1
Disease Stage Progression
4 groups spanning the full AMD spectrum — from healthy baseline through advanced disease — collected from 3+ clinical centers (n=240)
Baseline
Healthy Controls
n=60
No retinal findings
→
The Critical Window
Asymptomatic Early AMD
n=60
Drusen present, ZERO vision symptoms
Proves biomarkers rise BEFORE symptoms
→
Symptomatic
Symptomatic Early AMD
n=60
Vision changes present
→
Advanced
Advanced AMD
n=60
Dry & Wet AMD
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Why Cross-Sectional Validation Works
FDA & CLIA-Accepted Standard
Used by Cologuard (FDA PMA) and CancerGuard (CLIA LDT) — both Exact Sciences products that validated via cross-sectional case-control studies
Captures Years of Biology
Drusen deposits represent 5–10+ years of accumulated molecular changes, meaning a single-timepoint blood draw captures the cumulative biological signature of disease progression
3
Regulatory Precedent: Exact Sciences Success Stories
Similar Study Design as Ours
CancerGuard (Exact Sciences)
CLIA-certified LDT launched at $689 with nationwide Quest Diagnostics access
Case-control design: compared patients with existing cancer vs. healthy controls at a single timepoint. Same cross-sectional validation approach as our 240-sample AMD study. No longitudinal data required for CLIA certification.
Cologuard (Exact Sciences)
FDA PMA-approved via prospective, cross-sectional DeeP-C trial — $2.1B+ annual screening revenue
Prospective screening of 10,000 asymptomatic patients with colonoscopy as reference standard at a single timepoint. No longitudinal progression data required for FDA approval.
Alzheimer's Biomarkers
Cross-sectional validation, later confirmed elevated 10–20 years pre-symptoms
PSA & Oncotype DX
Validated via single-timepoint biomarker comparison
4
Investor Questions
Why not longitudinal data?
Cross-sectional validation is the industry standard. CancerGuard (case-control design like ours, CLIA LDT at $689) and Cologuard (FDA PMA-approved, $2.1B+ revenue) both used single-timepoint validation. Our asymptomatic group proves biomarkers rise before symptoms. Longitudinal studies follow post-launch — standard two-phase approach used by all screening tests.
Can you predict AMD before any signs?
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Our validation study is specifically designed to answer this by including an asymptomatic early AMD cohort (drusen present, zero vision symptoms).
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Our proof-of-concept demonstrates the platform can detect biomarker alterations associated with AMD.
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Our 240-sample validation study follows the same case-control, cross-sectional design Exact Sciences used for CancerGuard.
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CancerGuard's test development study analyzed 21 different cancer types and 4 stages in 729 samples, resulting in 1 to 48 samples per cancer type per stage.
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Our study focuses on a single disease with 60 samples per group, providing significantly greater statistical power per condition.
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Cohort sizes determined by power analysis requiring ~13 samples per group for statistical significance. We are using nearly 5x that threshold.
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CancerGuard launched as a CLIA LDT at $689 with nationwide Quest Diagnostics access (September 2025).
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Full CancerGuard clinician brochure available in data room.
How reliable is "asymptomatic early AMD"?
Diagnosed via dilated fundus exam and OCT imaging — the clinical gold standard. Drusen deposits are objective physical findings validated by retinal specialists, making this classification highly reliable.