Assay Development, Biomarkers


Almac offers biomarker delivery from our CLIA registered CAP accredited clinical laboratory.  We can offer this service as part of our overall biomarker clinical trial management service or as a standalone service.

Clinical testing is available both for prospective testing (e.g. for trial recruitment) and for retrospective assay application, as early as Phase I and Phase II for trial enrichment.

We offer centralised clinical testing for trial enrichment in early stage trials under CLIA for US based trials and GCP for the rest of the world, as well as testing on multiple platforms with the rapid turnaround time as required to support the decision making process in trial recruitment.  The key components of the service include;

  • Distribution of sample collection kits to clinical sites
  • Production and control of trial-specific documentation (including Test Requisition, operations manual etc)
  • 24/7 sample receipt
  • Pathology review (if required)
  • Independent diagnostic confirmation (if required)
  • Multiple testing platforms
    • IHC
    • qPCR
    • Array
  • Patient test reporting to clinical sites
  • Regular clinical trial data delivery to sponsors


‘Developing and Applying Biomarkers in Early Phase Clinical Trials’

For further information click here to contact us.

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