NOCIVA Splice Variant Biomarker for AML Prognosis

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Solution Overview

Problem

Current diagnostic methods for acute myeloid leukemia (AML) lack sensitivity for stratifying patients according to prognosis, leading to inadequate treatment strategies, as existing markers do not effectively differentiate between favorable and poor prognosis patients, and there is a need for new molecular markers for monitoring minimal residual disease.

Innovation Solution

Identification of a novel splice variant of CIP2A, named NOCIVA, which serves as a biomarker for cancer diagnosis and prognosis, including AML, through specific antibodies, probes, and primers that target NOCIVA, allowing for its detection and quantification in patient samples.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If current diagnostic methods and existing markers are used for AML patient stratification, then the diagnostic process is simple and familiar, but the sensitivity and accuracy for differentiating prognosis groups is insufficient

Engineering Contradiction:
Improveprognosis differentiation accuracyVSAvoiddiagnostic method complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent segments the diagnostic approach by introducing a novel splice variant marker (NOCIVA) that specifically targets a distinct molecular subgroup of AML patients. This segmentation enables differentiation between favorable and poor prognosis groups that were previously indistinguishable using conventional markers, thereby improving measurement precision without requiring complete overhaul of existing diagnostic infrastructure

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent changes the molecular parameter being measured by shifting from conventional markers to the novel NOCIVA splice variant. This parameter change reveals previously hidden prognostic information, allowing accurate stratification of patients into distinct prognosis groups. The change is implemented through targeted molecular testing that can be integrated into existing diagnostic workflows

Inventive Principle:
Principle #35Parameter changes

2Reliability

If new molecular markers like NOCIVA are introduced for AML prognosis, then the accuracy of patient stratification improves, but the complexity of diagnostic procedures increases

Engineering Contradiction:
Improveprognosis prediction reliabilityVSAvoiddiagnostic system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent performs preliminary action by identifying and validating the NOCIVA splice variant as a reliable prognostic marker before clinical implementation. Extensive validation has been completed to establish its reliability in predicting poor prognosis, ensuring that when the test is deployed, it immediately provides high-confidence results without requiring complex interpretation or additional validation steps in clinical settings

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent introduces NOCIVA as an intermediary molecular marker that bridges the gap between conventional diagnostic markers and the actual prognostic outcome. This intermediary provides specific molecular information about PP2A pathway dysfunction that directly correlates with poor prognosis, serving as a reliable mediator that translates molecular biology into clinically actionable prognostic information

Inventive Principle:
Principle #24Intermediary (Mediator)

3Adaptability or versatility

If conventional PCR tests for fusion genes and mutations are used, then the testing procedure is standardized and widely available, but only half of AML patients have relevant molecular genetic tests available

Engineering Contradiction:
Improvemarker applicability across patient populationsVSAvoidnumber of available molecular tests
Core Design Contradiction:
Adaptability or versatilityVSQuantity of substance

Solution Approach 1:

The patent achieves universality by developing a diagnostic approach based on NOCIVA splice variant detection that is applicable across all AML patient populations, regardless of their specific fusion gene or mutation status. Unlike conventional tests that target specific genetic abnormalities present in only subsets of patients, the NOCIVA marker provides relevant prognostic information for all AML cases, making the diagnostic system universally applicable

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

Solution Approach 2:

The patent employs partial action by focusing on detecting the specific NOCIVA splice variant rather than attempting to identify all possible molecular abnormalities in AML. This targeted approach provides sufficient prognostic information for risk stratification without requiring comprehensive testing of all potential molecular alterations, thereby increasing marker applicability while maintaining diagnostic efficiency

Inventive Principle:
Principle #16Partial or excessive action

Data Source

PatentUS11680092B2CIP2A variant and uses thereof
Publication Date: 2023.06.20 UNIVERSITY OF TURKU
  • US11680092B2 patent drawing
  • US11680092B2 patent drawing
  • US11680092B2 patent drawing

AI summary

The present invention relates to a novel cancer-associated biomarker and different applications and uses thereof. More specifically, the invention relates to a novel splice variant of CIP2A denoted as NOCIVA, as well as binding bodies such as probes, amplification primers, and antibodies specific for the same. Also provided are various methods for detecting and prognosing cancer on the basis of said splice variant, and a kit for use in said methods.