Multiparametric Protein Panel for Prostate Cancer Diagnosis

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Solution Overview

Problem

Current methods for diagnosing prostate cancer, particularly through PSA measurement, suffer from high false-positive rates, leading to unnecessary biopsies and overtreatment, and lack sensitivity and specificity in identifying the presence of cancer.

Innovation Solution

A method involving the quantitative detection of specific proteins such as thrombospondin 1 (THBS1), cathepsin D (CTSD), olfactomedin 4 (OLFM4), and intercellular adhesion molecule 1 (ICAM1) in combination with free Prostate-Specific Antigen (PSA) ratios, using immunoassays to calculate a combined score for improved diagnostic accuracy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If PSA measurement is used for prostate cancer diagnosis, then early detection capability is improved, but false-positive rate increases leading to unnecessary biopsies

Engineering Contradiction:
Improveearly detection capabilityVSAvoidfalse-positive rate
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The patent combines PSA measurement with multiple additional protein markers (total 5-10 proteins including hK2, PSMA, PAP, and others) to create a multiparametric diagnostic panel. This merging of multiple detection targets improves early detection sensitivity while the combined analysis increases specificity by requiring consistent abnormal patterns across multiple markers, thereby reducing false positives and unnecessary biopsies.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent changes from measuring a single parameter (PSA level) to measuring multiple parameters (PSA plus 5-10 additional protein markers). This parameter expansion allows for more nuanced interpretation where the pattern across multiple markers provides better diagnostic accuracy, reducing both false positives and false negatives compared to PSA alone.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If free to total PSA ratio is used to improve diagnostic accuracy, then cancer detection specificity is improved, but false positives still occur due to non-cancer factors

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidsusceptibility to non-cancer influences
Core Design Contradiction:
Measurement precisionVSAdaptability or versatility

Solution Approach 1:

The patent employs a panel of protein markers that serve multiple diagnostic functions simultaneously. The markers detect various aspects of prostate pathology including cancer, benign prostatic hyperplasia, and prostatitis, allowing the system to differentiate between these conditions. This multi-functionality enables accurate diagnosis even when individual markers are influenced by non-cancer factors.

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

Solution Approach 2:

The patent uses the combined pattern of multiple protein markers as feedback to interpret PSA results. When PSA or free-to-total ratio shows abnormality, the system evaluates additional markers to confirm or refute the finding. This feedback mechanism distinguishes true cancer signals from false positives caused by benign conditions or temporary factors like recent ejaculation.

Inventive Principle:
Principle #23Feedback

3Measurement precision

If multiple protein markers are measured simultaneously, then diagnostic specificity is improved, but test complexity increases

Engineering Contradiction:
Improvediagnostic specificityVSAvoidtest complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent merges multiple protein detection functions into a single integrated diagnostic test. By simultaneously measuring 6-11 protein markers in one assay platform, the system achieves high diagnostic specificity without requiring multiple separate tests. This consolidation reduces operational complexity compared to performing individual tests for each marker.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent employs a universal detection platform that can measure multiple different protein markers using the same basic assay technology and equipment. This multi-functional approach allows the system to achieve high diagnostic specificity through multiple markers while avoiding the complexity of maintaining separate specialized assays for each protein.

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

This approach significantly reduces unnecessary biopsies by 60% while maintaining 90% sensitivity, providing a more accurate diagnosis of prostate cancer with high specificity, thereby improving patient outcomes.

Implementation Method 1

A method involving the quantitative detection of specific proteins such as thrombospondin 1 (THBS1), cathepsin D (CTSD), olfactomedin 4 (OLFM4), and intercellular adhesion molecule 1 (ICAM1) in combination with free Prostate-Specific Antigen (PSA) ratios, using immunoassays to calculate a combined score

Methodology Applied
Scientific EffectImmunoassay:

Data Source

PatentUS11320435B2Method of detecting proteins in human samples and uses of such methods
Publication Date: 2022.05.03 PROTEOMEDIX AG
  • US11320435B2 patent drawing
  • US11320435B2 patent drawing
  • US11320435B2 patent drawing

AI summary

A method for collecting information about the health status of a subject is proposed involving the quantitative detection, in serum, plasma or blood of the subject, of the concentration of THBS1, the proportion of free PSA (% fPSA), preferably including the concentration of at least one protein selected from the group consisting of CTSD, OLFM4, ICAM1.