Government Support for Research & Development Programs

The evolution of multi-omic technologies has rapidly increased the understanding of molecular complexities of disease, driving the current trend towards the simultaneous investigation of multiple biomarkers from one panel. As a result, smarter biomarker solutions are required to meet the growing needs of our Biopharma and Academic clients.

Almac Diagnostic Service’s current Research and Development (R&D) Programs are focused on DNA & RNA Next Generation Sequencing (NGS) platforms to:

  • Optimize biomarker discovery & translational research.
  • Develop robust NGS solutions for the development & validation of Clinical Trial Assays.
  • Provide multiple readouts from a single solid tumor or liquid biopsy sample.

Almac Diagnostic Services has been awarded Government funding to support two R&D programs designed to enhance our service offering to support our clients’ drug development pipelines.

Program One:

“Development of a next generation genomics biomarker platform for immune oncology (IO) therapies” For more information visit Whole Exome Sequencing.

Overview:

This program consists of the establishment of a Next generation Sequencing (NGS) and Artificial Intelligence (AI) powered biomarker platform for identification and interpretation of DNA based aberrations.

Deliverables:

  1. Established robust wet and dry lab protocols for cost effective and comprehensive Whole Exome Sequencing (WES) data generation and QC, from challenging material such as Formalin Fixed Paraffin Embedded (FFPE) tissue, for biomarker discovery purposes.
  2. Proprietary Oncology and IO relevant biomarker assay pipelines, including specific variant calling, Tumor Mutation Burden (TMB) and Microsatellite Instability (MSI) biomarkers as well as Hallmarks of Cancer and resistance mechanisms, that are reported in a clear and interactive format.
  3. Validated Investigational Use Only (IUO) biomarker solution to identify multiple variants & assays from FFPE material for use in prospective clinical trials.

Government Support for Research & Development ProgramsThis R&D program is supported by an investment of £885k from Invest Northern Ireland via the Grant for R&D Program, over 3 years, from 2018 – 2021. This project is part-financed by the European Regional Development Fund under the Investment for Growth and Jobs Program 2014-2020.

 

Program Two:

“Almac’s novel biomarker platform for patient stratification within immune oncology clinical trials.” For more information visit claraT.

Overview:

This program harnesses our 15 years’ experience in the discovery, development and commercialization of gene expression (GE) based diagnostic tests. The goal is to develop and validate a comprehensive NGS platform and proprietary report that classifies gene expression signatures according to the Hallmarks of Cancer.

Almac’s proprietary claraT Total mRNA Report is a unique software-driven solution, classifying biologically relevant gene expression signatures into a comprehensive, easy-to-interpret report. A pan-cancer solution, based on a powerful bioinformatics pipeline, automatically generating the claraT report from raw gene expression data utilizing the Almac optimized RNA Exome Panel.

Deliverables:

  1. Established wet and dry lab protocols for cost effective and comprehensive RNA Exome Sequencing, from challenging material such as FFPE tissue, for biomarker discovery purposes.
  2. Bioinformatics pipelines to classify gene expression signatures representative of the 10 Hallmarks of Cancer (including Almac’s proprietary DDIR, EMT and Angiogenesis signatures alongside publically available validated signatures).
  3. Software pipelines to report the signature outputs and single gene targets classified by the Hallmarks of Cancer in an interactive, visual manner (claraT).
  4. A robust platform analytically validated to IUO standard for selected key clinically actionable gene expression signatures in the Immuno-Oncology treatment setting.

Government Support for Research & Development ProgramsThis R&D program is supported by an investment of £500K from Innovate UK, via the December 2017 Sector Competition, over three years, from 2018 – 2021.