Precision diagnostics leader fast-tracks biomarker discovery to boost early detection performance

The company set out to build next-generation diagnostic panels using AI for biomarker discovery and validation—integrating genomic, proteomic, and metabolomic signals to improve early detection while staying audit-ready for FDA/CLIA.

• Integrate multi-omics data into a unified discovery platform
• Improve diagnostic accuracy (sensitivity/specificity) at early stages
• Shorten discovery→validation timelines without sacrificing rigor
• Expand into new disease areas with compliant workflows

Existing assays underperformed for early-stage disease, ML models overfit training data, and validation cycles were slow—limiting launch cadence and physician adoption versus competitors.

• Liquid biopsy tests showed 68% sensitivity in early cancers
• Multi-omics integration captured only 34% of disease signatures
• Prior ML approaches had 81% overfitting on training cohorts
• Biomarker validation required 18 months, delaying launches
• Clinical utility studies achieved 45% physician adoption
• Competitor tests posted 25% better head-to-head performance

CleverX assembled a cross-disciplinary team to operationalize multi-modal ML, robust feature selection, and staged clinical validation—baked into CLIA/CAP-compliant lab workflows and FDA-ready documentation.

Expert recruitment:

• 14 specialists: 5 genomics experts, 5 clinical biochemists, 4 bioinformaticians
• Avg 8 years in diagnostics; FDA submission experience
• Depth in ctDNA, proteomics, and clinical validation
• CLIA regulations and 510(k) process familiarity

Technical framework:

• Multi-modal integration across 5 data types
• Feature selection reducing 10,000 → 50 optimal markers
• Validation framework using 3 independent cohorts
• Clinical decision support algorithms for physician use

Quality protocols:

• Analytical validation per CLSI guidelines
• Clinical validation with 1,000-patient cohort
• CAP/CLIA-compliant laboratory workflows
• Physician reports aligned with FDA expectations

A sprinted rollout moved from data harmonization to assay development and clinical validation—closing the loop between signal discovery and real-world performance.

Week 1: Data integration and cohort analysis

• Integrated 10,000 multi-omics profiles
• Linked outcomes to biomarker associations
• Down-selected 500 candidate markers

Weeks 2-3: Biomarker discovery and selection

• ML pipeline delivered 50-marker signature
• Validated across 3 cancer types
• Achieved 91% specificity while maintaining high sensitivity

Weeks 4-5: Assay development and optimization

• Built multiplex assays for selected markers
• Protocol CVs driven below 10%
• Validated pre-analytical variables

Week 6: Clinical validation and regulatory planning

• Tested 500 clinical samples confirming performance
• Prepared FDA pre-submission package
• Finalized clinical utility study design

A tight feedback loop between bioinformatics, wet lab, and clinical teams tuned thresholds for precision over volume, improving signal fidelity without physician burden.

Efficiency gains:

Faster path from discovery to clinical proof.

• Biomarker discovery time cut 18 → 7 months
• Assay development cycles down 46%
• Clinical validation accelerated 53%
• Lab throughput improved 38%

Quality Improvements:

Sharper early detection with stable assay performance.

• Early-stage sensitivity up 42% to 89%
• 95% specificity maintained across cancer types
• Indeterminate results reduced 12% → 4%
• Reproducibility improved (CVs < 8%)

Business impact:

Performance translated into growth and funding leverage.

• Entry enabled into $2.8B early detection market
• $4.3M in research grants secured
• Test revenue up 34% on improved accuracy
• $1.6M development cost savings from efficient discovery

Strategic advantages:

A scalable, defensible diagnostics platform.

• Biomarker database spanning 50,000 characterized samples
• Multi-omics platform expandable to 10 diseases
• Proprietary algorithms with 4 patents pending
• Clinical network of 50 participating centers

The company's innovation received FDA breakthrough device designation.