Digene HPV Test from Qiagen N.V. (Xetra:QIA; NASDAQ:QGEN, Venlo, the Netherlands) (92.9% vs. 95.6%). Cervista did significantly improve specificity vs. Digene (91.1% vs. 88.6%, p<=0.05), but a statistical analysis of overall test accuracy showed that the tests were clinically equivalent. Data were presented at the International Papillomavirus meeting in Montreal. ...