Professional Assay Services
In Vitro Technologies is proud partner with ACDBio for PROFESSIONAL ASSAY SERVICES
In situ hybridization (ISH) assay services to support pre-clinical and clinical studies for pharma and biotech partners globally.
It offers:
- Tissue sectioning
- ISH staining
- high resolution full slide scanning
- Scoring
- image analysis
These are performed by a dedicated team of highly trained specialists, scientists, and board-certified pathologists.
With direct access to the developers of the technology, the Assay Services team provides unparalleled expertise in our ISH platform and delivers fast, high quality data designed to meet your study objectives and timelines.
Why Choose PAS as Your ISH Service Provider?
With 10 years of experience as a contract research organization (CRO) specializing in RNAscope™ ISH.
We have supported thousands of clinical and pre-clinical projects with every major biopharma in the United States and globally.
Each project is individually tailored and managed by our team of scientists, specialists, board certified pathologists, and data experts
- 15,000+ slides delivered per year
- 500+ target-specific tissue expression studies validated and successfully performed
- 150+ tissue types including normal human, clinical disease specimens, preclinical models, humanized mouse and syngeneic mouse tumor models
- GCLP (Good Clinical Lab Practices) compliant lab procedures based on WHO (World Health Organization) guidelines
- 15+ automated staining systems from Leica Biosystems and Ventana Medical Systems
What We Offer:
- Tissue-Based Expression Analysis
- Target validation. Screen and validate candidate in drug-treated versus naïve samples or disease vs normal tissues
- Biomarker assay development. Evaluate candidate biomarker expression and establish assay performance and dynamic range using bioanalytical method validation guidelines
- AAV biodistribution. Profile the spatial distribution of AAV vector together with genetically modified transgenes to assess biodistribution and safety
- CAR/TCR biodistribution and function. Visualize the biodistribution of CAR T or TCR T cells within the tumor microenvironment and assess functionality with co-detection of immune cell markers and/or markers of activation
- Safety/toxicology tissue screening. Single-molecule detection for high sensitivity screening of normal tissues for pre-clinical ADME and safety assessment
- CDx assay development. Partner with ACD to support the assay prototype development, proof of concept and validation steps of your RNAscope CDx assay
Leveraging the unrivalled sensitivity and specificity of ACD’s ISH technologies,
The benefits:
- Addressing challenging antibody detection such as neo-antigens, cancer vaccine and TCR targets, as well as highly homologous gene families such as MAGEA.
- RNAscope, BaseScope™ and miRNAscope™ biomarker assays are typically more sensitive than IHC and correlate better with response to treatment
- Moving away from less sensitive IHC assays which can report false-negative results.
- The digital “dots per cell” read-out of RNAscope enables objective quantification of biomarker expression for establishing more accurate thresholds for patient selection.
- We can qualify biomarkers with disease progression and/or clinical endpoints with high precision in order to stratify patient populations to guide personalized treatment.
- Custom probes with high specificity and sensitivity against novel targets can be designed in 1-2 weeks, dramatically shortening the time for assay development to weeks rather than months.
View an example of an abridged biomarker assay dataset
generated for Wilms tumor 1 (WT1), a cancer vaccine target
> Download the WT1 Detection Dataset Flyer
Any gene, any species, any tissue.
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:
> It provides the cellular resolution required to evaluate tissue heterogeneity.
> Assist with better screening and patients selection.
ACD's biomarker assays have contributed to important clinical trial exploratory endpoints, enabled more accurate patient selection, and spearheaded CDx development with our partner, Leica Biosystems.
Recorded Webinar
ACD RNAscope for Biomarkers CDx Webinar Dr Christopher Bunker
> Watch Webinar
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.
Our scientists produce a detailed technical report describing the 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.
To view certified laboratories, please follow this link: https://acdbio.com/biopharma-partners
Become a Certified Provider
Are you interested to provide RNAscope services locally?
ACD offers a certification procedure to qualified labs to enable them to provide RNAscope™ services.
Each service provider undergoes:
> comprehensive training on RNAscope technology, which includes all aspects from sample preparation, quality control, assay procedure, data interpretation and analysis.
> Following the training, the lab is required to independently run the assay and send data for review at ACD.
Contact us to find out more.
Cell therapy services is offered in our Good Clinical Laboratory Practices (GCLP) compliant Professional Assay Services laboratory.
RNAscope is the only assay that can specifically detection engineered cell therapies and measure target engagement in intact human tumour biopsies.
> Cell therapy detection with probes targeting viral or synthetic UTRs), e.g., WPRE
> Target engagement assays with probes to cytokines, e.g., IFNG,
> T cell recruitment assays by IHC/IF for detection of CD3, CD4, or CD8-positive T cells.
> Cell therapy detection and activation assays in animal models
> DNA in situ hybridization measurements of viral copy number in cell therapy product
> Viral vector DNA and RNA ISH assays to rule out role in patient secondary tumors
Morphological detection using RNAscope Assay
CAR-T and TCR-T cell therapy probes consisting of pooled (“ZZ”) oligos targeting viral untranslated regions (UTRs) of CAR and TCR mRNA
Recorded Webinar
RNAscope in situ Assays of Cell Therapy in Solid Tumors, Tumor Infiltration and Activation
> Watch Webinar
Adeno-associated virus (AAV) has proven to be an effective gene therapy delivery vehicle. The primary considerations in gene therapy preclinical in vivo animal studies are:
• vector biodistribution,
• cell-specific uptake
• transgene expression
• safety against germ line transmission.
While assays of extracted RNA and DNA from bulk tissue are simple, these provide only an average value for an entire complex tissue and lack cellular resolution.
RNA and DNA in situ hybridization using RNAscope™ and BaseScope™ assays combine the quantitative, molecular measurement, like PCR, with single-cell resolution in the context of intact tissue morphology.
Moreover, RNAscope enables simultaneous detection of AAV vector DNA and transgene mRNA expression, and it can be multiplexed with cell markers. It is a simple and reliable method for analysis of AAV in routine FFPE tissues.
Capabilities:
• AAV vector DNA detection and quantification in intact fixed tissue
• Probes designed to AAV promoter regions and anti-sense strand from AAV DNA detection
• Detection of therapeutic human- and codon-optimized transgene RNA without cross-hybridization to endogenous transcripts
• Morphology-based AAV vector biodistribution and transgene mRNA expression analysis in intact animal model tissues
• Visual and quantifiable assays to measure percentage of cells positive for vector and transgene expression
• Multiplexed analysis of cell-specific AAV and transgene mRNA with cell marker probes.
Recorded Webinar
Visual detection and quantification of AAV and LV vector biodistribution and transgene expression in preclinical animal models with RNAscope and BaseScope™ in situ hybridization.
> Watch Webinar
