Biomarker & CDx

Biomarker Discovery and Companion Diagnostics

With a deep understanding of clinical development, diagnostic development and regulatory requirements, we can strategically partner with clients throughout the entire process of biomarker discovery and CDx Development.

  • Discovery
    We have extensive experience in discovery of new preclinical biomarkers for research and analyzing known clinical biomarkers for personalized treatments and companion diagnostics.
  • Quantification and Validation
    As biomarkers have become an integral part of drug development, a rigorously validated biomarker is critical for bringing effective therapeutics to market. We ensure compliance with standards established by regulatory and accrediting bodies, including CAP, CLIA, and CLEP. We employ a “12 Point Quality System”, namely
    • Organization
    • Personnel
    • Equipment
    • Purchasing and inventory
    • Process control
    • Information management
    • Documents and records
    • Nonconforming event management
    • Assessment
    • Continual improvement
    • Customer service
    • Facilities and safety
  • Clinical Applications
    We have developed CLIA-certified, CAP-accredited lab tests for nearly 600 genetic biomarkers ready to use for clinical research and patient testing.

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Learn more about our Next Generation Sequencing services:

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