Non-invasive gene mutation detection in lung cancer patients
Inventors
Wei, Fang • Wong, David T.W. • SU, WU-CHOU
Assignees
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Publication Number
US-12662695-B2
Publication Date
2026-06-23
Expiration Date
Abstract
A system and method for the detection of saliva biomarkers in bodily fluids is described. In particular, the system is suitable for detecting biomarkers of lung cancer in a subject. The system includes an electrochemical sensor chip having at least one well, wherein the at least one well contains a working electrode coated with a conducting polymer functionalized with at least one capture probe, and at least one labeled detector probe. When the at least one labeled detector probe is mixed with a sample of the subject containing a biomarker of lung cancer and added to the at least one well, an electric current is applied to the sample, such that when at least some of the biomarker binds to the capture probe, a measurable change in electric current in the sample is created that is indicative of lung cancer.
Core Innovation
The invention relates to a non-invasive electrochemical sensor system for detecting lung-cancer biomarkers in a subject using saliva and plasma. A device includes an electrode chip with a working electrode, a counter electrode, and a reference electrode, and the working electrode is coated with a conducting polymer functionalized/embedded with a capture probe capable of binding to a marker associated with lung cancer in the sample.
The system uses a labeled detector probe mixed with the sample, and the mixture is added to the electrode chip. The presence of the lung-cancer marker enables capture/detection by hybridization, and application of a cyclic square-wave electric field across the electrode for each surface reaction enables an electrochemical readout. An amperometric current change is measured and correlated with the presence of the marker associated with lung cancer.
In described embodiments, the lung-cancer marker includes EGFR exon 19 deletion p.E746-A750 and exon 21 L858R, and the capture and detector probes are selected from nucleotide sequence pairings using SEQ ID NO: 1–4. The method generates about 5 cycles to about 10 cycles of the cyclic square wave electric field and measures the current in the electrode chip, wherein the change in current correlates to the marker. Documented performance characteristics include detection in small sample volumes and rapid measurement, including readout within about 10 minutes.
Claims Coverage
The partial claim set includes one independent claim defining the core detection workflow and one detailed independent-claim framework that specifies the cyclic square-wave operation and selected SEQ ID NO probe pairings for capture and detection.
Electrode chip with conducting polymer-embedded capture probe for lung-cancer marker binding
The working electrode is coated with a conducting polymer embedded with a capture probe capable of binding to a marker associated with lung cancer in the sample.
Labeled detector probe mixing and electrochemical hybridization readout
A first portion of the sample is mixed with a solution comprising a labeled detector probe, and a current change is correlated to the presence of the marker associated with lung cancer after capture/detection.
Cyclic square-wave electric field generating 5 to 10 cycles across electrode surfaces
Generating about 5 cycles to about 10 cycles of a cyclic square wave electric field across the electrode for each surface reaction to enable the capture/detection and electrochemical measurement.
Current measurement correlated with marker presence
Measuring the current in the electrode chip wherein a change in current is correlated to the presence of the marker associated with lung cancer in the sample.
Specific capture/detector probe sequence pairings using SEQ ID NO: 1–4
The capture and detection probes are selected from the group consisting of (i) capture probe comprising the nucleotide sequence of SEQ ID NO: 1 and detector probe comprising the nucleotide sequence of SEQ ID NO: 2, and (ii) capture probe comprising the nucleotide sequence of SEQ ID NO: 3 and detector probe comprising the nucleotide sequence of SEQ ID NO: 4.
Across the independent claim, the inventive coverage is directed to using a conducting polymer embedded with a capture probe on a working electrode, mixing the sample with a labeled detector probe, applying a cyclic square-wave electric field in a defined cycle range, and measuring a current change correlated with the presence of a lung-cancer-associated marker, with capture/detector probe selection fixed by SEQ ID NO pairings.
Stated Advantages
Rapid measurement with readout within about 10 minutes.
Non-invasive detection in the subject using saliva and plasma.
Detection in small sample volumes.
High diagnostic performance reported using clinical saliva/plasma comparison to biopsy genotyping with ROC AUCs (~0.94–0.96).
Documented Applications
Diagnosis of lung cancer using saliva and plasma samples.
Monitoring of lung-cancer-related status.
Treatment selection.
Screening.
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