Gene Expression Panel for Cystic Fibrosis Exacerbation Risk Stratification

The patent segments the complex task of predicting pulmonary exacerbation risk by dividing it into multiple independent gene expression measurements. Instead of using a single complex marker, the invention measures expression levels of multiple specific genes (including TLR2, ADAM2, PLXND1, CD163, CD36, CD64, CSPG2, IL32, HPSE, and HCA112) separately, then combines these measurements to achieve high prediction accuracy. This segmentation allows each gene to be measured independently with high precision while maintaining overall method manageability.

The patent changes the measurement parameters from traditional clinical assessments to molecular gene expression levels. By measuring the expression levels of specific genes rather than relying on clinical symptoms or simple biomarkers, the invention achieves superior measurement precision. The method compares detected expression levels against established thresholds or reference ranges to categorize subjects into risk groups, transforming the categorization process from subjective clinical judgment to objective molecular measurement.

The patent replaces complex mechanical and clinical assessment procedures with molecular biology-based detection methods. Instead of relying on physical examinations, symptom assessment, or complex imaging studies, the invention uses gene expression detection (such as qRT-PCR or other molecular assays) to directly measure biological markers. This substitution provides highly reliable and sensitive risk prediction, as gene expression levels directly reflect the underlying biological processes driving pulmonary exacerbation risk.

The patent performs preliminary detection of gene expression levels before clinical exacerbation events occur. By measuring the expression levels of risk-associated genes in advance (during stable periods or at early signs of deterioration), the method enables early identification of high-risk subjects. This preliminary action allows for proactive intervention before full-blown exacerbation develops, improving both reliability and enabling simpler operational protocols since samples can be collected during routine monitoring rather than during acute episodes.

The patent merges the measurement of multiple gene expression markers into a single integrated detection workflow. Rather than measuring each gene separately in sequential steps that would consume excessive time, the invention uses combined molecular assays (such as multiplex qRT-PCR or gene expression panels) that can detect multiple target genes simultaneously from a single biological sample. This merging approach maintains high measurement precision through multi-marker assessment while significantly reducing the time and resources required compared to sequential individual measurements.

The patent employs a universal detection platform that can measure multiple gene expression markers using a single methodology and sample type. The same molecular assay platform (e.g., quantitative reverse transcription PCR) is used to detect expression levels of all target genes (TLR2, ADAM2, PLXND1, CD163, CD36, CD64, CSPG2, IL32, HPSE, HCA112), eliminating the need for different specialized tests for each marker. This multi-functionality approach achieves precise risk stratification through comprehensive gene panel assessment while streamlining the detection process to minimize time loss and resource consumption.