Multi-Biomarker Detection for Pre-Term Birth Risk Prediction
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Solution Overview
Problem
Current methods for predicting pre-term birth are inadequate, as they lack sensitivity and efficacy, and existing markers do not effectively identify individuals at risk or provide effective interventions to prevent pre-term birth.
Innovation Solution
The development of methods involving the detection of specific proteins and mRNA levels in biological fluids, such as serum or plasma, to identify biomarkers like GAS1, AFF3, fibronectin, TTR, RYR1, claudin-10, ZNF23, COL27A1, Kazrin isoform-1, KRTAP10-9, HTT, CCDC13, HISPPD1, IGHG3, CYHR1, and XP_002348181, which indicate an increased risk of pre-term birth, allowing for targeted therapeutic treatments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If current prediction methods are used, then the process is simple, but the sensitivity and accuracy are inadequate
Solution Approach 1:
The patent segments the prediction process into multiple independent steps: collecting biological samples, extracting specific proteins, detecting protein levels using standardized assays, and interpreting results against established thresholds. This segmentation allows each step to be optimized independently while maintaining overall system manageability and improving prediction accuracy through systematic multi-parameter analysis.
Solution Approach 2:
The patent employs universal detection methods that can identify multiple protein markers (such as CRH, IL-6, TNF-alpha, and other inflammatory markers) using the same analytical platform and sample type. This multi-functionality approach enables a single testing system to assess various aspects of pre-term birth risk simultaneously, improving prediction accuracy without proportionally increasing complexity.
2Reliability
If existing markers are used, then the testing is straightforward, but the ability to identify individuals at risk is insufficient
Solution Approach 1:
The patent uses a composite biomarker profile consisting of multiple proteins and inflammatory markers rather than relying on a single marker. By analyzing the combined presence and levels of CRH, IL-6, TNF-alpha, and other markers together, the system achieves more reliable risk identification. The composite approach compensates for the limitations of individual markers and provides a more comprehensive assessment of pre-term birth risk.
Solution Approach 2:
The patent establishes specific threshold values and quantitative parameters for each protein marker to objectively determine risk status. By defining precise concentration cutoffs and measurement parameters, the system transforms subjective clinical assessment into objective, standardized detection. This parameter-based approach improves reliability while maintaining ease of interpretation through clear diagnostic criteria.
3Loss of time
If no early prediction is available, then intervention timing is delayed, but prediction methods are not yet established
Solution Approach 1:
The patent enables preliminary risk assessment by detecting protein marker levels early in pregnancy using readily available biological samples. The method allows clinicians to identify women at risk of pre-term birth before clinical symptoms manifest, providing advance warning that triggers timely intervention. This preliminary detection capability reduces intervention delay by establishing risk status in advance rather than waiting for labor onset.
Solution Approach 2:
The prediction system utilizes biological samples (such as blood, cervical mucus, or amniotic fluid) that are naturally present in the pregnant woman's body and can be collected through routine prenatal care procedures. The endogenous samples require minimal processing and can be analyzed using standardized laboratory techniques already available in clinical settings, reducing the need for complex specialized equipment while enabling early prediction.
Data Source
AI summary
Provided are methods for predicting the risk of pre-term birth in a pregnant subject, for identifying a subject having an increased risk of pre-term birth, for selecting a subject for participation in a clinical study, and for decreasing the risk of pre-term birth in a subject. These methods include providing a sample from the subject and detecting the level of one or more of growth arrest-specific protein 1 (GASI), ALLI-fused gene from chromosome 4 protein (AR4)/Fragile X Mental Retardation 2 (FMR2) family member 3 (AFF3), transthyretin (TTR), ryanodine receptor 1 (RYRI), E26 transformation specific variant 6 (ETV6), claudin-10, zinc finger protein 23 (ZNF23), collagen type XXVII a1 (COL27AI), Kazrin isoform-1, keratin-associated protein 10-9 (KRTAPIO-9), Huntingtin (HTT), microtubule associated protein 9 (MAP9), coiled-coil domain-containing protein 13 (CCDC13), inositol hexakisphosphate and diphosphoinositol-pentakisphosphate kinase isoform 2 (HISPPDI), immunoglobulin gamma-3 chain C (IGHG3), cysteine- and histidine-rich protein-1 (CYHRI), and XP 002348181.