1. What: Sonic Healthcare USA Anatomic Pathology offers FDA-approved, indication specific PD-L1 stains for melanoma, bladder, lung, breast, gastro-esophageal, cervical, and head & neck cancers.
2. How: Qualitative immunohistochemistry assessment of PD-L1 protein in FFPE tumor tissue. Stains are manually scored by pathologists trained by the vendor. The percentage of tumor and immune cell staining is reported following the FDA- approved protocol.
3. Orders: A requisition will be provided to submit the orders. Select the appropriate PD-L1 order for the tumor type. Contact Customer Service for a requisition.
4. Submit: Either send unstained, charged slides (4 total) or send a tumor block. Blocks will be returned. See “PD-L1 specimen requirements” (separate document) for specific cutting instructions.
5. Stains are performed on an invasive tumor, either primary or metastatic. An H&E stained slide is reviewed by a pathologist to con rm the target area containing tumor. The duration of fixation, using 10% neutral-buffered formalin, is presumed to be no less than 6 hours and no more the 72 hours. Minimum 50 tumor cells recommended.
6. Time: The TAT is usually 72 hrs.
7. Results: Pathology report will be available to the referring Sonic facility based on their usual reporting preference.