PD-L1 28-8 pharmDx by Immunohistochemistry with Interpretation, nivolumab (OPDIVO)
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
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.
Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.
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.
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
Refer to report.
This test code includes pathologist interpretation.
|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|
- Bristol-Myers Squibb