PD-L1 by IHC, Opdivo®

Casandra

Casandra Test Code LC67810Version 1 (DRAFT)

Performing Lab

Lab LabcorpLab Test ID N/ACPT Code 88360

PD-L1 by IHC, Opdivo®

Also known as: PD-L1 IHC 28-8 pharmDx

Clinical Use

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Use

The PD-L1 by IHC test, using the Dako PD-L1 28-8 pharmDx™ kit, is intended for the detection of PD-L1 expression in formalin-fixed, paraffin-embedded tissue samples. This can assist in the assessment of eligibility for Opdivo® (nivolumab) treatment in patients with specific cancer types, including non-small-cell lung cancer (NSCLC), urothelial carcinoma (bladder cancer), and head and neck squamous cell carcinoma (HNSCC). The test is utilized as a qualitative assay in oncology to determine the presence of the PD-L1 protein, which can indicate the likelihood of a positive response to immunotherapy with Opdivo®.

Special Instructions

This test requires that the tissue sample is fixed in 10% neutral buffered formalin for no more than 72 hours before embedding in paraffin. Use of alternative fixatives has not been validated and may cause incorrect results.

Limitations

The test can produce false-negative results if the tissue sample is fixed with chemicals other than 10% neutral buffered formalin or if the fixation duration exceeds 72 hours. The test is also limited to specific cancer types and is not validated for tumor types other than non-small-cell lung cancer (NSCLC), bladder cancer, and head and neck squamous cell carcinoma (HNSCC). Sufficient tissue sample size and quality are critical for accurate results; insufficient tissue or incompatible tumor types may result in test rejection.

Test Details