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PD-L1 IHC 28-8 pharmDx

PhenoPath is pleased to announce the availability of the PD-L1 IHC 28-8 pharmDx, the only FDA-approved test for PD-L1 expression associated with enhanced survival with OPDIVO® (nivolumab) for non-squamous NSCLC.

PD-L1 IHC 28-8 pharmDx is a complementary diagnostic to assess NSCLC patients for OPDIVO® (nivolumab).

Clinical Indication(s):

Per the Dako SK005 Data Sheet, “OPDIVO® (nivolumab) is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to 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 protein expression is defined as the percentage of tumor cells exhibiting positive membrane staining at any intensity, and will be scored according to the guidelines provided in the package insert and Interpretive Manual provided by Dako.

Note that this is a different test than the PD-L1 IHC 22C3 pharmDx, a different FDA-approved companion diagnostic for determination of eligibility of NSCLC patients for treatment with a different anti-PD1 drug, KEYTRUDA® (pembrolizumab).  PhenoPath is offering both of these tests for the oncology and pathology communities.

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

Related articles:

“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).” http://phenopath.com/news/pd-l1-ihc-22c3-pharmdx

“PhenoPath is pleased to offer the Roche cobas® EGFR Mutation Test (v2), an FDA-approved companion diagnostic for both first and second line therapy decisions for patients with non-small cell lung carcinoma (NSCLC)” http://phenopath.com/news/roche-cobas-egfr-mutation-test

For more information about the FDA news release, “FDA expands Opdivo in advanced lung cancer,” please refer to: http://goo.gl/qTmtvF

For more information about OPDIVO® (nivolumab), please refer to: http://goo.gl/2WDWLA

PD-L1 IHC 22C3 pharmDx

PD-L1 IHC 22C3 pharmDx

CPT code: 88360

Alternate Test Names: 28-8, 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.