Origins in Academic Research
2018 – 2023
The foundation for A1 Diagnosis began at UC Irvine's Gavin Herbert Eye Institute, where Dr. Mustafa Ozgul conducted six years of specialized research into age-related macular degeneration biomarkers.
- 15 peer-reviewed publications (4 journal articles and 11 ARVO conference abstracts)
- Research focused on AMD biomarkers, mitochondrial-derived peptides (Humanin-G, MOTS-c), and retinal degeneration
- Established the scientific foundation for understanding how dying retinal pigment epithelium cells release specific peptide signatures into the bloodstream years before clinical AMD symptoms appear
From Treatment to Prevention
2024
A critical insight crystallized: AMD care needed to shift from reactive treatment after vision loss to proactive risk assessment before symptoms emerge.
- 169 million Americans aged 35+ face AMD risk with no accessible blood-based screening option
- Emerging AMD prevention therapies advancing through clinical trials created new market opportunity
- Fundamental transformation needed in how AMD care could be delivered
Company Formation & Strategic Direction
January 2024
Dr. Ozgul partnered with Dr. Murat Baday, a Stanford-trained AI/ML expert who previously founded Smartlens Inc. and raised a $6.1M Series A.
- Phased commercialization strategy following proven diagnostic company models
- Phase 1: CLIA certification for initial revenue generation
- Phase 2: Clinical data collection and validation
- Phase 3: FDA De Novo submission with Breakthrough Device Designation
Regulatory Landscape Transformation
March 2025
A federal court ruling on March 31, 2025 fundamentally changed the regulatory environment for laboratory-developed tests.
- Court vacated FDA's LDT Final Rule in its entirety
- Ruling held that laboratory services fall under CLIA jurisdiction rather than FDA device regulation
- Validated A1's CLIA-first strategy for commercialization
- Confirmed that clinical laboratories can develop testing services under CLIA certification
Proof-of-Concept Validation
2025
Initial validation studies demonstrated technical feasibility of the blood-based AMD risk assessment approach.
- 97.8% machine learning accuracy (ROC AUC 0.987) in proof-of-concept studies
- 398 statistically significant biomarkers identified from 12-sample validation
- Research published in Investigative Ophthalmology & Visual Science and International Journal of Molecular Sciences
- Builds on foundation of 15 peer-reviewed publications from UC Irvine
Laboratory Development
Q4 2025 – Present
Current efforts center on establishing CLIA-certified clinical laboratory infrastructure.
- Evaluating high-end mass spectrometry platforms for clinical deployment
- Defining laboratory space requirements and staffing model
- Planning equipment validation protocols
- Target: Q1 2027 for CLIA certification completion
- Strategically timed with Novartis Phase 2 AMD prevention therapy trial completion (October 2026)
Vision: The Proactive Health Era
A1 Diagnosis represents more than a single blood test—it embodies a fundamental shift in healthcare philosophy.
- Building toward a future where disease risk is identified years before clinical manifestation
- Enabling intervention during the critical window when prevention strategies can be most effective
- Positioning as the patient identification platform as AMD prevention therapies advance to market
- Transforming AMD from a leading cause of irreversible blindness into a preventable condition
Platform Technology Potential
The core intellectual property represents a platform approach potentially applicable beyond AMD:
- Native peptide mass spectrometry detects post-translational modifications that snRNA-seq misses
- Applicable to multiple conditions where cell death biomarkers indicate disease risk years before symptoms
- Platform expansion to other disease applications represents future research opportunities
Important Regulatory Information
This test has not been cleared or approved by the US Food and Drug Administration. The test is under development and performance characteristics will be determined through clinical validation studies. Target commercialization as a CLIA-certified laboratory-developed test in 2027. Proof-of-concept accuracy cited represents initial validation with 12 samples and requires expansion to larger clinical studies.