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Research & Development

Functional medicine evolves quickly. New biomarkers, novel test panels, and advanced analytical methods appear every year — but turning these ideas into validated, reproducible, and clinically meaningful assays is challenging. Proper R&D requires structured methodology, high-quality data, and consistent evaluation to ensure results are trustworthy for practitioners and patients.

The IAFMD supports laboratories, clinicians, and research teams throughout this development journey. We help you design, validate, and refine functional medicine tests in line with the IAFMD Standards Framework for Accreditation. Whether you’re creating a new organic acids panel, validating hormone metabolites, developing genomic assays, or refining functional biomarkers, we bring scientific discipline and real-world clinical insight to your R&D.

Our R&D Support Services

Assay Development & Validation

  • Analytical validation (precision, accuracy, sensitivity, specificity)
  • Biological validation using diverse functional medicine sample sets
  • Inter-laboratory comparison studies
  • Reference range development for practitioners (age, sex, symptom-based, lifestyle-based)
  • Method optimisation for dried blood spot, serum, plasma, urine, stool, saliva and breath testing

Functional Biomarker Development

We support labs working on:

  • Hormone metabolites & endocrine panels
  • Organic acids & metabolic profiling
  • Nutrient status & micronutrient testing
  • Inflammation & immune function biomarkers
  • Environmental toxin panels (heavy metals, pollutants, mycotoxins)
  • Food sensitivity & immunological assays
  • Oxidative stress & mitochondrial function markers
  • Cardiometabolic risk markers
  • Functional genomics & SNP interpretation frameworks

Pilot Studies & Clinical Cohorts

  • Study design and feasibility assessment
  • Creation of population cohorts relevant to functional medicine
  • Testing protocols for multi-sample or multi-matrix assays
  • Collection kit design (saliva, urine, stool, blood spot, breath)
  • Real-world pilot groups for practitioner case evaluation

Bioinformatics & Data Analysis

  • Pattern recognition and biomarker clustering
  • Multi-system data integration (endocrine, metabolic, immune, digestive, detoxification pathways)
  • Algorithm development for functional interpretation
  • Reference population modelling
  • Longitudinal data analysis for chronic-condition tracking

Reference Laboratory & Independent Review

  • External evaluation of your in-house test panels
  • Cross-platform comparison (e.g., LC-MS, GC-MS, immunoassays)
  • Qualitative and quantitative verification
  • Sample stability testing under real shipping conditions
  • Third-party performance assessment for clinical credibility

Documentation & Scientific Reporting

  • Method development documentation
  • Validation studies aligned with IAFMD accreditation requirements
  • Safety, risk, and quality documentation
  • White papers, validation summaries, and clinical interpretation guidance
  • Practitioner-facing reporting frameworks

Quality & Compliance Integration

  • R&D processes aligned with global quality principles (CLIA-aligned, ISO-informed)
  • Ongoing QA monitoring during test development
  • Troubleshooting low-performing biomarkers
  • Establishing post-launch performance metrics

Clinical & Practitioner Collaboration

  • Practitioner pilot groups for new panels
  • Case-study driven refinement of interpretation
  • Symptom-driven test development strategies
  • Development of clinical reporting narratives and functional insights

Laboratory Infrastructure & Method Support

  • Optimising workflows for hormone, metabolic, toxin, immune and genomic assays
  • Selecting the right platforms (LC-MS, GC-MS, ELISA, PCR, NGS, spectrometry)
  • Specimen handling optimisation for functional biomarkers
  • LIMS integration and data-flow design

Who We Support

The IAFMD partners with:

  • Functional medicine laboratories
  • Diagnostic development companies
  • Research institutions and universities
  • Biological and analytical chemistry labs
  • Healthcare practitioners co-developing new tests
  • Innovation teams building functional biomarkers
  • Reference labs requiring independent validation