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

Casandra

Casandra Test Code AR27846Version 1 (DRAFT)

Performing Lab

Lab ARUP LaboratoriesLab Test ID 2013684CPT Code 88360

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

Also known as: 28-8 IP

Clinical Use

Order Test

Use

This FDA-approved companion diagnostic test helps predict overall survival benefits for patients treated with nivolumab (OPDIVO) and ipilimumab (YERVOY) as a first-line therapy in non-small cell lung carcinoma. It also aids in predicting responses to nivolumab treatment for patients with nonsquamous non-small cell lung cancer (NSCLC), urothelial carcinoma, or head and neck squamous cell carcinoma (HNSCC).

Special Instructions

Include a surgical pathology report and specify the tissue site with the test order. If multiple specimens are sent, provide an order comment or individual order for each sample. A Pathologist Block Selection Fee may apply if pathologist selection is requested.

Limitations

Testing for PD-L1 expression is not required for certain treatment settings, such as second-line treatment in non-squamous non-small cell lung cancer or treatment for squamous cell carcinoma of the head and neck. There is no established predictive value for PD-L1 expression in tumors outside of NSCLC, SCCHN, and UC. Specimens must have at least 100 viable tumor cells for evaluation. The use of this assay on decalcified tissues or those fixed in media other than 10 percent neutral buffered formalin is not validated.

Test Details

FDA Approved