Laboratory Capabilities
CLIA-certified clinical laboratory providing integrated assay development, validation, and clinical testing for biotech, diagnostic, and CRO programs.
CLIA-Certified Laboratory | Integrated Diagnostic Services | FDA Submission Support
Scientific & Technical Capabilities
Custom ELISA, multiplex immunoassay, and ligand-binding assay development supported by full analytical validation. Assays are designed for sensitivity, specificity, and matrix compatibility across serum, plasma, tissue, and other biological samples. Development includes reagent optimization, calibration curve design, and robustness studies for research and clinical applications.
PCR, qPCR, RT-PCR, and next-generation sequencing assay development and validation. We support both qualitative and quantitative molecular testing with established workflows for nucleic acid extraction, amplification, and detection across diverse sample types. Services include assay optimization, multiplex panel development, and performance characterization.
Biomarker discovery, screening, and validation services to support diagnostic and translational research programs. We develop and evaluate biomarker panels across defined patient cohorts, supporting early-stage discovery through clinical validation and diagnostic development.
Comprehensive analytical validation studies including sensitivity, specificity, precision, linearity, and reproducibility. Method comparison and verification studies are designed to support regulatory submissions, clinical studies, and deployment in laboratory environments.
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CLIA-Certified Clinical Laboratory
Quality systems built for diagnostic excellence
Regulatory Compliance Framework
Our laboratory operates under CLIA certification with a robust quality management system designed for high-complexity diagnostic testing. We maintain controlled processes, validated methods where applicable, and comprehensive documentation to support accuracy, traceability, and regulatory readiness.
Quality Assurance & Control
Our quality systems are built to ensure reliable and reproducible results. We implement structured quality control procedures, maintain detailed standard operating procedures, and perform ongoing training and competency assessments to support consistent laboratory performance.
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Central Laboratory Services
Full-service central laboratory support for multi-site clinical studies, with standardized testing workflows, specimen management, and data reporting designed for regulatory compliance. Our laboratory ensures consistency across study sites with validated methods, controlled processes, and complete audit-ready documentation.
Companion Diagnostics Support
Development and validation of companion diagnostic assays aligned with therapeutic programs. We work with sponsors to define assay requirements, execute analytical and clinical validation studies, and support regulatory documentation for companion diagnostic submissions, including bridging and concordance studies.
Clinical Study Testing
High-complexity clinical testing services supporting Phase I–IV studies. We provide validated biomarker, safety, and efficacy testing with defined turnaround times, quality-controlled workflows, and real-time data reporting to support clinical decision-making and study timelines.
Specimen Processing & Biobanking
Standardized specimen processing and biorepository services with full chain-of-custody tracking and temperature-controlled storage. Our infrastructure supports longitudinal studies, retrospective analyses, and long-term sample preservation with validated handling procedures.
Data Integration & EDC Compatibility
Seamless integration with sponsor electronic data capture (EDC) systems and laboratory information management systems (LIMS). We provide validated data transfer processes, secure reporting, and customizable data outputs aligned with study protocols and regulatory requirements.
Accelerating Regulatory Pathways
Comprehensive regulatory support designed to move your diagnostic program from development through submission. Our team provides structured analytical validation, clinical study support, and documentation aligned with FDA expectations for 510(k), PMA, and laboratory-developed test pathways.
Structured analytical and clinical validation designed to support regulatory submissions, including study design, data analysis, and documentation.
End-to-end support for laboratory-developed test implementation aligned with CLIA requirements and state regulatory frameworks.
Operational systems, validated processes, and documentation frameworks designed to support inspection readiness and long-term scalability.
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Why Specialty Laboratories
We combine scientific expertise with structured laboratory operations to support diagnostic and clinical programs with consistency and clarity.
Scientific Partnership
Our team works as an extension of your organization, supporting assay design, validation strategy, and study execution with a focus on practical, results-driven development.
Operational Reliability
We operate with defined workflows, validated processes, and clear communication to ensure consistent execution across all projects.
Your Laboratory Partner for Diagnostic Excellence
Specialty Laboratories supports programs from early assay development through clinical testing and validation. Our flexible engagement model allows us to function as a central laboratory, development partner, or extension of your internal team, depending on your program needs.
Advance Your Diagnostic or Clinical Program
Partner with Specialty Laboratories for CLIA-certified testing, assay development, and clinical study support. We provide flexible laboratory services designed to support programs from early development through validation and implementation.
Confidential project discussions available