PD-L1 IHC 28-8 pharmDx「ダコ」の概要

PD-L1 IHC 28-8 pharmDx is a complete kit with reagents sufficient for 50 tests (50 slides incubated with primary antibody to PD-L1 and 50 slides incubated with the corresponding Negative Control Reagent) and 15 Control Slides for use on Autostainer Link 48.

• EnVision FLEX Target Retrieval Solution, Low pH, 50x
• Peroxidase-Blocking Reagent
• Monoclonal Rabbit Anti-PD-L1, Clone 28-8
• Negative Control Reagent
• PD-L1 IHC 28-8 pharmDx Rabbit LINKER

• Visualization Reagent-HRP
• DAB+ Substrate Buffer
• DAB+ Chromogen
• DAB Enhancer
• Control Slides

Intended Use

For in vitro diagnostic use.

To measure the proportion of PD-L1 expression in cancer tissue or cells

• Indication as an aid for proper administration of nivolumab [recombinant] in non-small cell lung cancer [NSCLC] patients, head-and-neck cancer patients, and gastric cancer patients
• Indication as an aid for proper administration of nivolumab [recombinant] and ipilimumab combination in melanoma patients

It is desirable to measure PD-L1 expression by 28-8 kit in determining whether or not the following drugs can be administered.

• Nivolumab [recombinant] for patients with non-squamous NSCLC or head-and-neck cancer who have been treated with chemotherapy previously
• Combination therapy of nivolumab [recombinant] and chemotherapy for NSCLC patients or gastric cancer patients who have not been treated with chemotherapy
• Combination therapy of nivolumab [recombinant] and ipilimumab for melanoma patients

If it is not possible to measure PD-L1 expression using PD-L1 IHC 28-8 pharmDx, refer to the packaging insert of the drugs, and appropriately judge the adequacy of administration.

See the OPDIVO® product label for specific clinical circumstances guiding PD-L1 testing

References

CHECKMATE-649