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.
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
- Purchasing and inventory
- Process control
- Information management
- Documents and records
- Nonconforming event management
- 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.