miR-137 and COX6A2 Biomarker Assay for Psychosis Classification
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Solution Overview
Problem
Current diagnostic and prognostic methods for schizophrenia lack objective laboratory-based tests and biomarkers, relying heavily on subjective clinical criteria, making it difficult to accurately classify high-risk psychotic disorder subjects.
Innovation Solution
A method involving the determination of miR-137 and COX6A2 expression levels in biological samples, particularly peripheral blood, to classify subjects as high-risk psychotic disorder subjects, leveraging their significant correlation in early psychosis patients.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If clinical criteria and psychological evaluation are used for diagnosis, then diagnostic coverage is maintained, but measurement precision and objectivity deteriorate
Solution Approach 1:
The patent replaces subjective clinical evaluation methods with objective molecular biology detection methods. Specifically, it uses quantitative real-time PCR to detect miR-137 expression levels and Western blotting to detect COX6A2 protein levels, substituting the 'mechanical' clinical assessment process with molecular detection systems that provide quantifiable, objective data for diagnosis and risk stratification.
2Reliability
If comprehensive medical exam and psychological evaluation are performed, then reliability of diagnosis is improved, but loss of time and productivity worsen
Solution Approach 1:
The patent extracts the essential diagnostic information from complex clinical evaluations by focusing on specific molecular biomarkers (miR-137 and COX6A2). Instead of performing comprehensive psychological evaluations and medical exams, the method extracts and measures only the critical molecular indicators that correlate with psychosis risk, significantly reducing diagnostic time while maintaining reliability.
Solution Approach 2:
The patent enables preliminary risk stratification by detecting molecular biomarkers before full-blown psychosis develops. By measuring miR-137 and COX6A2 levels in the clinical high-risk period, the method allows early identification and intervention before the disease fully manifests, reducing the time needed for definitive diagnosis and treatment planning.
3Measurement precision
If subjective clinical criteria are used for classification, then ease of operation is maintained, but measurement precision and classification accuracy deteriorate
Solution Approach 1:
The patent changes the diagnostic parameters from subjective clinical symptoms to objective molecular biology parameters. By measuring the expression level of miR-137 and the protein level of COX6A2, the method transforms the diagnostic process into quantifiable molecular measurements, providing precise classification criteria based on molecular profiles rather than subjective symptom assessment.
Data Source
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AI summary
The present invention relates to the filed of diagnostic and/or prognostic and/or subject stratification biomarker assays for the prognosis and/or diagnosis and/or therapy of high risk early psychosis subjects, wherein psychotic disorder may include schizophrenia, bipolar disorder (manic depression), epilepsy, mood disorder, age-related disorders, or cognitive impairment, or another psychotic disorder. The expression markers used are miR-137 and COX6A2. The present invention also relates to the use of mitochondria-targeted antioxidant in the treatment of subjects classified as high-risk early psychosis subjects and to a kit comprising means for determining said markers.