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Specialty Laboratories

Supporting precision medicine programs across all phases of drug diagnostic co-development

ICON Specialty Laboratories partners with clients to design, verify and validate clinical trial assays (CTA) for patient selection, therapeutic efficacy, and monitoring.

 

We are at the forefront of precision medicine diagnostic technology and ensure reliable and accurate results for pivotal clinical end points.  Our CAP-accredited / CLIA-certified laboratories sites perform validation studies to support assays for PD studies, patient selection, or other primary, secondary and exploratory aims.

When you partner with ICON you have access to:

 

  • Extensive experience developing and validating soluble, cellular, and genetic/genomic biomarker assays to support clinical drug development programs, including Phase 1-3 global trials for various therapeutic areas with a special focus on oncology.
  • Biomarker assay technologies span across leading immunoassays, flow cytometry, IHC, NGS, ddPCR, and RT-qPCR/qPCR platforms.  
  • Dedicated scientific teams  who will provide expertise in custom assay design, plannign and risk mitigation, starting in pre-clinical/phase 1
  • Advanced technology platforms such as NGS, droplet digital PCR, and IHC to support emerging biomarkers
  • Replication competent lentiviruses (RCL)
  • Novel approaches that leverage advanced genomic platforms such as targeted RNA sequencing, tumour mutation load, liquid biopsy, and tumour infiltrating lymphocytes

 

We offer customised test report formats and distribution capabilities designed to meet the needs of clients, investigators and regulators. We support patient specimen collection with custom collection kits and shipping logistics.We track patient samples, providing chain of custody from accession, extraction, testing, data management and results reporting.

State certifications for the Portland lab include California, Florida, Maryland, New York, Pennsylvania and Rhode Island. The Cambridge lab maintains Massachusetts state certification. Discover more about ICON's certifications, licenses and accreditations.

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