Intended Use
The test is intended to provide information on somatic mutations, including single nucleotide variants (SNVs), small insertions and deletions (InDels), ERBB2 gene amplification, and fusions in ALK, RET and ROS1
Clinical Utility
Analytical validation supports reliable detection of clinically relevant genomic alterations. This validation demonstrates the device's performance in identifying these genomic alterations with high accuracy and precision. CNVs FUSION Dx Cell -Tissue provides comprehensive genomic profiling within the 517-gene panel of tumor samples
Single Site Testing
As a single-site test, quality control and interpretation are centrally managed, contributing to consistent analytical performance and faster result delivery.
