Age-related Macular Degeneration (AMD) is the #1 cause of vision impairment and severe vision loss among elderly people in the United States.
Our groundbreaking solution enables disease risk determination years before vision loss.
Market Opportunity: Inspired by the Exact Sciences model ($20.0 billion market value, $2.76 billion annual revenue, currently planned for acquisition by Abbott), we are positioned to capture significant market share in the high-impact healthcare sector.
Current detection methods identify the disease only after irreversible damage has occurred, when treatment options are limited and costly.
AMD progresses through four distinct stages: Early Stage (mild central vision changes), Intermediate Stage (increasing central vision loss), Advanced Dry AMD (significant central vision loss), and Advanced Wet AMD (severe central vision loss with rapid progression). Current screening methods detect the disease far too late in this progression.
Critical Challenge: Progressive and irreversible vision loss occurs over time. When vision problems become apparent, the damage is permanent and irreversible.
Chronic diseases develop silently over years before symptoms appear. This creates a critical window of opportunity for early intervention.
Navigate through the five interactive visualizations below to explore disease progression and early detection opportunities.
Breakthrough Results in Native Peptide Biomarker Discovery
Statistically significant potential biomarkers identified (p<0.05)
High-confidence biomarkers with p<0.003 and Fold Changes >10
Attomole sensitivity detection validates our technical approach
Results demonstrate feasibility for larger validation studies
Statistical Methods: Statistical analyses were performed using Python Version 3.12.4 with libraries (NumPy, SciPy, Pandas, and Matplotlib) and GraphPad Prism Software. The Shapiro-Wilk test was used to determine the distribution of continuous variables in each group. For comparing two groups, Welch's t-test was applied if both groups showed normal distributions, while the Mann-Whitney U test was used if at least one group had a non-normal distribution. To control for multiple comparisons, we applied the Benjamini-Hochberg procedure with a False Discovery Rate (FDR) of 1%.
Power Analysis & Sample Size Calculation: Based on our proof-of-concept study data, power analysis (Cohen's d effect size calculations) was performed. A sample size of 60 subjects per group will be needed to provide >90% power to detect significant differences between groups (alpha = 0.05). Groups are Age-matched Older Healthy Subjects, Early Dry AMD, Late Dry AMD, Wet AMD. For the full validation study, we plan to enroll 240 total samples to ensure robust statistical power across multiple biomarker comparisons.
Data Visualization: Volcano plots were generated using Matplotlib and Seaborn libraries, highlighting significantly regulated peptides (p < 0.05, |log2FoldChange| > 2). These visualizations demonstrate clear separation between biomarker expression levels in AMD patients versus healthy subjects, validating the diagnostic potential of our platform.
Early Detection Window: This visualization demonstrates how diseases progress gradually over many years. Our blood-based risk assessment platform can detect biological changes during the early phase—years before traditional diagnostic methods identify symptoms—enabling timely intervention when treatment is most effective.
The current standard of care is symptom-driven—people seek treatment only after vision loss occurs.
Our platform enables early risk assessment through a simple blood test during routine family doctor visits.
Our proof-of-concept study demonstrates breakthrough results in identifying native peptide biomarkers for wet AMD detection and risk assessment.
Statistically significant potential biomarkers identified (p<0.05)
High-confidence biomarkers with p<0.003 and Fold Changes >10
Attomole sensitivity detection validates our technical approach
Results demonstrate feasibility for larger validation studies
Our business model is inspired by the highly successful Exact Sciences model, which achieved a $20.0 billion market value and $2.76 billion annual revenue through blood-based diagnostic tests. Exact Sciences is currently planned for acquisition by Abbott.
Exact Sciences Analysis - 2025 Growth Strategy
$315M+ Adjusted EBITDA in 2024 represents earnings before interest, taxes, depreciation and amortization, adjusted for non-recurring items. 44% annual growth demonstrates strong operational performance and improved profitability compared to 2023.
In US, Medicare covers the cost of tests performed before disease onset. Our AMD risk assessment test can also be covered after necessary procedures.
✓ Regulatory pathway interest
✓ Scientific community interest
✓ Commercial distribution interest
Market Calculation: 169.1 million target population × $250 test price = $42.3 billion total addressable market
📋 Market Sizing Methodology: Bottom-up analysis using U.S. Census Bureau demographic data, CMS healthcare engagement statistics, AMD risk factor prevalence studies (NEI, AAO), and insurance coverage rates. SAM reflects serviceable market accounting for insurance coverage, healthcare access, and proactive health engagement patterns.
Conservative projections show steady growth from market launch to 1% market penetration, with revenue scaling to $400M+ by Year 5 after initial clinical launch.
| Year | Market Share | Annual Tests | Estimated Revenue |
|---|---|---|---|
| Year 1 | %0.02 | 50,000 | $12.5M |
| Year 2 | %0.1 | 200,000 | $50M |
| Year 3 | %0.3 | 500,000 | $125M |
| Year 4 | %0.6 | 1,000,000 | $250M |
| Year 5 | %1.0 | 1,600,000 | $400M |
Our commercialization strategy leverages the CLIA Laboratory-Developed Test (LDT) pathway, following the proven model established by Exact Sciences for rapid market entry while maintaining high quality standards.
Our AI-based blood test will be commercialized as a CLIA-certified Laboratory-Developed Test (LDT), enabling faster market entry without the lengthy FDA approval process. This approach follows the successful model of Exact Sciences' Cancerguard multi-cancer detection test.
Regulatory Precedent: Exact Sciences launched Cancerguard as a CLIA LDT in 2024, demonstrating the viability of this pathway for AI-powered diagnostic blood tests. This precedent validates our commercialization strategy.
Our laboratory will meet all requirements for high-complexity clinical testing:
Following the March 2025 court ruling that vacated FDA's LDT Final Rule, laboratory-developed tests remain under CLIA oversight rather than FDA regulation. This provides a faster, more cost-effective path to commercialization while maintaining rigorous quality standards.
Timeline Advantage: CLIA LDT pathway enables commercial launch in Q1 2027 - significantly faster than the 2-4 year FDA approval process. This allows us to reach patients sooner while generating revenue to support future regulatory submissions if desired.
Our structured three-phase development approach provides systematic progression from validation to CLIA-certified commercial launch.
Each phase has clear milestones targeting Q1 2027 commercial launch.
ResearchDx is our regulatory consulting partner providing comprehensive CLIA certification and CAP accreditation support. Their expertise enables efficient laboratory setup and ensures compliance with all state and federal requirements.
Precedent: Following the proven Exact Sciences Cancerguard model - a CLIA LDT that successfully launched without FDA approval. The CLIA pathway provides faster time-to-market (Q1 2027) while maintaining rigorous quality standards through CAP accreditation and state licensing.
Our comprehensive development pipeline showcases multiple risk assessment platforms across various medical conditions, with AMD as our flagship product leading the way.
Transforming preventive healthcare across multiple therapeutic areas
Strategic Advantage: Our development pipeline positions A1 Diagnosis as a comprehensive platform company rather than a single-product venture. This multi-platform approach provides significant competitive advantages, diversified revenue streams, and enhanced investor value proposition.
Our experienced leadership team combines deep scientific expertise with proven entrepreneurial success in health innovation.
Competitive Advantage: Our team offers a unique combination in medical research, technology commercialization, fintech experience and health innovation. With proven startup successes and strong industry connections, we have an ideal team structure to bring the AMD risk analysis platform to market.
Comprehensive analysis of the AMD diagnostics market reveals a unique opportunity: while 8 well-funded AI imaging companies are targeting AMD detection, there are zero competitors in blood-based early risk assessment.
After extensive competitive research, no startups founded after 2015 are developing blood-based AMD risk assessment tests. While academic research has identified promising biomarkers from Mass Eye and Ear, Cleveland Clinic, and multiple institutions, none have been commercialized. This represents a massive white space opportunity.
Investment Opportunity: This investment opportunity represents the convergence of significant unmet medical need, proven technology platform, experienced leadership, and clear regulatory and reimbursement pathways.
Below you can see an example of blood analysis results related to eye disease.
Demo Explanation: This demo screen shows the user interface of our AMD risk assessment platform that will be applied to real patients. After blood analysis results are processed by the AI algorithm, patients and doctors will receive this type of clear risk assessment.
Comprehensive analysis of Exact Sciences Corporation, a proven diagnostic company following the business model we aim to emulate for AMD risk assessment.