Application of RNAscope™ ISH 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 tumor biopsies.
Clinical trial cell therapy multiplexed analysis:
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.
Preclinical cell therapy development
Cell therapy detection and activation assays in animal models
Viral vector copy number (VCN) assays
DNA in situ hybridization measurements of viral copy number in cell therapy product
Safety assessment
Viral vector DNA and RNA ISH assays to rule out role in patient secondary tumors
Wright et al., (2021), Detection of engineered T cells in FFPE tissue by multiplex in situ hybridization and immunohistochemistry. J of Immun Methods. 492: 112955. (hyperlink the journal article to: https://www.sciencedirect.com/science/article/abs/pii/S0022175920302490)
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
RNAscope assays of CAR-T and TCR-T cells. (Left) RNAscope probes against CAR 3’UTR (red) and GZMB (green) reveal infiltration and activation of ROR1-targeted CAR-T cells in ROR-positive mouse lung and liver. Concurrent RNAscope assessment of ROR1 (red) confirms antigen signal in mouse lung and liver. (Middle) BCMA-targeted CAR-T cell infiltration and activation in BCMA-positive xenograft tumor demonstrated using RNAscope CAR 3’UTR (green) and IFNG (red) probes multiplexed with CD3 immunofluorescence (white). (Right) Infiltrating NY-ESO-1 TCR-T cells and local recruitment of CD3-positive T cells in post-treatment liposarcoma patient biopsy were observed using the RNAscope Duplex assay with TCR UTR (red) and CD3E (green) 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.