Companion Diagnostics Assay Development Program

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.

RNAscope holds great promise for increasing the clinical success of certain drugs by serving as a companion diagnostic (CDx). ACD has therefore created a CDx Assay Development Program that streamlines the assay development process, and provides a detailed Standard Operating Protocol (SOP) that can be transferred to a certified CLIA labs.

As part of the CDx Assay Development Program, ACD will provide:

  • Complete probe verification in cell pellets and/or tissue samples
  • Assay development study on manual or 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 patients according to the needs of the study.
  • Assay transfer: ACD will produce a detailed standard operating procedure (SOP) 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 and quick transfer into your laboratory or a CLIA lab of 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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Advanced Cell Diagnostics

Our new headquarters office starting May 2016:

7707 Gateway Blvd.  
Newark, CA 94560
Toll Free: 1 (877) 576-3636
Phone: (510) 576-8800
Fax: (510) 576-8798


Advanced Cell Diagnostics , S.r.l.
Via Calabria15
20090 Segrate (Milano) - Italy

Phone: +39.02.95360323
Fax: +39.02.95360992
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Building 15, No. 26 Xihuan South Road
Beijing Economic-Technological Development Area
Beijing, China, Zip code: 100176

For general information: Leon Li

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