Providing Targeted Cancer Diagnostics


PD-L1 22C3 EAMS Reference Laboratory

The Dako PD-L1 22C3 pharmDx test is FDA-approved for the identification PD-L1 expression levels in NSCLC and to assess their suitability for treatment with pembrolizumab (KEYTRUDA).

Following designation of Promising Innovative Medicine (PIM) status for pembrolizumab in November 2015 (EAMS Step 1), MHRA issued a positive Scientific Opinion on 15th March 2016 for pembrolizumab as follows:

Pembrolizumab as monotherapy is indicated for treatment in adults with metastatic non-small cell lung cancer (NSCLC) whose tumours express PD-L1 as determined by a validated test and:

  • who have not received prior systemic therapy and are negative for EGFR sensitising mutation and ALK translocation


  • whose disease has progressed on or after platinum-containing chemotherapy. Patients who have an EGFR sensitising mutation and ALK translocation should also have had disease progression on therapies for these aberrations prior to receiving pembrolizumab.

This testing is funded for all NHS patients.