CLN Article

Roche Receives FDA Clearance for Cervical Pre-Cancer Detection Test

Regulatory Roundup: June 2017

The Food and Drug Adminis­tration has cleared Roche’s CINtec Histology test based on the results of the CERTAIN (Cervical Tissue Adjunctive Analysis) study. This test is the only clinically validated p16 biomarker test that, when used in conjunction with hematoxylin and eosin (H&E) staining, helps pathologists determine which women should receive treatment for cervical pre-cancer. When a cervical tissue biopsy is taken as a result of an abnormal cervical cancer screening result, the CINtec Histology enables conclusive visual confirmation of the presence or absence of pre-cancerous lesions. The World Health Organiza­tion, the College of American Patholo­gists, and the American Society for Colposcopy and Cervical Pathology all recommend the use of p16 immunohistochemistry to improve the detection of pre-cancerous­ cervical disease. 

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