Gut Microbiome Risk Scoring for Early ASD Assessment

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Solution Overview

Problem

Current methods for diagnosing autism spectrum disorder (ASD) are challenging due to the lack of medical tests, leading to delayed diagnoses, especially in young children, and there is a need for early risk assessment to facilitate effective disease management.

Innovation Solution

A system and method utilizing gut microbiome analysis through DNA sequencing and machine learning to assess the metabolic potential of neuroactive compounds produced by gut bacteria, predicting the risk of ASD and providing therapeutic interventions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If behavioral and developmental observation methods are used for ASD diagnosis, then diagnosis can be made based on patient behavior, but diagnosis is delayed especially in children under four years old due to incomplete speech development and lack of objective medical tests

Engineering Contradiction:
Improvediagnosis accuracyVSAvoiddiagnosis delay
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent introduces gut microbiome composition as an intermediary biomarker to bridge the gap between behavioral observation and definitive ASD diagnosis. By analyzing microbial community structure in gastrointestinal samples, the system provides an objective intermediate assessment that can indicate ASD risk before behavioral symptoms fully manifest, particularly in children under four years old with limited speech development.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent performs preliminary risk assessment through microbiome analysis before definitive ASD diagnosis can be established through traditional behavioral observation. This preliminary action using microbial biomarkers enables early identification of children at risk, allowing intervention to begin before the typical diagnostic delay occurs in toddlers and preschoolers.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If traditional behavioral observation and developmental assessment are used, then diagnosis relies on patient behavior, but many children do not receive final diagnosis until much older when they should have received early intervention

Engineering Contradiction:
Improvediagnosis reliabilityVSAvoidtime to diagnosis
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent employs gut microbiome analysis as an intermediary diagnostic tool that provides more reliable and earlier indication of ASD risk compared to traditional behavioral observation alone. The microbial biomarkers serve as an objective measure that can be detected in gastrointestinal samples, reducing reliance on subjective behavioral assessment and enabling more consistent diagnosis timing across different children.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical/observational system of behavioral assessment with a biochemical analysis system based on microbiome composition. This substitution uses molecular biology techniques to detect and quantify microbial communities, providing a more reliable and less subjective diagnostic approach that can be applied consistently regardless of the child's ability to communicate or exhibit clear behavioral symptoms.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Adaptability or versatility

If no medical test exists for ASD diagnosis, then diagnosis must be based on behavior observation, but this makes diagnosis difficult especially in children with incomplete speech development

Engineering Contradiction:
Improvediagnosis applicabilityVSAvoiddiagnosis difficulty
Core Design Contradiction:
Adaptability or versatilityVSDifficulty of detecting and measuring

Solution Approach 1:

The patent introduces microbiome analysis as an intermediary diagnostic method that is applicable to all children regardless of their speech development or behavioral presentation. This intermediary test bypasses the difficulty of assessing children with incomplete speech development by using microbial biomarkers that can be detected in gastrointestinal samples without requiring the child to communicate or exhibit specific behaviors.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the difficult mechanical process of behavioral observation and developmental assessment with a biochemical testing system. This substitution uses molecular techniques to analyze microbial DNA or RNA from gastrointestinal samples, providing a diagnostic method that is equally applicable and measurable across all children including those with severe speech delays or limited behavioral expression.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS12633376B2System and method for risk assessment of autism spectrum disorder
Publication Date: 2026.05.19 TATA CONSULTANCY SERVICES LTD
  • US12633376B2 patent drawing
  • US12633376B2 patent drawing
  • US12633376B2 patent drawing

AI summary

A system and method for risk assessment of an individual for autism spectrum disorder (ASD) has been provided. The system is using a non-invasive method for risk assessment of the individual, especially children, for ASD through prediction of metabolic potential of the bacteria residing in gastrointestinal tract of the individual. The system is configured to calculate a score, evaluated from the gut bacterial community's taxonomic abundance profile, which is indicative of its metabolic potential for production of a particular neuroactive compound. A set of metabolic pathways harboured by the bacterial community residing in gut has been utilized to develop an ASD diagnosis scheme that, when applied with the conventional screening tests, help in early diagnosis of the ASD. Further, the present disclosure also provides bacterial community based therapeutic approaches that can potentially minimize the side effects through maintaining the healthy cohort of bacteria in gut.