Multiplex Cellular Reference Materials for Multi-Biomarker Validation
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Solution Overview
Problem
Conventional reference materials are limited in analyzing samples with unknown features, as they require a library of controls for each biomarker, complicating the analysis, especially in cancer assays that screen for multiple biomarkers.
Innovation Solution
A nucleic acid comprising a plurality of nucleotide sequences, each corresponding to a genotype associated with a disease, is used to create a biological reference material, which can be transfected into cells, fixed, and embedded in paraffin for use as a multiplexed control, simplifying quantification and detection of multiple genotypes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a library of controls is used to analyze samples with unknown features, then the analysis can cover multiple biomarkers, but the complexity of the analysis increases
Solution Approach 1:
The patent combines multiple genotype controls into a single multiplexed reference material that contains several different genotypes simultaneously. This allows the reference material to serve multiple functions - it can be used to validate detection of multiple different biomarkers or mutations in a single assay run, thereby reducing the complexity of using separate control libraries while maintaining versatility
Solution Approach 2:
The multiplexed reference material is designed to perform multiple functions: it can detect and validate various genotypes, serve as a positive control for different biomarkers, and enable quantification of multiple targets simultaneously. This universal reference material replaces the need for multiple specialized controls, simplifying the overall analysis process while maintaining the ability to screen for multiple biomarkers
2Reliability
If a library of single-mutant controls is used, then each biomarker can be validated, but the cost increases
Solution Approach 1:
The patent merges multiple single-mutant controls into one multiplexed reference material containing several genotypes. This consolidation reduces the total quantity of reference materials needed while maintaining the ability to validate each biomarker, thereby reducing costs without compromising reliability
Solution Approach 2:
The multiplexed reference material serves as a universal control that can validate multiple biomarkers simultaneously. Instead of requiring separate single-mutant controls for each biomarker, this single material provides comprehensive validation capability, reducing the overall cost of biomarker validation while maintaining reliability
3Measurement precision
If multiple reference materials are used for different genotypes, then each genotype can be detected accurately, but the quantification process becomes more complex
Solution Approach 1:
The patent combines multiple genotype references into a single multiplexed reference material, allowing quantification of multiple genotypes from one standardized source. This simplifies the quantification process by eliminating the need to prepare and manage multiple separate reference materials, while maintaining detection accuracy through the inclusion of multiple distinct genotypes in the same material
Data Source
AI summary
Disclosed are nucleic acids, comprising a plurality of nucleotide sequences, and each nucleotide sequence of the plurality comprises a genotype that is associated with a disease or condition. For example, each nucleotide sequence of the plurality may be a human nucleotide sequence, and each genotype may be a somatic mutation that is associated with a neoplasm or a heart condition (e.g., cardiomyopathy). Also disclosed are cells comprising the nucleic acid, e.g., wherein the cell is a human cell. A related biological reference material comprises a plurality of cells comprising the nucleic acid, and a plurality of cells that do not comprise the nucleic acid (e.g., untransfected cells). The cells of the reference material may be fixed (e.g., with formalin) or embedded in paraffin.