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-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN),melanoma, and esophageal squamous cell carcinoma (ESCC) tissues using EnVision FLEX visualization system on Autostainer Link 48.

PD-L1 protein expression 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-small cell lung cancer (NSCLC) - companion diagnostic indication

PD-L1 expression (≥ 1% tumor cell expression) as detected by PD-L1 28-8 pharmDx in NSCLC is indicated as an aid in identifying NSCLC patients for treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab).

Esophageal squamous cell carcinoma (ESCC) - companion diagnostic indication

PD-L1 expression (≥ 1% tumor cell expression) as detected by PD-L1 28-8 pharmDx in ESCC is 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).

Non-squamous non-small cell lung cancer (nsNSCLC)

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)

Melanoma

Positive PD-L1 status as determined 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.

Squamous cell carcinoma of the head and neck (SCCHN)

PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in SCCHN may be associated with enhanced survival from OPDIVO® (nivolumab).

PD-L1 IHC 28-8 pharmDx Kit

The kit includes reagents required for the immunohistochemical staining (except wash buffer and Hematoxylin), 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.