Early Detection. Brighter Futures. Precision in Every Drop
- Revolutionizing Autism Diagnosis with a Simple Blood Test
Introducing Aura-Screen™, the world’s first patented, clinically validated blood test for objective autism spectrum disorder (ASD) screening in children as young as 18 months
2. The Problem We Solve
The Diagnostic Odyssey Ends Here
The Current Path is Broken: The average age of ASD diagnosis is still over 4 years, despite symptoms appearing by 18 months.
Subjective and Lengthy Process: Diagnosis relies on behavioral observations, which are subjective and require long waitlists for scarce specialists.
Critical Delay in Intervention: This delay misses the brain’s most critical window for early intervention, impacting a child’s lifelong potential.
Immense Parental Stress: Families endure a painful, uncertain, and protracted “diagnostic odyssey.”
The Cost of Delay: For every year of delayed intervention, the lifetime cost of care for an individual with autism increases by an estimated $50,000 – $100,000.
3. Our Solution: Aura-Screen
Aura-Screen™ is a patented blood test that detects a specific panel of metabolic and protein biomarkers associated with Autism Spectrum Disorder.
How It Works (The Science):
1. Simple Blood Draw: A standard blood sample is taken from the child.
2. Proprietary Analysis: Our patented algorithm analyzes a panel of key biomarkers linked to neurodevelopmental pathways.
3. Clear, Actionable Result: The test provides a **highly accurate, objective risk score** to aid clinicians in the diagnostic process.
Key Differentiators:
Patented Technology: Fully protected IP with multiple granted patents
Clinically Validated: Peer-reviewed studies demonstrate >90% sensitivity and specificity in a multi-center trial.
Ages 18+ Months: Catches the critical early window for intervention.
Scalable & Accessible: Can be deployed in standard pediatric labs worldwide.
4. The Market Opportunity
A Multi-Billion Dollar Market, Ready for Disruption
Total Addressable Market (TAM): Over 130 million children are born globally each year. In the US alone, over 3 million children are in the primary screening age range annually.
Serviceable Available Market (SAM): Focusing initially on the US and EU, the immediate market includes over 50,000 pediatric clinics and thousands of child development centers.
Compelling Economics: With a projected price point of $400-$600 per test, the initial SAM represents a $2-3 billion annual opportunity.
First-Mover Advantage: Aura-Screen™ is positioned to be the first objective screening tool of its kind, creating a new standard of care.
5. Traction & Validation
From the Lab to the World: Our Proven Path
Patent Status: Granted in the US (US Patent #11,XXXXXX) and Japan (JP Patent #11,XXXXXX). Additional patents pending in key markets.
Clinical Validation: Published findings in [Molecular Psychiatry] involving a cohort of 478 children.
Regulatory Pathway: Active discussions with the FDA for Breakthrough Device Designation. Planned for CLIA-lab launch (Q4 2024) followed by FDA submission.
Key Opinion Leader (KOL) Backing: Endorsed by leading pediatric neurologists and autism researchers from top-tier institutions
6. The Investment Opportunity
Lead the Paradigm Shift in Neurodevelopment
We are seeking $8 Million in Series A Funding to accelerate our path to market.
Use of Funds:
40% – Commercial Scale-Up & Manufacturing.
30% – Final FDA Clinical Trial & Regulatory Submissions.
20% – Commercial Team & Market Development.
10% – IP Expansion & R&D for next-generation panels.
The Vision: To make Aura-Screen™ the global standard of care for early autism screening, and to expand our biomarker platform into other neurodevelopmental conditions.
7. The Team
A World-Class Team with a Proven Track Record
Dr. ????, PhD (CEO): Serial entrepreneur in diagnostics, former VP at [Famous Biotech Co.], 10+ exits.
Dr. ?????, MD, PhD (CSO): Renowned neuroscientist and child psychiatrist from [Top Tier University], lead author of the validation study.
????, MBA (COO): Operations expert with 15 years of experience scaling diagnostic labs and navigating FDA pathways.
8. Investor Call-to-Action
Join Us in Shaping the Future of Child Development
We invite you to learn more about this ground-breaking opportunity to achieve both significant financial returns and profound social impact.
Two Ways to Connect:
1. [Download our Comprehensive Investor Deck]
2. [Schedule a Confidential Call with Our CEO]
Contact: `investors@idiagnostix.com` | All inquiries are held in strict confidence.
9. Footer
Disclaimer: This is for informational purposes only and does not constitute an offer to sell securities.
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Copyright: © 2024 iDiagnostix. All Rights Reserved.
Patents: Aura-Screen™ is a trademark of iDiagnostix. Protected by US Patents US20210033621 and Japan patentJP2021513058.