Protease Reporter Probes for Ex Vivo Disease Classification

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Solution Overview

Problem

Current methods for detecting and monitoring diseases such as Non-alcoholic steatohepatitis (NASH) and other conditions like liver diseases, organ transplant rejection, infectious diseases, allergic diseases, autoimmunity, and chronic inflammation lack efficient and accurate techniques for protease activity detection in body fluids.

Innovation Solution

A method involving contacting a body fluid sample with a molecule containing a cleavable linker and a reporter, where the linker is cleaved by an agent from the fluid, releasing the reporter, which is then detected to determine disease conditions, using supervised Machine Learning algorithms for classification.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If current methods are used for detecting diseases, then disease detection can be performed, but the detection precision and accuracy for protease activity in body fluids is insufficient

Engineering Contradiction:
Improveprotease activity detection precisionVSAvoiddisease detection accuracy
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent introduces a probe molecule as an intermediary that mediates between the protease activity in body fluids and the detection system. The probe comprises a substrate portion that specifically binds to the target protease and a reporter portion that generates a detectable signal, enabling precise and reliable measurement of protease activity for disease detection

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent employs probes with different substrate sequences that are selectively cleaved by different proteases, changing the detection parameter to target specific protease activities. This allows differentiation between various disease conditions based on distinct protease profiles, improving both precision and reliability of disease detection

Inventive Principle:
Principle #35Parameter changes

2Reliability

If protease activity detection is implemented, then disease monitoring capability is improved, but the complexity of the detection method increases

Engineering Contradiction:
Improvedisease monitoring capabilityVSAvoiddetection method complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The probe molecules are designed to autonomously interact with target proteases in body fluids without requiring complex sample preparation or purification steps. The probes self-assemble and specifically bind to proteases, generating detectable signals that directly reflect protease activity, thereby simplifying the overall detection workflow while maintaining high reliability

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The detection system uses a family of probes with different substrate sequences that can detect multiple types of proteases using a common detection platform. This multi-functional approach allows comprehensive disease monitoring through a single assay system, reducing complexity compared to multiple separate tests

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

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

Enables precise detection and differentiation of disease conditions by measuring protease activity in body fluids, providing accurate diagnostic and monitoring capabilities for conditions like NASH and liver diseases.

Implementation Method 1

the cleavable linker is cleaved by an agent from the body fluid, releasing the reporter from the molecule

Methodology Applied
Scientific EffectProteolytic hydrolysis: Hydrolysis

Data Source

PatentUS12492422B2Ex vivo protease activity detection for disease detection/diagnostic, staging, monitoring and treatment
Publication Date: 2025.12.09 SUNBIRD BIO INC
  • US12492422B2 patent drawing
  • US12492422B2 patent drawing
  • US12492422B2 patent drawing

AI summary

The present application provides compositions and methods for determining a disease or condition in a subject. The method comprises contacting a body fluid with a molecule comprising a reporter thereof and the reported is cleaved by an agent in the body fluid. Diseases and conditions that can be determined by the method are also described.