PDL1 in Alberta

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