Blood Test

The Test

This test represents a significant advancement in biomarker-driven assessment and may, in future, complement behavioural and developmental screening approaches used by clinicians worldwide.

Revolutionizing Autism Diagnosis with a Simple Blood Test

Introducing ASDproteinpattern, the world’s first patented, clinically validated blood test for objective autism spectrum disorder (ASD) screening in children as young as 18 months

The Diagnostic Odyssey Ends Here

The Problem We Solve

The Current Path to Autism Diagnosis: 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.

Our Solution: ASDproteinpattern blood test

ASDproteinpattern is a blood test only applicable to post-natal testing of infants and children to assess the presence of autism. The test outcome is available within one week.

How It Works (The Science):

Simple Blood Draw: A standard blood sample is taken from the child.
Proprietary Analysis: Our patented tests is based on the measurement of 4 modifications of plasma proteins combined in a diagnostic algorithm.
Clear, Actionable Result : It is a screening test: a positive outcome indicates autism is highly likely and referral to a child development expert for confirmation is required; a negative outcome indicates autism is highly unlikely and no further action is required.

Key Differentiators

Patented Technology : Fully protected IP with multiple granted patents
Clinically Validated:Peer-reviewed studies demonstrate ≥80% sensitivity and specificity, achieving 83% accuracy 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.

A Multi-Billion Dollar Market, Ready for Disruption

The Market Opportunity

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.

Traction & Validation

Patent Status: Granted in the US (US Patent US20210033621) and Japan (JP Patent JP2021513058). Additional patents pending in EU and UK.

Discovery phase study:Identification of 4 key analyte features in algorithm; accuracy 88%, sensitivity 92% and specificity 84%. Published in Molecular Autism (>33,000 article accesses).

Validation phase study: Multi-center international involving a cohort of 478 children; accuracy 83%, sensitivity 94%, specificity up to 76%. Published in Molecular Psychiatry (>6000 articles accessed since 2024)

Pathway to regulatory approval: seeking regulatory approval in the ,USA, Japan and the EU/UK.

Key Opinion Leader (KOL) Backing: Endorsed by leading pediatric neurologists and autism researchers from top-tier institutions

The Investment Opportunity

Join in the journey for this exciting advance in the diagnosis of autism

We are currently seeking Series A Funding from investors/partners to accelerate our path to market.

Vision: To make “ASDproteinpattern” the global standard of care for early autism screening, and to expand our biomarker platform into other neurodevelopmental conditions.

Call-to-Action

Join Us in Shaping the Future of Autism Diagnostics

We invite you to learn more about this ground-breaking advance in screening for autism by a simple highly accurate and widely applicable blood test. Come and join us on this exciting and rewarding journey of innovation

Contact:  info@idaignostix.com