Ordering Recommendation

FDA-approved companion diagnostic testing to aid in predicting the overall survival benefit from nivolumab (OPDIVO) in combination with ipilimumab (YERVOY) as first-line therapy for patients with non-small cell lung carcinoma. FDA-approved complementary codiagnostic test that may aid in predicting response to nivolumab (OPDIVO) treatment for patients with nonsquamous non-small cell lung cancer (NSCLC), urothelial carcinoma, or head and neck squamous cell carcinoma (HNSCC). Refer to the PD-L1 Testing Algorithm for more information.

New York DOH Approval Status

This test is New York state approved.

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 Connect™ or 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

Specimens with fewer than 100 viable tumor cells. Specimens fixed in any fixative other than 10 percent neutral buffered formalin. Decalcified specimens.


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.
If multiple specimens (blocks or slides) are sent to ARUP, they must be accompanied by one of the following: an order comment indicating that the ARUP pathologist should choose the specimen most appropriate for testing (e.g., "Choose best block"), or individual orders for each sample submitted. A Pathologist Block Selection Fee (ARUP test code 3002076) will be added to orders that utilize the first option. If multiple specimens are sent to ARUP without a request for pathologist block/slide selection or individual orders, they will be held until clarification is provided.


Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable






1-5 days

Reference Interval

Interpretive Data

Refer to report.

Compliance Category



This test code includes pathologist interpretation.

Hotline History


CPT Codes



Component Test Code* Component Chart Name LOINC
2012108 PD-L1 Client Block ID 94736-6
2013285 PDL1 Tissue Source 31208-2
2013286 Adequacy of Specimen
2013687 Percent of PD-L1 Positive Tumor Cells
2013689 PD-L1 28-8 by IHC Result 55229-9
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.


  • BMS
  • Bristol-Myers Squibb
  • PD-L1
  • PDL1
PD-L1 28-8 pharmDx by Immunohistochemistry with Interpretation, nivolumab (OPDIVO)