USFDA: Green signal to PD-L1 IHC 22C3 pharmDx - P150013/S014

The USFDA grants green signal to PD-L1 IHC 22C3 pharmDX. The lab test used by doctors for checking head and neck squamous cell cancer having programmed cell death ligand 1 (PD-L1) in their cancer is done by PD-L1 IHC 22C3 pharmDx.

The small piece of cancerous tissue from the patient is sent to a lab. The lab, then puts the cancerous tissue into wax and cuts a thin slice of it. It is then treated with the test slice. If the slice has PD-L1, it will stain dark brown when the pathologist observes the slice. The lab tells the doctor if PD-L1 was present in the slice and whether or not the sample is positive based on criteria that are specific for each cancer type.

PD-L1 IHC 22C3 pharmDx can be used by doctors to help in confirming whether a patient is eligible for treatment with KEYTRUDA®.

There are no known contraindications associated with this test.