|
|
| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
PD-L1 SP263 FDA FOR NSCLC
MessageThe VENTANA PD-L1 (SP263) assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP263 intended for use in the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue on a VENTANA BenchMark ULTRA instrument.
Test Code
LAB6401
CPT Codes
88360x1
Preferred Specimen
A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred specimen type
or
One (1) unbaked, unstained slide for H&E staining (required) and two to three (2-3) positively charged unstained slides (all cut at 4-5 microns) for each test/antibody ordered
Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
For PD-L1 SP263 evaluation, tissue submitted must have ≥50 viable tumor cells present.
or
One (1) unbaked, unstained slide for H&E staining (required) and two to three (2-3) positively charged unstained slides (all cut at 4-5 microns) for each test/antibody ordered
Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
For PD-L1 SP263 evaluation, tissue submitted must have ≥50 viable tumor cells present.
Instructions
Use cold pack for transport. Make sure cold pack is not in direct contact with specimen.
Methodology
IHC
Report Available
48 hours
Clinical Significance
PD-L1 (SP263) is indicated as an aid in identifying patients with Stage II to IIIA NSCLC, whose tumors have PD-L1 expression on ≥ 1% of tumor cells (TC) of any intensity, for treatment with TECENTRIQ® (atezolizumab).
Performing Laboratory
Neogenomics Laboratories
