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Trusight Oncology 500 High Throughput (TSO500HT)

Every patient is unique, and so is their cancer. The constellation of mutations present in cancer cells plays a role in the patient’s response to therapy. Therefore, it is crucial to understand the pattern of mutations in order to select the most appropriate treatment for each person’s cancer. The TruSight Oncology 500 test is a next-generation sequencing assay designed to cover over 500 genes associated with common solid tumors, including assessment of fusions, splice variants, insertions/deletions and single-nucleotide variants (SNVs), and amplifications. This comprehensive test helps providers diagnose and treat each unique cancer to improve patient outcomes.

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Reporting

  • The TruSight Oncology 500 test includes standardized analytics and reporting of multiple variant types in a single assay, including small nucleotide variants (SNVs), insertions/deletions (indels), copy number variants (CNVs), splice variants, fusions, and emerging immunotherapy biomarkers that rely on analysis of multiple genomic loci, such as tumor mutational burden (TMB) and microsatellite instability (MSI). Pathology services and additional interpretation and consultation by a board-certified Molecular Pathologist is also available for this test.
  • Sample Report

Turnaround Time (TAT)

  • Turnaround time from sample receipt to final report is 14 days.

Specimen Requirements

  • FFPE blocks (preferred): select a block that is representative of the tumor and has a minimum of ~20% tumor cellularity (by nuclei).
  • Slides: 1 H&E stained slide and 10 consecutive, unstained slides of 5 μm thick sections. If H&E stained slide is not available, submit an 11th slide for staining. If slides are labeled with only one identifier, they must be securely submitted in a container labeled with two identifiers.
  • Extracted DNA/RNA: submit a minimum of 300 ng at ≥10 ng/μL of purified DNA, and a minimum of 500 ng at ≥10 ng/μl total RNA (≥20 ng/μl preferred). Specimens must be submitted in a screw cap tube. AllPrep DNA/RNA FFPE kit for extraction and resuspension in DNA-ATE buffer (for DNA) or RNase-free water (for RNA) is preferred.

Test Specifications

This test(s) was developed, and performance characteristics were determined by the HudsonAlpha Clinical Services Lab, LLC. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. These tests are used for clinical purposes, and therefore validation was done as required under the requirements of the Clinical Laboratory Improvement Act (CLIA) of 1988. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. The chance of a false negative or a false-positive result due to laboratory error cannot be completely excluded. These results should not be regarded as investigational or for research.