Cervical Fluid Biomarker Detection for Early Pregnancy Risk

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Solution Overview

Problem

Current methods for assessing pregnancy risk during early gestation are inaccurate and prone to misdiagnosis due to reliance on blood-based samples, which are influenced by extraneous factors such as blood volume and placental size, leading to inadequate detection of biomarkers.

Innovation Solution

The use of cervical fluid samples, specifically obtained from a pregnant subject, to detect altered levels of biomarkers indicative of pregnancy-associated risks or conditions through single-cell time-of-flight mass spectrometry (CyTOF-MS), focusing on extravillous trophoblast (EVT) cells and biological materials derived from the cervix, with a purity of at least 90% by volume.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If blood-based samples are used for pregnancy risk assessment, then the detection can be performed with established methods, but the accuracy is reduced due to extraneous factors such as blood volume and placental size

Engineering Contradiction:

Improveaccuracy of pregnancy risk assessmentVSAvoidextraneous factors (blood volume, placental size)

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the harmful extraneous factors by switching from blood-based sampling to cervical fluid sampling. Cervical fluid contains cell-free DNA and biomarkers directly from the placenta without being diluted or confounded by maternal blood volume variations or placental size differences, thereby eliminating the harmful factors that reduce diagnostic accuracy

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces cervical fluid as an intermediary medium between the placenta and the diagnostic analysis. This intermediary carries placental biomarkers and cell-free DNA directly from the pregnancy site to the laboratory, bypassing the maternal circulation system that introduces confounding variables

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of manufacture

If blood-based samples are analyzed, then the detection method is well-established, but misdiagnosis occurs due to inaccurate biomarker detection

Engineering Contradiction:

Improveestablished detection methodsVSAvoidbiomarker detection accuracy

Core Design Contradiction:

Ease of manufactureVSMeasurement precision

Solution Approach 1:

The patent changes the fundamental parameter of sample type from blood to cervical fluid. This parameter change transforms the diagnostic approach by using a sample matrix that naturally concentrates placental biomarkers without dilution, thereby improving measurement precision while maintaining compatibility with established detection methodologies

Inventive Principle:

Principle #35Parameter changes

3Measurement precision

If invasive methods are used for accurate diagnosis, then the diagnostic accuracy improves, but the invasiveness and patient discomfort increase

Engineering Contradiction:

Improvediagnostic accuracyVSAvoidminimally invasive procedure

Core Design Contradiction:

Measurement precisionVSEase of operation

Solution Approach 1:

The patent uses cervical fluid as an intermediary that can be obtained through minimally invasive collection methods. The fluid naturally accumulates in the cervix and can be sampled using simple swabs or collection devices, providing high-quality diagnostic material without requiring invasive procedures

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent leverages the natural accumulation of cervical fluid in the cervix during pregnancy. The body itself provides the diagnostic sample through physiological secretions, eliminating the need for invasive extraction procedures while ensuring adequate sample quality for accurate diagnosis

Inventive Principle:

Principle #25Self-service

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

Provides accurate and minimally invasive detection of early gestational complications, such as placental dysfunction, preeclampsia, and preterm birth, by identifying elevated or decreased levels of biomarkers in cervical fluid samples within 24 hours, with a high degree of precision.

Implementation Method 1

performing single-cell time-of-flight mass spectrometry (CyTOF-MS) on the biological sample to generate an output

Methodology Applied

Scientific EffectTime-of-flight mass spectrometry: Time of Flight

Data Source

PatentUS20250334591A1Identification of cervical biomarkers

Publication Date: 2025.10.30 AKNA HEALTH INC

AI summary

Provided herein are methods and kits for identifying a pregnancy-associated risk or condition in a subject. In embodiments, the methods include detecting levels of at least one biomarker in a substantially cell-free cervical fluid sample obtained from the subject. In embodiments, the methods include detecting levels of biomarkers in a cervical fluid sample including extravillous trophoblasts (EVT) obtained from the subject.