Discovery Life Sciences (Discovery) has recently incorporated additional capabilities to the services offered within its three Tissue Biomarker Services (TBS) laboratories located in Newtown PA, Huntsville AL, and Kassel, Germany.

Each of these laboratories is capable of supporting IHC services in relation to pre-clinical, assay development, validation, retrospective and prospective clinical testing. Here, we present our capabilities and experience in providing IHC testing services in support of clinical programs for experimental Antibody-Drug Conjugate (ADC)therapeutics.

Based on our experience, we can develop and provide immunohistochemistry (IHC) biomarker tests to support their use in understanding expression rates across normal and diseased tissue, therapeutic mechanism of action, pharmacodynamic effects as ascertained by supporting markers, and expression levels of the marker targeted by an experimental therapeutic. In another service area, we introduce our capability of supporting multiplex immunofluorescence (mIF) development, validation, preclinical, and clinical studies. We also present our workflow that supports clinical studies with testing in both US and EU sites whereby Discovery is compliant with IVDR requirements. Lastly, the Discovery Biomarker Academy provides pathology expertise for cross-laboratory concordance studies and post-approval CDx pathologist training.

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