TruSight Oncology Comprehensive
The first CE-marked IVD kitted solution for comprehensive genomic profiling (CGP) of DNA and RNA variants, plus MSI and TMB, for multiple solid tumor types.
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TruSight Oncology Comprehensive (EU) is a CE-marked IVD next-generation sequencing (NGS)-based CGP for analyzing > 28 solid tumor types using minimal tissue.
- Detect DNA plus RNA variants along with biomarker signatures such as TMB and MSI
- Save time and money by assessing multiple biomarkers in a single test
- Enable targeted therapies and clinical trials with actionable, easy-to-interpret results
TruSight Oncology Comprehensive (EU) is an in vitro diagnostic test that uses targeted next generation sequencing to detect variants in 517 genes using nucleic acids extracted from formalin-fixed, paraffin embedded (FFPE) tumor tissue samples from cancer patients with solid malignant neoplasms using the Illumina NextSeq 550Dx instrument. The test can be used to detect single nucleotide variants, multinucleotide variants, insertions, deletions and gene amplifications from DNA, and gene fusions and splice variants from RNA. The test also reports a Tumor Mutational Burden (TMB) score and Microsatellite Instability (MSI) status.
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MiSeqDx System
IlluminaThe MiSeqDx instrument is the first and only FDA-cleared in vitro diagnostic (IVD) next-generation sequencing (NGS) system. Designed specifically for the clinical laboratory environment, the MiSeqDx instrument offers a small, approximately 4 square feet (0.37 square meters) footprint, an easy-to-follow workflow, and data output tailored to the needs of clinical labs. In addition, the integrated software enables sample tracking, user traceability, and results interpretation.Taking advantage of proven Illumina sequencing by synthesis (SBS) chemistry, the MiSeqDx instrument provides accurate, reliable screening, and diagnostic testing.MiSeqDx System Features & Benefits: First and Only FDA-cleared IVD NGS System - As an FDA-cleared IVD system, the MiSeqDx instrument meets guaranteed performance characteristics so you can feel confident that you are generating accurate and reliable data. Simple NGS Workflow - The compact, all-in-one instrument incorporates cluster generation, paired-end fluidics, sequencing by synthesis chemistry, and complete data analysis. Enhanced User Security - Equipped with Illumina User Management Software that enables laboratories to control and trace system access, ensuring that only authorized personnel are running tests. Proven, Well-Published Technology - The most widely adopted NGS technology worldwide, with references in more than 3,300 peer-reviewed publications. The MiSeqDx system uses the same proven reversible-terminator SBS chemistry used by all Illumina sequencing platforms. User-Friendly, Intuitive Software - The first IVD NGS to offer a fully integrated sequencing ecosystem. Instrument software is accessed through a user-friendly touch screen interface. For In Vitro Diagnostic Use. Contact an Illumina representative for regional availability.
NextSeq™ 550Dx Next-Generation Sequencing System
IlluminaThe next level in diagnostic power for the clinical lab
