Microbial Biomarker Risk Assessment for Preterm Delivery

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Solution Overview

Problem

Current methods for preterm delivery risk assessment are either invasive or minimally invasive and provide results too late in pregnancy to allow for effective preventive measures, lacking accuracy in early detection and being unsuitable for asymptomatic cases.

Innovation Solution

A method involving the collection of biological samples (stool or saliva) for microbial DNA extraction, followed by quantitative PCR to determine microbial marker sequences, and a machine learning model to assess preterm delivery risk, enabling early and non-invasive risk assessment and personalized recommendations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional techniques for PTD risk assessment are used, then diagnostic results can be obtained, but the results are provided too late in pregnancy to allow for effective preventive measures

Engineering Contradiction:
Improvetiming accuracy of risk assessmentVSAvoidtime available for preventive measures
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent applies preliminary action by detecting microbial markers in stool or saliva samples during the first or second trimester of pregnancy, before the late second or third trimester when conventional methods provide results. This early detection enables preventive measures to be taken well before preterm delivery would occur, resolving the time loss problem by performing assessment actions in advance.

Inventive Principle:
Principle #10Preliminary action

2Measurement precision

If invasive or minimally invasive methods are used for PTD risk assessment, then diagnostic results can be obtained, but the methods cause discomfort or risk to the subject

Engineering Contradiction:
Improveaccuracy of PTD risk detectionVSAvoidinvasiveness and discomfort to pregnant subject
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent uses stool or saliva samples as intermediary media to detect microbial markers associated with preterm delivery risk. Instead of directly invading the uterus or cervix for sampling, the method uses these accessible body fluids as intermediaries that contain relevant microbial information, thereby achieving accurate risk detection without causing discomfort or harm to the pregnant subject.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If existing PTD risk assessment procedures are used, then diagnostic results are provided in late stages, but little time remains for subjects to take precautionary or corrective medical advice

Engineering Contradiction:
Improveutility of diagnostic resultsVSAvoidtime for preventive intervention
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent performs risk assessment in the first or second trimester, which is preliminary to the late second or third trimester when conventional methods operate. This timing allows sufficient lead time for pregnant subjects to seek and implement precautionary or corrective medical advice, thereby resolving the contradiction between result utility and available intervention time.

Inventive Principle:
Principle #10Preliminary action

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enables early and accurate preterm delivery risk assessment, allowing for timely preventive measures and improving outcomes by identifying risks before they develop into complications.

Implementation Method 1

determining a quantitative abundance of each of a plurality of predetermined microbial marker sequences associated with the biological sample, from the extracted DNA sequences, using a set of probes specific to each of the plurality of predetermined microbial marker sequences associated with the biological sample, through a multiplexed quantitative Polymerase Chain Reaction (qPCR) technique

Methodology Applied
Scientific EffectPolymerase Chain Reaction (qPCR):

Data Source

PatentUS20240360509A1Early risk assessment of preterm delivery in a subject
Publication Date: 2024.10.31 TATA CONSULTANCY SERVICES LTD
  • US20240360509A1 patent drawing
  • US20240360509A1 patent drawing
  • US20240360509A1 patent drawing

AI summary

This disclosure relates more particularly to risk assessment of preterm delivery (PTD) in the subject and designing a personalized recommendation for the same. Conventional techniques for PTD risk assessment are either invasive or minimally invasive and leaves little time for subjects to take precautionary or corrective medical advice or procedures to reduce or obviate the risk. The present disclosure provides the risk assessment of the PTD, by quantifying a microbial abundance in oral or gut microbiome for a pregnant woman, identifying a certain combination of microbial biomarkers using an ensemble of models for accurate risk assessment of the PTD and subsequently suggesting a personalized recommendation for at risk subject. The present assessment technique is completely non-invasive and further helps in characterizing the risk of the PTD.