PD-L1 IHC 22C3 pharmDx

PhenoPath is proud to announce the release of FDA-approved PD-L1 IHC 22C3 pharmDx, for the semi-quantitative assessment of PD-L1 expression in non-small cell lung carcinomas (NSCLC).

PD-L1 IHC 22C3 pharmDx is the first and only FDA-approved companion diagnostic to assess NSCLC patients for KEYTRUDA® (pembrolizumab).

Clinical Indication(s):

Per the Dako SK006 Data Sheet, “KEYTRUDA® (pembrolizumab) is a humanized monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.  PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for eligibility for treatment with KEYTRUDA® (pembrolizumab)”.

PD-L1 protein expression is determined by using Tumor Proportion Score (TPS), which is the percentage of viable tumor cells showing partial or complete membrane staining. A TPS ≥ 50% is positive for PD-L1.

Which PD-L1 test should I order? Click here for more information.

For more information about the FDA news release, “FDA approves KEYTRUDA® (pembrolizumab) for advanced non-small cell lung cancer,” please refer to: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm465444.htm

For more information about KEYTRUDA® (pembrolizumab), please refer to: https://www.keytruda.com

CPT code: 88360

Alternate Test Names: 22C3, PDL1

Turnaround time: 1-2 business days of receipt

Specimen Requirements:

• Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR -
• 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm

For pricing and ordering information, please contact lab@phenopath.com or 888-927-4366.