CLIA compliant assay, for clinical trial use, including US and Europe
Validation performance specifications for review on Almac Diagnostics’ website
Almac Diagnostics, a global stratified medicine company specialising in biomarker driven clinical trials, has analytically validated Illumina’s TruSight® Tumor 170 cancer mutation panel as an IUO assay for prospective testing in clinical trials
Almac Diagnostics is now in a position to partner with interested Pharmaceutical and Biotech firms with the Almac clinical trial assay to support clinical trial enrichment for future cancer trials.
Almac Diagnostics was one of only a handful of labs globally to be granted beta test site status for the Illumina TruSight® Tumor 170 panel. This facilitated early access to the RUO version of the panel prior to Illumina’s initial commercial release back in 2016 and has allowed the labs at Almac to build up a vast amount of experience with the cancer panel over an extended period of time.
The Almac Illumina TruSight® Tumor 170 Clinical Trial Assay is a Next Generation Sequencing (NGS) assay for use with FFPE tissue from solid tumours that targets DNA and RNA variants from the same sample. The Almac assay covers common cancer genes including key actionable mutations across multiple cancers. It targets single nucleotide variants, indels and gene fusions. The clinical trial assay does not cover amplifications or splice variants, but these can be identified in the RUO version of the assay also offered by Almac Diagnostics.
Michael Sloan, Global VP of Commercial Development, Almac Diagnostics said: “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.
He continued: “It’s a strong tool in our repertoire of broad screening assays for our clients. This offering can enable them to assess both DNA and RNA on an appropriate broad range of genes. From the Pharma or Biotech perspective, they’re going to have a drug, or a panel of drugs, for which they want to select a relevant biomarker to enable personalised treatment. So it’s an optimal screening mechanism for them.”
Almac Diagnostics offers clients powerful reporting for the assay through their own bioinformatics pipeline and software solution providing enhanced variant call reproducibility, accuracy and QC. Should clients also need further RUO interpretation of detected variants, Almac can also offer ‘IBM Watson for Genomics’ reporting for processed samples.