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
Engineering 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
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.
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
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.
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
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.
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
Data Source
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.


