Noninvasive Molecular Clock for Gestational Age and Preterm Delivery

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Solution Overview

Problem

Current methods for determining gestational age and predicting preterm delivery are imprecise, leading to unnecessary medical interventions and high healthcare costs, as they rely on ultrasound imaging and the patient's last menstruation period, which are not effective for predicting preterm delivery.

Innovation Solution

Generating an expression profile using cell-free RNA or protein from a maternal sample and comparing it with reference profiles to estimate gestational age and assess the risk of preterm delivery by analyzing placental gene expression.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If ultrasound imaging or last menstruation period estimation is used to determine gestational age, then the method is simple and widely available, but the precision and ability to predict preterm delivery are insufficient

Engineering Contradiction:

Improvegestational age estimation precisionVSAvoidtesting method complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces mechanical ultrasound imaging with a molecular biology-based testing system that measures mRNA expression levels of specific genes in maternal blood samples. This substitution enables precise gestational age determination through biochemical measurements rather than mechanical imaging, achieving the goal of improving measurement precision while maintaining practical applicability through blood sample analysis.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent utilizes changes in mRNA expression levels of specific genes (such as PGAM1, GAPDH, and other placental-specific genes) as a function of gestational age. By monitoring the dynamic changes in these molecular parameters over time, the system can precisely determine gestational age and predict preterm delivery, transforming static anatomical measurements into dynamic molecular biomarkers.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If current methods are used to monitor fetal development, then healthcare costs are high due to unnecessary interventions, but the ability to predict preterm delivery is limited

Engineering Contradiction:

Improvepreterm delivery prediction accuracyVSAvoidhealthcare resource expenditure

Core Design Contradiction:

ReliabilityVSLoss of energy

Solution Approach 1:

The patent enables preliminary identification of women at risk for preterm delivery by measuring gene expression profiles in maternal blood samples during routine prenatal visits. By detecting molecular biomarkers before clinical symptoms manifest, the system allows for early intervention and prophylactic treatment, preventing preterm delivery and reducing the need for expensive neonatal intensive care resources.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent establishes a feedback mechanism where gene expression levels are continuously monitored throughout pregnancy, providing real-time information about fetal development status and preterm delivery risk. This feedback loop enables dynamic adjustment of prenatal care strategies, allowing clinicians to intervene only when molecular biomarkers indicate actual risk, thereby optimizing healthcare resource allocation.

Inventive Principle:

Principle #23Feedback

Data Source

PatentUS12444478B2Noninvasive molecular clock for fetal development predicts gestational age and preterm delivery

Publication Date: 2025.10.14 CZ BIOHUB SF LLC

AI summary

The invention is directed to methods of identifying woman is risk for preterm delivery. In some aspects, the methods include quantitating one or more placental or fetal-tissue specific genes in a biological sample from the woman.