Validation Services
Method Development and Validation
Biomarkers and complex clinical assays are recognized as essential tools for the development of therapeutics, allowing improved and better-informed clinical trial design through indicators of target engagement and those that enable patient stratification. Our Team can help design and validate new assays in our CAP/CLIA laboratory, undertake method transfers or migration modification of existing novel methods.
Our expert Board-certified pathologist and PhD scientific teams are on hand to provide protocol consulting, Biomarker selection / consultation, Biomarker assay development, Companion diagnostic selection / validation, access to pathology tissue and biobank resource, and support all aspects of your Phase I, II, III specialty laboratory testing.
IVD/CDx Study Support
Our Expertise in CAP/CLIA molecular diagnostics, pathology, informatics, innovative solutions, and technologies makes us an ideal choice to meet your IVD/CDx testing needs. We have over two decades of experience with major instrument and diagnostic reagent manufacturers in providing support for IVD/CDx studies. Our services include.
- Assay validation for 510K/PMA data collection
- Presentation of data to the FDA Advisory Committee
- Partner for Companion Diagnostic Development
- Platform and Assay Correlation
- Clinical Interpretive Expertise and Result Consultation
- Method Development and Validation