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PD-L1 Non-Lung (Nivolumab), IHC
Test Code93793
CPT Codes
88360
Preferred Specimen
Formalin-fixed, paraffin embedded tissue in IHC specimen transport kit
Other Acceptable Specimens
5 unstained charged(+) slides in IHC specimen transport kit
Instructions
All FDA approved tests require FFPE tissue, other fixatives have not been validated. FFPE tissue block or unstained, positively stained slides (5 minimum) can be submitted. A pathology report which includes the paraffin block number, and both macroscopic and microscopic evaluation and diagnosis, should be sent with the specimen.
Transport Container
IHC specimen transport kit
Transport Temperature
Room temperature
Specimen Stability
Formalin-fixed paraffin embedded tissue
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Unstained charged(+) slides
Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Unstained charged(+) slides
Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable
Methodology
Immunohistochemical Stain
Setup Schedule
Set up: Mon-Fri; Report available: 4-6 days
Reference Range
See Laboratory Report
Clinical Significance
PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying patients for treatment with OPDIVO® (Nivolumab). This FDA approved test currently is applicable only to specific tumor types.
For non-FDA approved test indications or sample types, order 94007-PD-L1, IHC
For other FDA approved primary tumors, please order the following:
For Pembrolizumab:
1. NSCLC, order 93279-PD-L1 Lung (Pembrolizumab), IHC
2. Non-NSCLC, order 36260-PD-L1 Non-Lung (Pembrolizumab)
For Nivolumab:
1. Non-Squamous NSCLC or NSCLC, order 93359-PD-L1 Lung (Nivolumab), IHC
2. Non-NSCLC, order 93793-PD-L1 Non-Lung (Nivolumab)
For Atezolimab:
1. NSCLC, order 94480-PD-L1 Lung (Atezolizumab), IHC
2. Non-NSCLC order 94047-PD-L1 Non-Lung (Atezolizumab), IHC
For non-FDA approved test indications or sample types, order 94007-PD-L1, IHC
For other FDA approved primary tumors, please order the following:
For Pembrolizumab:
1. NSCLC, order 93279-PD-L1 Lung (Pembrolizumab), IHC
2. Non-NSCLC, order 36260-PD-L1 Non-Lung (Pembrolizumab)
For Nivolumab:
1. Non-Squamous NSCLC or NSCLC, order 93359-PD-L1 Lung (Nivolumab), IHC
2. Non-NSCLC, order 93793-PD-L1 Non-Lung (Nivolumab)
For Atezolimab:
1. NSCLC, order 94480-PD-L1 Lung (Atezolizumab), IHC
2. Non-NSCLC order 94047-PD-L1 Non-Lung (Atezolizumab), IHC
