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.

Mnemonic
28-8 IP
Methodology

Immunohistochemistry

Performed

Mon-Fri

Reported

1-5 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

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.

Remarks

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.

Stability

Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Reference Interval
Interpretive Data

Refer to report.

Compliance Category

FDA

Note

This test code includes pathologist interpretation.

Hotline History
N/A
CPT Codes

88342

Components
Component Test Code* Component Chart Name LOINC
2012108 PD-L1 Client Block ID 57723-9
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
* 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.
Aliases
  • BMS
  • Bristol-Myers Squibb
  • PD-L1
  • PDL1
PD-L1 28-8 pharmDx by Immunohistochemistry with Interpretation, nivolumab (OPDIVO)