Pharma Assay Service guarantees access to the expertise of technology developers and the latest product developments. With more than 5 years of experience, during which all types of tissue have been processed, thousands of probes have been designed and thousands of samples analyzed, we provide the expertise to ensure your success.
From sample selection to data analysis, our expert team can work on just a few or all the steps in your assay development process. Complete analysis is performed in 3 weeks on average after sample receipt.
- 01Tissue Processing
On receipt of the FFPE samples, a qualified histotechnician sections the samples as per ACD’s recommended guidelines to minimize turnaround time and to ensure freshness.
- 02RNAscope® Probe Design
ACD provides custom probe design services using the proprietary ACD RNAscope® probe design pipeline for any proprietary or novel gene target of interest. Custom target probes can be developed within 2 weeks. More importantly, ACD guarantees the probes, eliminating risk in your development timeline. Catalog probes are available off-the-shelf and can be used right away in Pharma Assay Services.
- 03Tissue Quality Control & Assay Optimization
Pretreatment conditions to permeabilize samples are highly dependent on the tissue type and quality. A tissue quality control step is performed using a positive control gene (PPIB) and negative control gene (bacterial dapB). This step is critical for determining the tissue and RNA quality of the sample to avoid false positives and false negatives, and also for establishing the optimal pretreatment conditions for your samples to maximize signal to noise. Optimization is performed by our team of experts, to ensure that you are receiving the best possible data from your samples, and the data is then transferred to your lab. These QC and optimization steps are performed in every Pharma Assay Service project and guarantee the best RNA ISH sensitivity and quantitative analysis range for your specific target(s).
- 04Target Analysis
The optimized pretreatment conditions established during the assay optimization steps are used to perform your target evaluation. Staining can be performed using the manual assay or using the Leica Bond, Ventana Discovery XT or Ultra platform for automated analysis. Once optimized conditions have been established, the addition of multiple targets is simply a matter of adding one further serial section. No further assay development is required.
- 05Semi-Quantitative and Quantitative Analysis
We offer 3 levels of analysis to address your specific needs: semi-quantitative, H-scoring and quantitative analysis using SpotStudio or HALO software. All analyses are performed by our team of qualified experts, including a research pathologist. Learn more about these different options.
- 06Summary Report
A complete summary report including optimized protocol and assay conditions, QC results, representative images of control and target staining, materials and methods, and scoring and analysis results (if selected) is provided for every project.
All stained slides and remaining unstained slides/tissue blocks are returned to the customer at the conclusion of the project.
ACD CDx Assay Development program streamlines the assay development process and provide a detailed SOP for easy transfer to a CLIA-Lab.Learn more
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.
Your benefits.Your success.
Outsourcing your project gives you the
flexibility to access innovative technology with
competent and trained personnel while minimizing
the cost and time investment.