A decade of experience as a service provider, delivering 15,000+ stained slides per year
ACD's Professional Assay Services group has been developing RNAscope™ biomarker assays for our biopharma partners for a decade. Our biomarker assays have contributed to important clinical trial exploratory endpoints, enabled more accurate patient selection, and are leading to CDx development with our partner, Leica Biosystems. Leveraging the unrivalled sensitivity and specificity of ACD’s ISH technologies, RNAscope or BaseScope biomarker assays can be developed for any therapeutic target, including those that are challenging for antibody detection such as many 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 often correlate better with response to treatment whereas less sensitive IHC assays 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.
As with all Professional Assay Services studies, biomarker assay development projects are customized according to the needs of the sponsor, the specific biomarkers and the intended use. The team is experienced in developing assays and conducting bioanalytical validation studies under tight timelines, as well as in conducting retrospective exploratory biomarker studies on clinical trial biopsies. In addition, we have transferred many RNAscope biomarker assays to our CLIA lab partners for use in patient selection.
Professional Assay Services (PAS) provides GCLP-compliant RNAscope, BaseScope™, and miRNAscope™ in situ hybridization (ISH) assay services to support clinical and pre-clinical studies for our academic and biopharma partners. We provide end-to-end solutions from sample procurement to ISH staining to image analysis and reporting. Researchers who partner with Professional Assay Services will receive access to the most specialized and technically experienced RNAscope services of any CRO, provided by an expert multi-disciplinary team that includes PhD scientists and MDs, who serve our clients as technical experts, image analysis specialists and board-certified pathologists, spanning a broad array of scientific disciplines. With direct access to the developers of the technology, the PAS team provides unparalleled expertise in Bio-Techne’s ISH platforms and delivers fast, high quality data designed to meet your study objectives and timelines.
A decade of experience as a service provider, delivering 15,000+ stained slides per year
An established history of servicing 28 of the 30 global pharmaceutical companies as well as dozens of cell and gene therapy biotech companies
Ph.D. level scientists and MD pathologists who are specialized experts and provide scientific consultation for study design and data interpretation
Target validation. Screen and validate candidate targets by assessing target expression levels 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
