ICON Specialty Laboratories streamline the co-development of flexible, platform-agnostic molecular diagnostic tests

ICON Specialty Laboratories offers specialty laboratory services to support a variety of therapeutic programmes. Our CAP-accredited, CLIA-certified laboratories offer fit-for-purpose, platform agnostic biomarker development services spanning a variety of molecular applications from NGS, PCR and IHC.

Our core business focuses on centralised clinical testing services and clinical trial assay and IVD development to support the ongoing needs of biopharma clients. Moreover, we work with clients to manage risks and optimise their return on investment by providing diagnostic services. Our capabilities include:

  • Clinical trial design
  • Assay development & validation
  • Sample banking and bridging studies
  • Global clinical trial management
  • Custom data reporting
  • Regulatory planning and FDA submission services

Sensitive and Highly Reliable Assays

We have developed sensitive and highly reliable protein and molecular assays, designed to detect targets within blood based and solid tumor malignancies. We have extensive experience in the context of clinical trials and cell and gene therapies including, but not limited to, the development of assays for pharmacokinetics (PK). A test menu of CLIA and RUO offerings exists with various diagnostic test types, to include SNPs, INDELs, copy number variations, translocations and/or transcript levels, vector copynumber (VCN) and replication competent lentiviruses (RCL). Specimen expertise includes formalin-fixed paraffin-embedded tissue (FFPE), bone marrow, fine needle aspirates, core biopsies, peripheral blood (whole blood, leukodepleted blood, blood cell pellet, PBMCs), enriched/sorted cells, and CSF.

Our platform-agnostic approach to test development spans the following applications and methods:

Application Methods
DNA Mutation Detection & Analysis

Next Generation Sequencing

Sanger Sequencing

Allele Specific-PCR

Digital PCR

Gene Expression Analysis
Protein Expression Analysis
Immunohistochemistry (IHC)
Digital Pathology Imaging and Quantitative
Structural Variation Detection and Analysis
(CNV, Fusions and Translocations)
Next Generation Sequencing
Liquid Biopsy/ctDNA
Next Generation Sequencing
Digital PCR
DNA/RNA Extraction Manual and Automated