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:

AHS Drug Benefit List

PD-L1 Alberta Portal

Test ID: MDHPDL1NONREPORTABLE