Shots:

• The approval is based on IMPACT trial- which enrolled ~ 35-000 women to clinically validate CINtec PLUS Cytology as a triage test in various screening scenarios. Publication of the full study findings is pending
• The approval gives laboratories access to the complete Roche Cervical Cancer Portfolio in the US- including the cobas HPV Test- CINtec PLUS Cytology- and CINtec Histology. The approval allows the test to be set as triage for positive cobas HPV tests run on cobas 6800/8800 Systems in primary screening or co-testing programs
• The CINtec PLUS Cytology test runs on the BenchMark ULTRA IHC/ISH system and is performed using the same sample that is used for HPV or liquid-based Pap cytology tests. The assay detects the simultaneous presence within a single cell of the two biomarkers (p16 and Ki-67) and a positive result signals that a woman is at risk for disease

­ Ref: Roche | Image: Roche