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PD-L1 IHC 73-10 pharmDx

The Dako 73-10 assay, the fifth PD-L1 US FDA-approved diagnostic test, was co-developed and commercialized to support the use of avelumab therapy. Clone PD-L1 73-10 is a monoclonal rabbit antibody property of Merck (KGaA, Darmstadt, Germany) optimized to detect PD-L1 expression in FFPE samples. Although a cutoff has not been definitely determined, the pre-defined PD-L1 positivity is considered when a complete circumferential or partial linear plasma membrane staining is observed at any intensity in at least 1% of tumor cells. Since this assay is still in development, the minimum of viable tumor cells required to determine the TPS is still undefined.