PD-L1 IHC 28-8 pharmDx for Autostainer Link 48

PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemical 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), melanoma, muscle invasive urothelial carcinoma (MIUC) and esophageal squamous cell carcinoma (ESCC) tissues using EnVision FLEX visualization system on Autostainer Link 48.

PD-L1 protein expression in nsNSCLC, melanoma, MIUC and ESCC is defined as the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity as defined by the specific tumor indication interpretation guidelines in the instructions for use (IFU).

Non-squamous non-small cell lung cancer (nsNSCLC)
PD-L1 expression (≥ 1% or ≥ 5% or ≥ 10% tumor cell expression) as detected by PD-L1 IHC 28-8 pharmDx in nsNSCLC may be associated with enhanced survival from OPDIVO® (nivolumab).

Melanoma
PD-L1 expression (≥ 1% or ≥ 5% tumor cell expression) as detected by PD-L1 IHC 28-8 pharmDx in melanoma may be used as an aid in the assessment of patients for whom OPDIVO® (nivolumab) and YERVOY® (ipilimumab) combination treatment is being considered.

Muscle Invasive Urothelial Carcinoma (MIUC)
PD-L1 expression (≥ 1% tumor cell expression) as detected by PD-L1 28-8 pharmDx in MIUC is indicated as an aid in identifying MIUC patients for treatment with OPDIVO® (nivolumab).

Esophageal Squamous Cell Carcinoma (ESCC)
PD-L1 expression (≥ 1% tumor cell expression) as detected by PD-L1 28-8 pharmDx in ESCC indicated as an aid in identifying ESCC patients for treatment with OPDIVO® (nivolumab) in combination with fluoropyrimidine and platinum-based chemotherapy or OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab).

PD-L1 IHC 28-8 pharmDx kit
The kit includes reagents required for the immunohistochemical staining (except wash buffer), control slides representing different expression levels of PD-L1 protein, and detailed instructions. The kit has been tailored especially for use on Autostainer Link 48 instruments. The materials provided are sufficient for 50 tests (50 slides incubated with monoclonal rabbit antibody to PD-L1 and 50 slides incubated with the corresponding Negative Control Reagent, 100 slides in total).

PD-L1 IHC 28-8 pharmDx is subject to an exclusive trademark license to Agilent Technologies, Inc. OPDIVO® and YERVOY® are trademarks owned by Bristol-Myers Squibb.

Read more about PD-L1 IHC 28-8 pharmDx.