miRNA Universal Screening Test for Early Pathology Detection

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Solution Overview

Problem

Current screening tests are disease-specific, making them impractical for widespread use and economically unfeasible for rare diseases, as they require high specificity and sensitivity, leading to false positives and increased medical expenses.

Innovation Solution

Development of universal screening tests (USTs) using organ system-, organ-, tissue-, and cell type-enriched miRNAs in bodily fluids, which are minimally invasive, detectable, stable, and specific, allowing for early detection of pathological changes without diagnosing a particular disease, and can differentiate between general pathological processes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If disease-specific screening tests are developed for each pathology, then detection precision is improved, but device complexity and economic feasibility deteriorate

Engineering Contradiction:
Improvedetection precisionVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent applies universality by developing a single miRNA-based screening test platform that can detect multiple organ system pathologies simultaneously. The test uses a common technical approach (miRNA quantification in bodily fluids) to screen for pathologies across different organ systems, eliminating the need for separate disease-specific tests while maintaining detection precision through organ system-specific miRNA biomarkers.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Measurement precision

If disease-specific screening tests are developed for each pathology, then detection precision is improved, but economic feasibility deteriorates

Engineering Contradiction:
Improvedetection precisionVSAvoideconomic feasibility
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

The patent reduces economic burden by creating a universal screening test that replaces numerous disease-specific tests. The single test platform detects multiple organ system pathologies, reducing the need for multiple separate tests and associated costs, while maintaining detection precision through specific miRNA biomarkers for each organ system.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent merges multiple disease-specific screening functions into a single universal test. By combining the detection of various organ system pathologies into one miRNA-based assay, it consolidates resources and reduces the overall cost of screening programs while maintaining the ability to detect specific pathologies with high precision.

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If high specificity is required for screening tests, then false positives are reduced, but the number of required tests increases

Engineering Contradiction:
ImprovespecificityVSAvoidnumber of tests
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent uses organ system-specific miRNA biomarkers that provide high specificity within a single universal test. Each organ system has characteristic miRNA profiles that allow the test to specifically identify pathologies in different organ systems without cross-reactivity, maintaining high specificity while reducing the number of separate tests needed.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Data Source

PatentUS10472681B2miRNA-based universal screening test (UST)
Publication Date: 2019.11.12 DIAMIR LLC
  • US10472681B2 patent drawing
  • US10472681B2 patent drawing
  • US10472681B2 patent drawing

AI summary

Described are methods for early noninvasive or minimally invasive detection of pathological changes in organ systems/organs/tissues/cells by quantifying organ system-/organ-/tissue-/cells type-enriched miRNA in bodily fluids.