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Executive Summary

v17 update (April 2026): Platform expanded from oncology to preventive health. 19 custom servers (104 tools). PAT003 (preventive CVD) validated April 23, 2026. See ROADMAP.md for full version history.

The Problem

Standard HGSOC workup (BRCA1/2, HRD panel, CT imaging) generates no immunotherapy hypotheses. Manual multi-modal analysis across genomics, spatial transcriptomics, imaging, and clinical data takes an estimated 40 hours and $6,000-9,000 per patient -- making integrated analysis clinically impractical.

The Platform

A 19-server MCP architecture orchestrated by AI (Claude + Gemini) executes automated multi-modal analysis pipelines: oncology patients follow a 5-stage workflow (Data Acquisition → Spatial Deconvolution → Target Profiling → Causal Inference → Report); preventive health patients use a parallel cardiometabolic risk-stratification workflow.

All tools accessible via natural language. Every AI result requires clinician APPROVE/REVISE/REJECT. HIPAA-compliant architecture with Safe Harbor de-identification and 10-year audit trails.

Metrics: 40 hours -> 2-5 hours (production), ~$324-702/patient vs $6,000-9,000 traditional. See Value Proposition for details.

Servers: 19 custom (104 tools) + 6 external connectors — see Server Registry for current counts.


Key Findings (PatientOne -- Synthetic HGSOC)

Three treatment hypotheses unreachable by standard workup:

  1. Personalized neoantigen vaccine -- TP53 R175H generates RMPEAAPPV peptide (IC50 7.8 nM via netMHCpan), strong HLA-A*02:01 binding
  2. NNMT/CAF inhibition -- 18.2% CAF fraction; GEARS predicts NNMT knockdown reduces STAT3/COL3A1 signaling, recovers PRF1/FOXP3 immune markers
  3. Convergent checkpoint blockade -- POLE-corrected TMB 47.3 mut/Mb + spatial CD8 exclusion pattern -> anti-PD-1/CTLA-4 combination rationale

Plus: cross-cancer validation on PAT002 (ER+ breast cancer) with zero code changes.

Clinical details: PatientOne Profile


Investment Tiers

Tier Investment Deliverable Timeline
Pilot $50,000 3 production servers, 100 patients, training 6 months
Production $75,000/year Full 19-server deployment, Epic FHIR, 500 patients 12 months
Multi-Site $150,000 3-5 hospitals, IRB protocol, publication support 18 months

Projected annual savings: ~$313K (100 patients) to ~$1.6M (500 patients). Modeled, pending clinical validation.


Specific Aims Template (for NIH R21 / Foundation Grants)

Aim 1 -- Validate Clinical Utility: Retrospective analysis of 100 ovarian cancer patients. Compare platform recommendations vs. actual clinical decisions. Target: >=80% concordance with molecular tumor board.

Aim 2 -- Assess Scalability: Prospective 500-patient cohort over 12 months. Track compute costs, analysis time, clinician satisfaction. Validate modeled $3,137/patient savings.

Aim 3 -- HIPAA Infrastructure: Epic FHIR integration, Safe Harbor de-identification, 10-year audit logging, institutional security audit.


Validation Status

Three synthetic patients validated end-to-end (no dry_run), April 2026:

Patient Use Case Key Finding
PAT001 HGSOC Stage IV 3 investigational hypotheses (neoantigen vaccine, NNMT/CAF inhibition, convergent checkpoint blockade)
PAT002 ER+ breast cancer PARP eligibility via germline BRCA2 despite HRD 35 < myChoice threshold
PAT003 Preventive CVD 3 evidence gaps missed by standard lipid panel + Helix Tier 1 genetic screen: Lp(a), APOE, CAC score

Real patient data validation (30–50 patients, matched clinical outcomes) is the proposed next step.


Risk Assessment

Risk Level Mitigation
Technical LOW Auto-scaling, comprehensive error handling, 223+ tests
Compliance LOW Built-in de-identification, audit logging, VPC isolation
AI Vendor MEDIUM Dual-provider (Claude + Gemini), MCP servers are provider-agnostic
Adoption MEDIUM-HIGH Phased rollout, Streamlit UI for clinicians, Jupyter for bioinformaticians

Contact: Lynn Langit Status: Ready for Funding Review See also: Demo & Pitch | Value Proposition | Server Registry