Test Information

Complete regulatory and performance information for the A1 Diagnosis AMD risk assessment test.

Indication for Use

The A1 Diagnosis test is a qualitative laboratory-developed test for the detection of alterations in native peptide biomarkers associated with retinal pigment epithelium cell death, which are commonly associated with age-related macular degeneration (AMD) risk.

The test is intended for use in adults aged 35 and older who are at risk for developing AMD. Results from this test should be interpreted by qualified healthcare providers in the context of the patient's medical history, clinical presentation, and other diagnostic information.

Test Methodology

The A1 Diagnosis test uses advanced mass spectrometry technology combined with machine learning algorithms to analyze blood samples for specific biomarker patterns associated with AMD risk.

Technology Components:

• Sample Type: Blood (serum or plasma)
• Analysis Method: Mass spectrometry-based biomarker detection
• AI Algorithm: Gradient Boosting Classifier (Model version 11.4/11.5)
• Validation Method: 5-fold cross-validation
• Quality Standards: ISO 13485:2016 compliance planned
• Laboratory Certification: CLIA certification required for commercial launch

Performance Characteristics

Planned Phase 1 Clinical Validation Study

A comprehensive validation study is planned with 240 total samples to meet FDA statistical requirements:

• 60 Early Dry AMD samples
• 60 Intermediate Dry AMD samples
• 60 Wet AMD samples
• 60 Age-matched healthy controls

Study Objectives:

• Validate multi-stage AMD detection capabilities
• Establish comprehensive biomarker panels
• Generate data for FDA De Novo pathway submission
• Demonstrate clinical utility across disease spectrum

Limitations

Important limitations of the A1 Diagnosis test include:

• Not Diagnostic: This test provides risk assessment information only and is not a diagnostic test for AMD. A positive result does not mean you have AMD.
• Detection Limitations: The test may not detect all cases of AMD risk. Some individuals at risk may receive negative results.
• False Positives: The test may produce positive results in some individuals who will not develop AMD.
• False Negatives: The test may produce negative results in some individuals who are at risk or will develop AMD.
• Not a Replacement: This test is not a replacement for comprehensive eye examinations by qualified ophthalmologists or optometrists.
• Clinical Judgment Required: Results should always be interpreted in the context of complete medical history, family history, lifestyle factors, and other clinical findings.
• Validation Status: Large-scale clinical validation with 240 samples is planned but not yet completed.

Result Interpretation

Positive Result (High Risk)

A positive result indicates that biomarker patterns associated with AMD risk were detected in your blood sample. This means:

• You may be at increased risk for developing AMD
• You should consult with an eye care specialist for comprehensive evaluation
• Regular eye examinations and monitoring are recommended
• Preventive measures and lifestyle modifications may be discussed with your healthcare provider

Important: A positive result does NOT mean you have AMD or that you will definitely develop AMD. It indicates increased risk that requires further evaluation.

Negative Result (Low Risk)

A negative result indicates that biomarker patterns associated with AMD risk were not detected at this time. This means:

• Current biomarker levels do not suggest elevated AMD risk
• You should continue with routine eye care as recommended by your healthcare provider
• Regular eye examinations remain important, especially if you have risk factors

Important: A negative result does not guarantee you will not develop AMD. Risk can change over time, and regular monitoring remains important.

Risk Categories

• Low Risk: <33% - Biomarker patterns suggest lower AMD risk
• Medium Risk: 33-66% - Biomarker patterns suggest moderate AMD risk
• High Risk: >66% - Biomarker patterns suggest elevated AMD risk

Who Should Consider This Test?

The A1 Diagnosis test may be appropriate for:

• Adults aged 35 and older concerned about AMD risk
• Individuals with family history of AMD
• People with risk factors such as smoking, obesity, or cardiovascular disease
• Those seeking proactive health monitoring and early risk detection

Regulatory Pathway

A1 Diagnosis is pursuing FDA clearance through the De Novo classification pathway:

• Classification: Class II medical device with special controls
• Regulatory Pathway: FDA De Novo (21 CFR 862.1840 and 886.1100)
• Timeline: 150-day FDA review expected under MDUFA V
• Precedent: IDx-DR (2018) - first autonomous AI diagnostic system approved via De Novo
• Guidance Compliance: Following FDA AI-Enabled Device Software Functions (January 2025) and Good Machine Learning Practice (October 2021)

Quality and Compliance

A1 Diagnosis is committed to the highest quality and regulatory compliance standards:

• Quality Management System: ISO 13485:2016 compliance (in development)
• Laboratory Standards: CLIA certification for commercial laboratory
• Professional Standards: College of American Pathologists (CAP) compliance
• Data Security: HIPAA-compliant data handling and storage

Development Timeline

Current Status: Pre-clinical development phase

Planned Phases:

1. Phase 1 (9-24 months): Pre-clinical validation and FDA consultation
   • 240-sample validation study
   • FDA Q-Submission for De Novo pathway
   • Quality Management System implementation
2. Phase 2 (6-24 months): Clinical validation and regulatory submission
   • Multi-center clinical studies (minimum 3 sites)
   • De Novo classification request submission
   • FDA review process (150-day timeline)
3. Phase 3 (12 months): Commercial launch and market penetration
   • CLIA laboratory certification
   • Medicare coverage determination
   • Healthcare provider training
   • Expected Commercial Availability: Q1 2027