Roche Wins CFDA Approval for CINtec PLUS Cytology Test

Switzerland-based Roche has gained approval from the China Food and Drug Administration for its CINtec PLUS Cytology test, intended to enhance the detection of human papillomavirus.

The approval was based on a study that demonstrated “greater overall performance of combined sensitivity and specificity” of the CINtec PLUS Cytology test in determining which women are more susceptible to developing cervical cancer versus pap cytology, according to the company.

The test is now available in China, Europe, Asia, Latin America and Canada. — Anisa Jibrell