PD-L1 28-8 pharmDx by Immunohistochemistry with Interpretation, nivolumab (OPDIVO)
Ordering Recommendation

FDA-approved complementary codiagnostic test that aids in predicting response to nivolumab (OPDIVO) treatment for patients with nonsquamous non-small cell lung cancer (NSCLC), melanoma, urothelial carcinoma, or head and neck squamous cell carcinoma (HNSCC). Refer to the PD-L1 Testing Algorithm for more information.

28-8 IP
1-5 days
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
ARUP Consult®
Disease Topics
Specimen Required
Patient Preparation
Tumor tissue. 
Specimen Preparation
Formalin fix (10 percent neutral buffered formalin) and paraffin embed specimen. Protect paraffin block and/or slides from excessive heat. Transport tissue block or 5 unstained (3- to 5-micron thick sections), positively charged slides in a tissue transport kit (ARUP supply #47808 recommended but not required), available online through eSupply using ARUP Connector contact ARUP Client Services at (800) 522-2787. (Min: 3 slides) If sending precut slides, do not oven bake. 
Storage/Transport Temperature
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months. 
Unacceptable Conditions
Paraffin block with no tumor tissue remaining; specimens fixed in any fixative other than 10 percent neutral buffered formalin. 
Include surgical pathology report and indicate tissue site with the test order. For additional technical details, please contact ARUP Client Services at (800) 522-2787. 
Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable 
Reference Interval
Interpretive Data
Refer to report.

This test code includes pathologist interpretation.
Hotline History
Component Test Code*Component Chart NameLOINC
2012108PD-L1 Client Block ID57723-9
2013285PDL1 Tissue Source31208-2
2013286Adequacy of Specimen
2013687Percent of PD-L1 Positive Tumor Cells
2013689PD-L1 28-8 by IHC Result
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  • BMS
  • Bristol-Myers Squibb
  • PD-L1
  • PDL1