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.