Circulating RNA Biomarker Panel for Early Preeclampsia Risk
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Solution Overview
Problem
Current methods lack a non-invasive biomarker for accurately predicting preeclampsia across various stages of pregnancy, and existing biomarkers are limited in their predictive capability and applicability.
Innovation Solution
A biomarker combination comprising specific RNA molecular markers, including ALB, FGA, MIR27A, IGFBP5, MIR376C, MIR215, SERPINA1, and MIR106A, along with optional additional markers, is used to construct a prediction model utilizing machine learning algorithms for early and middle-stage pregnancy risk assessment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If maternal risk factors are used for screening, then the screening process is simple, but the prediction accuracy is insufficient due to heterogeneity and complexity of preeclampsia
Solution Approach 1:
The patent combines multiple circulating RNA molecules (including miRNAs, mRNAs, and lncRNAs) into a composite biomarker panel to predict preeclampsia risk. This merging of multiple molecular markers overcomes the insufficiency of single risk factor screening while maintaining a feasible screening approach through blood sample analysis.
Solution Approach 2:
The invention uses a composite biomarker system comprising multiple types of RNA molecules (miRNA, mRNA, lncRNA) that together provide comprehensive prediction capability. This composite approach captures the heterogeneity and complexity of preeclampsia pathogenesis better than single-marker systems.
2Loss of information
If invasive placental tissue sampling is performed to detect functional abnormalities, then diagnostic information can be obtained, but security and safety are compromised for pregnant women and fetuses
Solution Approach 1:
The patent uses circulating RNA molecules in maternal blood as intermediary markers that reflect placental trophoblast cell function without requiring direct placental sampling. These RNA molecules serve as safe mediators that carry diagnostic information about placental health from the placenta to the maternal circulation where they can be non-invasively detected.
Solution Approach 2:
The invention detects copies of placental-derived RNA molecules in maternal blood that replicate the functional information of placental tissue. These circulating RNA copies provide a non-invasive window into placental health, eliminating the need for dangerous invasive sampling while preserving diagnostic capability.
3Loss of time
If existing biomarkers like sFlt-1/PIGF ratio are used, then short-term risk prediction is possible, but long-term and comprehensive prediction capability is limited
Solution Approach 1:
The patent develops a universal biomarker system based on multiple circulating RNA molecules that can predict preeclampsia risk across different time points and pregnancy stages. This multi-functional panel adapts to various clinical scenarios including early pregnancy screening, mid-pregnancy assessment, and monitoring of different preeclampsia subtypes, overcoming the limited scope of existing single-ratio biomarkers.
Data Source
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AI summary
Provided are a biomarker for predicting a preeclampsia risk, use thereof, and a method for detecting whether a subject has a preeclampsia risk. The method predicts the preeclampsia risk in all pregnant women in the early and middle stages of pregnancy, without distinguishing the population with a high preeclampsia risk. The method can predict the risk before symptoms occur. A variety of free RNAs in the blood are associated with preeclampsia, and by establishing a preeclampsia prediction model with samples from at least 300 cases using the biomarker, the present disclosure can improve the specificity of the preeclampsia prediction model during the pregnancy to 85% or higher.