Biological Status Profiling With Gender-Matched Analyte References
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Solution Overview
Problem
Current healthcare systems face challenges in accurately classifying an individual's biological status due to variability in test reagents, protocols, and inter-individual differences, leading to inconsistent and potentially inaccurate diagnostic results, especially in preventative healthcare models that lack consideration for environmental stressors and individual biological variations.
Innovation Solution
A method involving obtaining biological samples from individuals, analyzing endogenous and exogenous analytes, and comparing them to reference data from healthy individuals of the same gender and location to classify health status accurately, using consistent analytical processes and equipment to account for individual variations and environmental factors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If biological samples are analyzed using different test reagents, methods, and protocols from different providers, then more testing options and accessibility are available, but significant variability exists between and within test providers leading to inconsistent clinical interpretation
Solution Approach 1:
The patent changes the reference parameter from population-based norms to individual-based baselines. By establishing personalized reference ranges through longitudinal sampling of each individual, the system maintains measurement precision across different testing providers while allowing versatility in testing options. The key parameter change is shifting from comparing an individual to a population average to comparing an individual's current state to their own historical baseline.
Solution Approach 2:
The patent segments the reference data into two distinct components: (1) population-based reference ranges for initial screening, and (2) individual-specific baselines developed through longitudinal sampling. This segmentation allows the system to leverage both population norms and personal history, resolving the contradiction by applying different reference types at different stages of the diagnostic process.
2Ease of manufacture
If population norm-based reference data is used for comparing test results, then standardization across different providers is simplified, but inter-individual biological variation adds uncertainty and reduces accuracy
Solution Approach 1:
The patent applies preliminary action by collecting multiple baseline samples from each individual before formal diagnostic testing begins. This preliminary sampling phase establishes personalized reference ranges that account for each individual's unique biological variation, thereby improving diagnostic accuracy without compromising standardization. The baseline collection is performed in advance using standardized protocols.
Solution Approach 2:
The patent transitions from static population-based reference ranges to dynamic individual-specific baselines that update over time. The reference data becomes dynamic as new baseline samples are collected and incorporated, allowing the system to adapt to each individual's changing biological state while maintaining rigorous standardization through consistent sampling protocols.
3Ease of manufacture
If traditional reactive healthcare models are used where sick individuals visit clinics for treatment, then existing healthcare infrastructure is utilized, but the model is sub-optimal and does not support preventative healthcare effectively
Solution Approach 1:
The patent implements preliminary action by establishing individual baseline health profiles through longitudinal sampling before disease manifests. This allows for early detection of deviations from normal patterns, enabling preventative intervention rather than reactive treatment. The system performs health assessment in advance, identifying trends and anomalies before they develop into clinical conditions.
Solution Approach 2:
The patent implements continuous feedback loops where individual baseline data is constantly updated and compared against current measurements. This feedback mechanism enables real-time monitoring of health status and automatic alerting when deviations occur, transforming the static reactive model into a dynamic preventative system that provides continuous health management.
4Device complexity
If environmental stressors and toxicants are not considered in healthcare models, then the model remains simple and manageable, but a fundamental disease driver is overlooked reducing preventative capability
Solution Approach 1:
The patent applies universality by designing a multi-functional baseline sampling system that simultaneously captures multiple types of information: physiological markers, environmental exposures, lifestyle factors, and genetic predispositions. This comprehensive baseline serves multiple purposes including disease risk assessment, environmental toxicant monitoring, and personalized reference range establishment, all within a single integrated framework.
Data Source
AI summary
There is provided a method of classifying a biological status of an individual. The method comprising: obtaining a biological sample from a patient; obtaining health-related information from the patient, said information including patient gender; analysing the sample to identify a quantity of each of 2 or more endogenous analytes in the sample; comparing the analyte quantities to reference data from healthy individuals to classify the patient as healthy, pre-diseased, at risk of disease or diseased for at least one health-related condition. The reference data includes data derived from a group of biological samples of individuals having the same gender as the patient and not having a need for medical treatment for a disease or illness, each biological sample of the group of biological samples having been analysed by the same process as used to analyse the patient sample, the process being monitored to maintain a predetermined level of consistency.