PD-L1 Ihc 22C3 Pharmdx

FDA premarket approval P150013 · Immunohistochemistry assay, antibody, programmed death-ligand 1

PMA numberP150013

Approval

Applicant
Agilent Technologies, Inc.
Received
April 6, 2015
Decision date
October 2, 2015 (APPR)
Supplements
34, latest September 11, 2026
Product code
PLS – Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

Official FDA PMA record

Approval order statement

APPROVAL FOR THE PD-L1 IHC 22C3 PHARMDX. THIS DEVICE IS INDICATED FOR THE FOLLOWING: PD-L1 IHC 22C3 PHARMDX IS A QUALITATIVE IMMUNOHISTOCHEMICAL ASSAY USING MONOCLONAL MOUSE ANTI-PD-L1, CLONE 22C3 ANTIBODY INTENDED FOR USE IN THE DETECTION OF PD-L1PROTEIN IN FORMALIN FIXED, PARAFFIN EMBEDDED (FFPE) NON-SMALL CELL LUNG CANCER (NSCLC) TISSUE USING ENVISION FLEX VISUALIZATION SYSTEM ON AUTOSTAINER LINK 48. PD-L1 PROTEIN EXPRESSION IS DETERMINED BY USING TUMOR PROPORTION SCORE (TPS), WHICH IS THE PERCENTAGE OF VIABLE TUMOR CELLS SHOWING PARTIAL OR COMPLETE MEMBRANE STAINING. THE SPECIMEN SHOULD BE CONSIDERED PD-L1 POSITIVE IF TPS >= 50% OF THE VIABLE TUMOR CELLS EXHIBIT MEMBRANE STAINING AT ANY INTENSITY. PD-L1 IHC 22C3 PHARMDX IS INDICATED AS AN AID IN IDENTIFYING NSCLC PATIENTS FOR TREATMENT WITH KEYTRUDA (PEMBROLIZUMAB).