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Biomarker Assay Development

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(TM) and miRNAscope(TM) 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 sensitvity 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.

View an example of an abridged biomarker assay dataset
generated for Wilms tumor 1 (WT1), a cancer vaccine target

Recorded Webinar

ACD RNAscope for Biomarkers CDx Webinar Dr Christopher Bunker

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Advanced Cell Diagnostics

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