Clinical Workflow Overview
EpiClassify integrates seamlessly into clinical practice, providing objective diagnostic insights for ME/CFS and Long COVID. Our system transforms a simple blood draw into actionable clinical information through a streamlined workflow:
Blood Sample Collection
A standard 8.5mL EDTA blood tube is collected from the patient during a routine clinical visit. No special preparation or timing is required.
Sample Processing
The blood sample is processed in a CLIA-certified laboratory to extract DNA and perform methylation array analysis using the Illumina EPIC platform.
EpiClassify Analysis
The methylation data is processed through our advanced pipeline and analyzed by our transformer-based AI model to generate diagnostic predictions and biomarker insights.
Clinical Report Generation
A comprehensive clinical report is generated, providing diagnostic probabilities, key methylation markers, and relevant clinical interpretations for the healthcare provider.
Clinical Decision Support
The healthcare provider integrates the EpiClassify results with clinical assessment and patient history to inform diagnosis and treatment planning.
Clinical Report
The EpiClassify clinical report provides comprehensive diagnostic information in an easy-to-interpret format designed for healthcare providers:
EpiClassify
Patient Information
Diagnostic Results
Key Methylation Markers
| Gene | Function | Methylation | Percentile |
|---|---|---|---|
| NR3C1 | Stress response | Hypomethylated | 95th |
| IFNG | Immune regulation | Hypermethylated | 92nd |
| HLA-DRB1 | Immune function | Hypomethylated | 88th |
| PDK2 | Energy metabolism | Hypermethylated | 85th |
| FKBP5 | Stress response | Hypomethylated | 82nd |
Clinical Interpretation
The patient's epigenetic profile shows a strong ME/CFS signature with characteristic methylation changes in key regulatory pathways:
- Immune Regulation: Altered methylation in HLA-DRB1 and IFNG suggests dysregulation of immune response, consistent with the immunological abnormalities observed in ME/CFS.
- Energy Metabolism: Hypermethylation of PDK2 may contribute to metabolic inefficiencies and energy production impairment commonly reported in ME/CFS patients.
- Stress Response: Hypomethylation of NR3C1 and FKBP5 indicates alterations in the HPA axis function, which may relate to the stress sensitivity and cortisol abnormalities in ME/CFS.
These findings provide objective molecular evidence supporting a diagnosis of ME/CFS and may help guide targeted therapeutic approaches.
Clinical Applications
EpiClassify offers several key applications in clinical practice for ME/CFS and Long COVID management:
Objective Diagnosis
Provides molecular evidence to support clinical diagnosis of ME/CFS and Long COVID, conditions that have historically lacked objective biomarkers.
Disease Differentiation
Distinguishes between ME/CFS, Long COVID, and other conditions with overlapping symptoms, enabling more precise clinical management.
Treatment Guidance
Identifies specific biological pathways affected in individual patients, potentially guiding more targeted therapeutic approaches.
Disease Monitoring
Enables tracking of epigenetic changes over time, potentially providing objective measures of disease progression or treatment response.
Clinical Validation
EpiClassify has undergone rigorous clinical validation to ensure reliability and accuracy in real-world clinical settings:
Multi-Center Validation Study
A prospective validation study across 5 specialized ME/CFS and Long COVID clinics with 250 patients demonstrated robust performance in diverse clinical populations.
Technical Reproducibility
Analytical validation demonstrated high reproducibility across different laboratories, operators, and batches, ensuring consistent results in clinical practice.
Clinical Utility Study
A prospective study evaluating the impact of EpiClassify on clinical decision-making showed significant improvements in diagnostic confidence and management plans.
Physician Feedback
Surveys of 120 physicians who used EpiClassify in clinical practice reported high satisfaction and perceived clinical value.
Patient Experience
EpiClassify is designed to provide a seamless experience for patients while delivering valuable diagnostic insights:
Initial Consultation
The healthcare provider discusses EpiClassify testing with the patient, explaining how epigenetic analysis can provide objective insights into their condition.
Simple Blood Draw
A standard blood sample is collected during a routine clinical visit, requiring no special preparation or additional procedures.
Processing Period
The sample is processed and analyzed, with results typically available within 7-10 business days.
Results Consultation
The healthcare provider reviews the EpiClassify report with the patient, explaining the findings and their implications for diagnosis and treatment.
Personalized Care Plan
Based on the EpiClassify results and clinical assessment, a personalized care plan is developed to address the patient's specific needs.
Patient Testimonials
After years of uncertainty and being told my symptoms were psychosomatic, the EpiClassify test provided objective evidence of my ME/CFS. It was validating to finally have molecular proof of what I've been experiencing.
My symptoms persisted long after my COVID infection, but doctors weren't sure if it was Long COVID or something else. The EpiClassify test confirmed Long COVID and helped my doctor develop a treatment plan that's finally helping me improve.