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

ICON Specialty Laboratories (formerly MolecularMD) 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. 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. Specimen expertise includes formalin-fixed paraffin-embedded tissue (FFPE), bone marrow, fine needle aspirates, core biopsies and peripheral blood.

Our platform-agnostic approach to test development spans the following technology platforms:

  • Next Generation Sequencing
  • Droplet digital PCR (ddPCR)
  • qPCR
  • RT-qPCR
  • Allele-Specific PCR
  • Sanger Sequencing
  • Capillary Electrophoresis Fragment Analysis
  • Immunohistochemistry (IHC)
  • Hematoxylin and Eosin Staining (H&E)
  • Digital Imaging