PD-L1 IHC 28-8 pharmDx

FDA premarket approval P150025

PMA numberP150025

Approval

Applicant
Agilent Technologies, Inc.
Received
July 9, 2015
Decision date
October 9, 2015 (APPR)
Supplements
17, latest September 11, 2026

Official FDA PMA record

Approval order statement

APPROVAL FOR THE PD-L1 IHC 28-8 PHARMDX. THIS DEVICE IS INDICATED FOR THE FOLLOWING:1) PD-L1 IHC 28-8 PHARMDX IS A QUALITATIVE IMMUNOHISTO-CHEMICAL ASSAY USING MONOCLONAL RABBIT ANTI-PD-L1, CLONE 28-8 INTENDED FOR USE IN THE DETECTION OF PD-L1 PROTEIN IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC) TISSUE USING ENVISION FLEX VISUALIZATION SYSTEM ON AUTOSTAINER LINK 48; 2) PD-L1 PROTEIN EXPRESSION IS DEFINED AS THE PERCENTAGE OF TUMOR CELLS EXHIBITING POSITIVE MEMBRANE STAINING AT ANY INTENSITY; AND3) PD-L1 EXPRESSION AS DETECTED BY PD-L1 IHC 28-8 PHARMDX IN NON-SQUAMOUS NSCLC MAY BE ASSOCIATED WITH ENHANCED SURVIVAL FROM OPDIVO (NIVOLUMAB).