Anti pd l1 22c3 pharmdx kit

Ninety-nine different FFPE NSCLC tissue samples (comprised of 25 internally sourced whole tissue blocks and 74 TMA cores from the LC10011b TMA block procured from US Biomax, Inc.) were sectioned at 4 microns and stained for PD-L1 (22C3) using the clinically verified class I IHC IVD from Dako (anti-PD-L1 [22C3] pharmDx kit: SK006). The PD-L1(23C3) IVD was performed on the Dako Autostainer Link 48 platform (Agilent Technologies, Santa Clara, CA) according to the manufacturer’s instrument specific labeling protocol.

Tissues from 66 NSCLC samples (comprised of 20 internally sourced whole tissue blocks and 46 TMA cores from an internally sourced TMA block) were formalin-fixed, paraffin-embedded (FFPE), sectioned at 4 microns, and stained for PD-L1 (22C3) using the clinically verified class I IHC IVD from Dako (anti-PD-L1 [22C3] pharmDx kit: SK006). These 66 stained samples were used to assess the sensitivity, specificity, and accuracy of the digital PD-L1 assay. To assess for the precision of the digital assay, a subset of 4 samples with a range of PD-L1 staining intensities were chosen to have additional serial sections cut and stained for PD-L1 (22C3) on two subsequent staining days, one day stained within the same laboratory and the other day stained at an outside laboratory. The PD-L1 (22C3) IVD was performed on the Dako Autostainer Link 48 platform (Agilent Technologies, Santa Clara, CA) according to the manufacturer’s instrument specific labeling protocol.