ACD's Pharma Assay Services group has been developing RNAscope™ and BaseScope™ biomarker assays for our biopharma partners for nearly a decade. Our biomarker assays have contributed 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 and BaseScope 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.
As with all Pharma 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.
Pharma Assay Services protocol development and validation criteria include:
- Reproducibility
- Precision
- Specificity
- Sensitivity
- Stability
- Robustness
- Dynamic range
View an example of an abridged biomarker assay dataset
generated for Wilms tumor 1 (WT1), a cancer vaccine target
