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Clinical Biomarker & CDx Development

Clinical Biomarker & CDx Development Tablet Image Clinical Biomarker & CDx Development Mobile Image
Mobile Gradient

Clinical Biomarker & CDx Development

 
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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

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