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:

Test ID: MDHPDL1NONREPORTABLE

MDHPDL1NONREPORTABLE