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 |
RT-qPCR
|
|
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 |