We are pleased to announce that we have analytically validated the Illumina TruSight® Tumor 170 cancer mutation panel. The assay is CLIA compliant for prospective clinical trial use, including Europe and the US.

Almac Clinical Trial Assay

Almac Diagnostics has invested in the validation of this CLIA compliant assay and the full validation report is available on request.

Read the Validation Performance Specification

This Almac Diagnostics clinical trial assay will provide Pharmaceutical and Biotech companies with a new option in the marketplace to support their clinical trials and CDx development. The assay, based on the Illumina TruSight® Tumor 170 chemistry and NextSeq platform, allows multiple biomarkers to be evaluated from one sample, thereby reducing the quantity of precious tissue sample necessary and offering a highly cost effective solution that will ultimately be kit-able further downstream.

Almac Diagnostics offer clients powerful reporting for the assay through our own bioinformatics pipeline and software solution providing enhanced variant call reproducibility, accuracy and QC.

Contact us today to discuss your requirements for future clinical trial enrichment.

Almac RUO Assay

Almac Diagnostics also offer Illumina TruSight® Tumor 170 panel as a research use only (RUO) assay. Should clients need further RUO interpretation of detected variants, Almac can offer ‘IBM – Watson for Genomics’ reporting for processed samples.

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Almac CLIA validated assay

The Assay

The Almac Illumina TruSight® Tumor 170 Clinical Trial Assay is a Next Generation Sequencing (NGS) assay that targets DNA and RNA variants from the same sample. The assay covers 170 common cancer genes including key actionable mutations across multiple cancers.

Further information, including the full list of cancer genes, can be found on the following assay summary sheet.

Almac IUO Assay Summary Sheet View Illumina RUO Assay Summary Sheet

At a Glance

Illumina enrichment based targeted NGS panel run on the NextSeq500 and NextSeq550

Covers 170 genes associated with common solid tumors

Compatible with FFPE tissue and simultaneously analyses both RNA and DNA from a single sample

Targets all coding exons in 170 genes including 55 genes for fusions and splice variants, 148 for SNVs and Indels, and 59 genes for CNV * (CNV and Splice Variants – RUO Assay Only)

Capable of detecting somatic mutations as low as 5% mutant allele frequency, with >96% positive percentage agreement

Key Benefits

  • Evaluate multiple biomarkers on one panel from one sample
  • Works from minimal tissue inputs
  • Rapid turnaround time
  • Access to raw data
  • Powerful reporting and interpretation of data
  • Bespoke Almac bioinformatics pipeline providing enhanced variant call reproducibility, accuracy and QC
  • Highly competitive price
  • A solution that will be kit-able in future to support multiple CDx tests

Key Facts

Metric Almac Dx TruSight® Tumor 170
Sample Input Requirement – DNA & RNA 40-120ng DNA
40-85ng RNA*
Sample Input Requirement – Tissue ≥1mm³ ∞
Turnaround Time 9 days §
Customisable Content Yes
Raw Data Provided with Report Yes

*Ability of TST-170 to analyse RNA alows for detection of expressed fusion genes resulting from both chromosomal abnormalities and posttranscriptional events and thus detects gene fusions that DNA sequencing panels would not recognize. ∞ Variable across tissue type; Melanoma would require more tissue; Tissue fixation has greatest influence upon sample QC and assay performance. § From sample receipt, inclusive of pathology review

Almac Diagnostics Testing

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Almac Diagnostics - Illumina TruSight® Tumor 170 – Validated Assay: Enabling Biomarker Led Clinical Trials and CDx Development.

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In the Press

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Almac Diagnostics Validates Illumina TruSight® Tumor 170 Cancer Mutation Panel for Prospective Testing in Clinical Trials

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Almac Diagnostics and EORTC Establish Collaboration for Tumour Molecular Profiling using Illumina TruSight® Tumor 170 panel

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Illumina interview Almac Diagnostics on leveraging TruSight® Tumor 170 and being a key beta test site for the panel

Almac Trusight diagnostics in the lab
Almac Diagnostics were selected as one of Illumina’s key Beta Test sites for TruSight Tumor® 170. This facilitated early access prior to commercial release. We have built up a vast amount of experience with the assay that Pharma and Biotech partners can benefit from.