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).
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.
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
For pricing and ordering information, please contact firstname.lastname@example.org or 888-927-4366.