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PD-L1 Non-Lung (Atezolizumab), IHC
Test Code94047
CPT Codes
88360
Preferred Specimen
Formalin-fixed, paraffin-embedded tissue block submitted in IHC specimen transport kit
Other Acceptable Specimens
Minimum: 5 unstained, positively charged slides
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.
Shipping refrigerated acceptable; Shipping frozen unacceptable
Shipping refrigerated acceptable; Shipping frozen unacceptable
Transport Temperature
Room temperature
Specimen Stability
Formalin-fixed tissue block
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Slides
Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Slides
Room temperature: 30 days
Refrigerated: 30 days
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Baked or melted slides • Previously stained slides • Cytospins • Tissue types other than bladder cancer specimens • Cytology cell block • Decalcified specimens • Fixative other than formalin
Methodology
Immunohistochemical Stain
Setup Schedule
Set up: Mon-Fri; Report available: 3-5 days
Reference Range
See Laboratory Report
Clinical Significance
PD-L1 IHC SP142 may be indicated as an aid in identifying patients for treatment with TECENTRIQ® (Atezolizumab). 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 with Interpretation.
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, 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 with Interpretation.
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, 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
