===== PD-L1 IHC BIOMARKER – NON-REPORTABLE ===== **Comment:** PD-L1 was requested; however, the result is **Non-Reportable** for the following reason(s): * **Fixation Requirements:** Validated only for tissue fixed in 10% NBF for 12–72 hours. * **Cellularity:** Sample lacks the minimum requirement of **100 viable tumor cells**. * **Pre-analytical Interference:** Incompatible with: * Non-NBF fixatives or sub-optimal fixation times. * Extended ischemic time. * Decalcification or microwave treatment. * **Assay Specificity:** PD-L1 assays (22C3, 28-8, SP263) are **not interchangeable** and cannot be substituted. * **Clinical Indications:** * **Unknown Primary:** Primary site must be known to determine the appropriate scoring system. * **Provincial Approval:** Testing is restricted to cancer types approved for funding in Alberta. **Resources:** * [[https://www.albertahealthservices.ca/assets/programs/ps-1025651-drug-benefit-list.pdf|AHS Drug Benefit List]] * [[https://www.pdl1alberta.com|PD-L1 Alberta Portal]] ---- **Test ID:** %%MDHPDL1NONREPORTABLE%% {{:MDHPDL1NONREPORTABLE.docx|MDHPDL1NONREPORTABLE}}