Microparticle Protein Biomarkers for Preterm Birth Detection

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Solution Overview

Problem

Current methods lack specificity and sensitivity in diagnosing preterm birth risk in pregnant women, leading to inadequate proactive management and increased morbidity and mortality among premature infants.

Innovation Solution

The use of biomarkers such as A1BG, AFM, AHSG, ALB, and others detected in microparticle-enriched fractions from pregnant subjects to assess the risk of preterm birth, with therapeutic agents like progesterone administered to decrease the risk when elevated levels are detected.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If current diagnostic methods are used for preterm birth risk assessment, then the process is simple and quick, but the specificity and sensitivity are insufficient leading to inaccurate risk identification

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidmethod complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The diagnostic approach is segmented into multiple components: (1) isolation of microparticles from maternal serum, (2) extraction of proteins from microparticles, and (3) detection of specific protein markers. This segmentation allows each step to be optimized independently, improving overall diagnostic accuracy while managing complexity through systematic breakdown of the diagnostic process

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Microparticles serve as an intermediary carrier between the maternal system and the detectable biomarkers. By isolating and analyzing proteins associated with these microparticles, the method achieves higher specificity and sensitivity compared to direct serum analysis, as the microparticles concentrate and protect the biomarkers of interest

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If biomarker analysis is performed on total serum, then the detection limit is high, but the signal-to-noise ratio is low due to classic signal to noise issues

Engineering Contradiction:
Improvedetection sensitivityVSAvoidbiomarker concentration
Core Design Contradiction:
Measurement precisionVSQuantity of substance

Solution Approach 1:

The method extracts proteins specifically from microparticles isolated from maternal serum, rather than analyzing total serum proteins. This extraction process concentrates the relevant biomarkers (removing them from the dilute serum environment) while eliminating the overwhelming background of unrelated serum proteins, thereby significantly improving the signal-to-noise ratio and detection sensitivity

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The method changes the physical and chemical parameters of the sample by isolating microparticles based on their size, density, and surface properties. This parameter-based separation enriches the concentration of microparticle-associated proteins while depleting bulk serum proteins, effectively increasing the biomarker concentration and improving detection limits

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS11835530B2Detection of microparticle-associated proteins associated with spontaneous preterm birth
Publication Date: 2023.12.05 NX PRENATAL INC
  • US11835530B2 patent drawing
  • US11835530B2 patent drawing

AI summary

The present disclosure relates to biomarkers of preterm birth, biomarkers of term birth, and methods of use thereof. In particular, the present disclosure provides methods of determining whether a pregnant woman is at an increased risk for premature delivery. The present disclosure further provides methods for decreasing a pregnant woman's risk for premature delivery.