Clinical Trials Endpoints

We are focused on delivering histologic or "tissue-based" clinical trials endpoints. These are especially important in various disease states wherein blood-borne markers or clinical parameters may provide an incomplete picture of the disease process. Examples include fatty liver disease, inflammatory bowel disease, fibrotic diseases, cancers, and many, many others.

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In our experience, there are a few common categories of histologic endpoints. First, simple histomorphological scoring systems based on routine tissue sectioning and staining can be extremely powerful (see references). These are enhanced via digitalization and quantification. Second, single analyte macromolecules such as a specific protein or nucleic acid. Third, a multiplex panel of molecules that relate in some way to the disease or treatment mechanism. Fourth, unbiased 'comprehensive' panels or -omics platforms. Fifth, spatial or volumetric evaluations of any of the above. These categories can each theoretically be developed and utilized for companion diagnostics, clinical trials endpoints, and/or the clinic.