CpG Methylation Biomarkers for Prostate Cancer Recurrence Detection

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Solution Overview

Problem

Current diagnostic tools for prostate cancer lack sensitivity and specificity, leading to over-diagnosis and over-treatment, and there is a need for prognostic markers to distinguish aggressive tumors, as existing methods like PSA testing and digital rectal exams are imperfect and invasive.

Innovation Solution

Identification of specific genomic DNA methylation biomarkers, particularly at CpG loci, which can differentiate between patients who will experience biochemical recurrence of prostate cancer, allowing for more precise diagnosis and prognosis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If PSA testing and digital rectal exams are used for prostate cancer detection, then screening coverage is achieved, but sensitivity and specificity are insufficient leading to over-diagnosis and over-treatment

Engineering Contradiction:
Improvediagnostic accuracyVSAvoiddiagnostic method complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent changes the diagnostic parameter from general PSA levels to specific methylation patterns at CpG loci. By analyzing the methylation status of multiple CpG sites simultaneously, the method achieves higher diagnostic accuracy and ability to distinguish aggressive from non-aggressive tumors, resolving the contradiction between reliability and the complexity of requiring multiple measurements.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If invasive biopsy is performed to confirm prostate cancer diagnosis, then diagnostic precision is improved, but patient discomfort and procedural risk increase

Engineering Contradiction:
Improvecancer detection precisionVSAvoidbiopsy invasiveness
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent uses methylation biomarkers as an intermediary between non-invasive sampling and definitive cancer diagnosis. By detecting methylation patterns in easily obtainable samples and using them to predict aggressive tumor behavior, the method reduces the need for invasive biopsies while maintaining diagnostic precision for identifying patients who truly need further intervention.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If all prostate cancer cases are treated aggressively, then lethal cases are addressed, but unnecessary treatments are administered to slow-growing tumors

Engineering Contradiction:
Improveprognostic accuracyVSAvoidover-treatment harm
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent applies local quality by identifying specific methylation patterns that are characteristic of aggressive tumor behavior versus slow-growing tumors. Rather than treating all prostate cancers uniformly, the method enables differentiation at the molecular level, allowing clinicians to tailor treatment intensity to the specific biological characteristics of each tumor, thereby avoiding over-treatment of indolent cases while ensuring aggressive cases receive appropriate care.

Inventive Principle:
Principle #3Local quality

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

The use of CpG methylation biomarkers provides a statistically significant improvement in predicting biochemical recurrence and distinguishing prostate tumor tissue from benign tissue, reducing unnecessary treatments and improving patient outcomes by identifying aggressive tumors more accurately.

Implementation Method 1

differential methylation level of CpG loci that are determinative of a biochemical reoccurrence of prostate cancer

Methodology Applied
Scientific EffectDNA methylation:

Data Source

PatentUS11566291B2Differential methylation level of CpG loci that are determinative of a biochemical reoccurrence of prostate cancer
Publication Date: 2023.01.31 HUDSONALPHA INST FOR BIOTECH
  • US11566291B2 patent drawing
  • US11566291B2 patent drawing
  • US11566291B2 patent drawing

AI summary

The present disclosure provides for and relates to the identification of novel biomarkers for diagnosis and prognosis of prostate cancer or the biochemical reoccurrence of prostate cancer. The biomarkers of the invention show altered methylation levels of certain CpG loci relative to normal prostate tissue, as set forth.