Custom Assay Design & Validation
Custom Assay Design & Validation involves developing tailored analytical, biological, molecular, and functional assays engineered to evaluate the unique characteristics of your material, medical device, therapeutic, diagnostic platform, or research system. Because no two products behave identically, customized assays ensure that mechanisms of action, biological responses, safety attributes, and performance endpoints are accurately measured under conditions that reflect real-world use.
Materials Metric designs, optimizes, and validates assays to meet regulatory expectations, scientific rigor, and industry standards, supporting R&D, preclinical evaluation, QC/QA programs, and translational research.
Custom Assay Design & Validation Can Achieve
Our tailored assay frameworks help characterize:
Biological responses (cell viability, activation, toxicity, inflammation)
Functional behaviors (mechanical function, degradation, drug release, antimicrobial efficacy)
Molecular performance (gene expression, biomarker changes, protein interactions)
Chemical or material interactions (extractables, leachables, surface reactivity)
Diagnostic accuracy (sensitivity, specificity, LOD/LOQ, cross-reactivity)
We also create assays for specialized or emerging applications such as antimicrobial materials, regenerative medicine, nanomaterials, drug-device systems, immunomodulatory platforms, and functional coatings.
Types of Custom Assays We Develop
1. Cell-Based & Biological Assays
Viability, proliferation, cytotoxicity (MTT, ATP, LDH, etc.)
Inflammatory and immune response assays
Cell adhesion, migration, and morphology assays
Barrier function (TEER) and permeability assays
2. Molecular & Biomarker Assays
qPCR-based gene expression
Protein quantification via ELISA, multiplex panels
Microbial detection and host–pathogen interaction assays
3. Functional & Performance Assays
Drug release kinetics
Surface activity and biointerface assays
Antimicrobial and anti-biofilm activity
Mechanical, degradation, or wear-related responses
4. Chemical & Analytical Assays
Stability and impurity tracking
Extractables and leachables profiling
Degradation product monitoring
Material compatibility or reactivity
5. Diagnostic Assay Development
Rapid detection formats
Molecular diagnostic prototypes
Antibody/antigen binding characterization
Lateral flow or microfluidic diagnostic system evaluation
Custom Assay Development Workflow
1. Problem Definition & Assay Scoping
Identify biological, chemical, or functional endpoints
Define assay format, performance expectations, and regulatory considerations
2. Assay Design & Prototype Development
Selection of biological models, biomarkers, analytical platforms, or detection technologies
Development of test conditions, workflows, and endpoints
3. Assay Optimization
Determination of ideal concentrations, time points, controls, and reagents
Optimization of sensitivity, dynamic range, and reproducibility
4. Validation & Documentation
Full validation per regulatory and scientific standards
Preparation of validation reports suitable for regulatory submission
5. Technology Transfer (If Required)
SOP development
Training of client teams
Support with implementation in GLP/GMP settings
Why Choose Materials Metric
Materials Metric provides scientifically rigorous, fully customized assay development backed by analytical and biological expertise.
We offer:
• ISO 9001:2015 accredited workflows
• End-to-end assay design, optimization, and validation
• Deep expertise in biomaterials, diagnostics, and cellular systems
• Regulatory-aligned validation for FDA/ISO submissions
• Fast turnaround with expert scientific guidance
Your assay will be fit-for-purpose, validated, and ready for scientific or regulatory use.
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