CDx Feasibility and Prototype Biomarker Assay Development

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 that streamlines the assay development process and provides a detailed technical report (assay reproducibility, assay optimization conditions, data analysis) that can enable further IVD development. As part of the CDx Feasibility and Prototype Biomarker Assay Development Program, ACD will provide:

  • Complete probe verification in cell pellets and/or tissue samples
  • Assay prototype study on m automated platforms
  • Reproducibility tests including inter-run and intra-run assays.
  • Data analysis: Our scientists will work with your team to determine the criteria to qualify samples and to classify tissue specimens according to the needs of the study.

Assay transfer: ACD will produce a detailed technical report describing the RNAscope assay conditions optimized for the tissues of interest. Our Field Application Specialist will work closely with your team to ensure successful training of the protocol and enable a faster transfer into your lab or external lab of your choice.

Assay Services by CLIA-Certified Providers

For Phase II clinical trials and beyond, our CLIA-Certified RNAscope® Service Provider program is designed to support clinical trials for Advanced Cell Diagnostics’ leading pharmaceutical clients.

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