Anatomic Pathology plays an important role in biomarker selection and companion diagnostics. This episode describes three key challenges in immuno-oncology development related to anatomic pathology. Some of the key issues organizations that support clinical trials I-O drug development face, particularly with companion diagnostics, involve ensuring the sample availability is adequate and appropriate for the different clinical trials, that the assay outcome is useful, and the results are relevant for the clinical trials. Many assays for the determination of PD-L1 status in most tumor types are based on immunohistochemistry, or IHC. Also, companion diagnostic strategies that are using multiple PD-L1 clones for related drugs in development are rapidly evolving.

Having adequate tissue samples is one of the most critical components; or “tissue is the issue.” It's also important that the sites that are sending samples have the ability to process samples in a timely manner, establishing that the fixation and other pre-analytical conditions that influence the outcome of the results are well evaluated. The podcast reviews our solutions that strive to make the whole process easier for patients and doctors alike.