Cell-Free Nucleic Acid Biomarker Panels for Preterm Birth Risk

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Solution Overview

Problem

Current methods fail to effectively identify women at risk of preterm birth and understand the mechanisms leading to it, resulting in high preterm birth rates and associated health complications.

Innovation Solution

The use of specific nucleic acid biomarkers, including miRNA-let-7 g, PSME2, APOA1, NAMPT, and other microRNAs, for detecting preterm birth risk through analyzing transcriptomes and hybridizing with complementary nucleic acids, combined with normalization sequences like PPIA and snRNA:U6 for accurate sample comparison.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current detection methods are used, then the process is simple, but the ability to identify women at risk of preterm birth is insufficient

Engineering Contradiction:
Improvepreterm birth risk identification accuracyVSAvoiddetection method complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent segments the detection process into multiple independent components: selecting specific microRNA biomarkers (miR-155, miR-142-5p, miR-146a, miR-125b, miR-106b), choosing reference genes for normalization (PPIA, snRNA:U6), and using quantitative PCR methods. This segmentation allows each component to be optimized independently while maintaining overall system reliability for identifying preterm birth risk.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent applies parameter changes by measuring specific biochemical parameters (microRNA expression levels) that differ between preterm and term birth conditions. By quantifying the expression levels of selected microRNAs and comparing them against established thresholds, the method achieves reliable risk identification through measurable parameter variations rather than complex procedural changes.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If normalization sequences are used, then the measurement precision is improved, but the analysis process becomes more complex

Engineering Contradiction:
Improvetranscriptome analysis precisionVSAvoidnormalization process complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent introduces normalization sequences (PPIA, snRNA:U6) as intermediary elements that mediate between the raw microRNA expression data and the final risk assessment. These reference genes serve as stable baseline measurements that correct for technical variations in sample preparation and processing, thereby improving measurement precision without requiring complex computational adjustments.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If multiple biomarkers are analyzed, then the detection accuracy is improved, but the time required for analysis increases

Engineering Contradiction:
Improvepreterm birth risk detection accuracyVSAvoidtranscriptome analysis time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent applies preliminary action by pre-selecting a specific panel of microRNA biomarkers (miR-155, miR-142-5p, miR-146a, miR-125b, miR-106b) and reference genes (PPIA, snRNA:U6) based on prior research establishing their diagnostic value. This pre-selection allows clinicians to directly analyze only the most relevant markers using standardized protocols, achieving high detection accuracy while minimizing analysis time compared to comprehensive transcriptome sequencing.

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 detection of preterm birth susceptibility, allowing for timely interventions and reducing the incidence of preterm births and associated health issues.

Implementation Method 1

the analyzing includes hybridizing each nucleic acid biomarker in the nucleic acid sample with a complementary nucleic acid configured as a primer or a probe, the method comprising detecting the hybridizing

Methodology Applied
Scientific EffectHybridization:

Data Source

PatentUS20250270647A1Combinations of cell free nucleic acids
Publication Date: 2025.08.28 ROSETTA SIGNALING LAB LLC
  • US20250270647A1 patent drawing
  • US20250270647A1 patent drawing
  • US20250270647A1 patent drawing

AI summary

A method of detecting a combination of nucleic acid biomarkers in a human subject can include: obtaining a nucleic acid sample from the human subject; selecting the combination of nucleic acid biomarkers; analyzing a transcriptome of the human subject for the combination of nucleic acid biomarkers in the nucleic acid sample from the human subject; detecting in the nucleic acid sample the presence of the combination of nucleic acid biomarkers, wherein each nucleic acid biomarker in the combination of nucleic acid biomarkers has a variation from a transcription standard.