Almac Diagnostic Services has significant experience in custom Clinical Biomarker & CDx development, validation & delivery.
We can also provide support for other Diagnostic Development Partners (such as platform and reagent manufacturers) including acting as a reference site for analytical validation studies, support for orthogonal testing, regulatory consultancy (including IVDR) & acting as a clinical testing site for clinical trials.
Almac can develop, manufacture and commercialise CDx either as Lab Developed Tests (LDT) or Kitted Solutions.
We offer a range of platform and chemistry options including NGS, qPCR, nanoString and a range of IHC platforms alongside an expert software development team.
Almac also offer a full clinical testing service from our global clinical laboratories in USA, Europe and APAC.
We offer:
Pharmacodynamic (PD) Biomarker Development
Custom Assay Development & Validation (RUO, IUO)
Support for Diagnostic Development Partners
Assay Design & Migration
Platform Selection & Migration
Control Gene Selection
Analytical Validation
CDx Development, Manufacture & Commercialisation
Phase I, II and III Clinical Trial Testing