ena-STUDY-Agendia NV-21-03-2019-10:56:00:451-23
In this study we show that targeted RNA-seq can be used in routine clinical diagnostics and it delivers reproducible and clinically valid results
Next Generation DNA sequencing (NGS) is rapidly becoming an indispensable tool for genome-directed cancer diagnostics, but Next Generation RNA sequencing (RNA-seq) is currently not standardly used in clinical diagnostics for expression assessment. However, multi-gene RNA diagnostic assays are used increasingly in the routine diagnosis of early stage breast cancer. We show here that newly developed 70-gene and 80-gene RNA-seq tests deliver equivalent technical and clinical results to the reference standard microarray tests, they are highly reproducible when performed in different locations and they are stable over-time. Our data demonstrate that RNA-seq can be used as diagnostics platform, yielding results substantially equivalent to results derived from the predicate diagnostic device.
Next Generation DNA sequencing (NGS) is rapidly becoming an indispensable tool for genome-directed cancer diagnostics, but Next Generation RNA sequencing (RNA-seq) is currently not standardly used in clinical diagnostics for expression assessment. However, multi-gene RNA diagnostic assays are used increasingly in the routine diagnosis of early stage breast cancer. We show here that newly developed 70-gene and 80-gene RNA-seq tests deliver equivalent technical and clinical results to the reference standard microarray tests, they are highly reproducible when performed in different locations and they are stable over-time. Our data demonstrate that RNA-seq can be used as diagnostics platform, yielding results substantially equivalent to results derived from the predicate diagnostic device.