Why Legacy Genomics
Fails Patients
Traditional genomic systems suffer from three critical failure modes that compromise patient care, erode institutional trust, and expose organizations to regulatory risk. Understanding these failures is the first step toward transformation.
of laboratories report audit trail gaps
CAP Survey 2024of variants reclassified within 2 years
ClinVar Analysisaverage cost of regulatory non-compliance
Industry Reportof clinicians distrust genomic uncertainty labels
ACMG SurveyThree Critical Failure Modes
Each failure mode represents a systemic vulnerability that our platform addresses with purpose-built architectural solutions.
Audit Collapse
Traditional genomic systems lack immutable audit trails, creating compliance gaps that erode institutional trust and expose organizations to regulatory penalties.
Consequences
- Regulatory citations and financial penalties
- Loss of accreditation and institutional credibility
- Legal liability from incomplete documentation
- Inability to defend clinical decisions retrospectively
Our Solution
ARCS-Grade Audit Chains
Cryptographic provenance with immutable chain-of-custody from data ingestion to clinical output. Every analytical event is timestamped, hashed, and linked to its predecessor.
- Immutable audit trail with cryptographic verification
- Real-time compliance monitoring across jurisdictions
- Automated regulatory report generation
- Complete chain-of-custody documentation
Uncertainty Mismanagement
Hidden or unlabeled uncertainty in genomic reports propagates clinical risk through the care continuum, undermining informed decision-making and patient safety.
Consequences
- Clinical decisions based on false confidence
- Inappropriate treatment recommendations
- Patient harm from unquantified risk
- Erosion of clinician trust in genomic data
Our Solution
Evidence-Tier Quantification
Algorithmic integrity filters that explicitly quantify uncertainty at every level. Every claim is anchored to verifiable, peer-reviewed sources with confidence intervals.
- Seven-tier evidence classification (ECIA-7)
- Explicit confidence intervals on all predictions
- Dual-source verification requirements
- Suppression of unvalidated claims
Static Interpretation Collapse
Point-in-time reports orphan patient care from evolving evidence. As new research emerges, static interpretations become outdated, leaving diagnoses frozen in outdated science.
Consequences
- Missed diagnoses as evidence evolves
- Outdated treatment recommendations
- Manual reinterpretation burden on laboratories
- Patient care disconnected from current science
Our Solution
Longitudinal Reinterpretation
The Living Patient Signature—continuous monitoring and automatic reinterpretation as new evidence emerges. Patient data remains connected to the latest scientific knowledge.
- Continuous evidence monitoring
- Automatic variant reclassification alerts
- Living patient signature updates
- Proactive clinician notifications
Legacy vs. Living Intelligence
A side-by-side comparison of traditional genomic systems and our living intelligence platform.