What is OmniSeq PD-L1 testing?

PD-L1 D-IC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1,Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin embedded (FFPE) non-small cell lung cancer (NSCLC) tissue.

PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with Pembrolizumab (KEYTRUDA®).

This assay identifies a Tumor Proportion Score (TPS) based on the presence of a PD-L1 signal on tumor cells. Identifying PD-L1 expression on tumor cells is important to assess whether patients will respond to anti-PD-1 therapy.

The TPS falls into 1 of 3 categories which will determine whether or not a patient expresses an adequate PD-L1 signal to pursue therapy. These categories are:

  • TPS ≥ 50% (High PD-L1 expression)
  • TPC 1-49% (PD-L1 expression)
  • TPS < 1% (No PD-L1 expression)

Indications:

  • Pembrolizumab (KEYTRUDA®) is indicated for treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] greater than or equal to 50%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC.
  • Pembrolizumab (KEYTRUDA®) is indicated for treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS greater than or equal to 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Pembrolizumab (KEYTRUDA®).

Test limitations: A minimum of 100 neoplastic cells are recommended in order to maximize the clinical utility of this assay.

How does PD-L1 therapy work?

ORDER PD-L1 with OmniSeq Comprehensive