Reference Laboratory for the In Vitro Diagnostics (IVD) Industry

• FDA-aligned testing for sample stability, common analytical interferences, and assay robustness.
• Validation and verification studies for new and existing assays across multiple platforms.
• Support for FDA registration studies and IVD clinical trials.

Assay and Biomarker Testing Capabilities

• Full-service biomarker core lab for industry and NIH-funded clinical trials.
• High-throughput testing of commercial immunoassays and custom ELISA-based research assays.
• Multi-platform availability for assay flexibility and scalability.

Regulatory and Study Infrastructure Support

• Protocol and case report form (CRF) development tailored to regulatory and operational needs.
• Ethics Committee and Institutional Review Board approval of Studies.
• Coordination and management of expert independent endpoint adjudication committees.

Clinical Sample Collection and Phenotyping

• Leverages the University of Maryland Medical System, which serves more than two million members of a diverse population and features care settings that include urban, suburban and rural environments.
• Access to deeply phenotyped cohorts from healthy individuals to those with chronic and acute conditions.
• Prospective blood collection and processing in emergency, inpatient, outpatient, and specialty clinic environments.

Knowledge Promulgation

• Our laboratory directors can lead or collaborate with consortium to produce peer-reviewed publications and public presentations of study design, development and validation of analytical methods and clinical interpretation of results.