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CDx Feasibility and Prototype Biomarker Assay Development Service
There is growing interest in RNA-based biomarkers and measuring RNA expression holds great promise for stratifying patients based on drug response, drug efficacy and risk of side effects. RNAscope in situ hybridization enables molecular detection in a morphological context. It provides the cellular resolution required to evaluate tissue heterogeneity and to potentially better screen and select patients.
The use of RNAscope ISH as a companion diagnostic (CDx) has been critical to the increasing clinical success of certain drugs. With this in mind, ACD developed a CDx Feasibility and Prototype Biomarker Assay Development program. The Professional Assay Services team of scientists, pathologists, and technical experts has a decade of experience in developing assays for clinical applications and enabling companion diagnostic development. The established workflow includes assay development and optimization followed by demonstration of specificity and sensitivity, stability, robustness, repeatability and intermediate precision, and other validation parameters.