Compositions, methods and kits for diagnosis of lung cancer
Inventors
Kearney, Paul E. • Fang, Kenneth C. • Li, Xiao-Jun • Hayward, Clive • SPICER, Douglas
Assignees
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Publication Number
US-11913957-B2
Publication Date
2024-02-27
Expiration Date
Abstract
Methods are provided for identifying biomarker proteins that exhibit differential expression in subjects with a first lung condition versus healthy subjects or subjects with a second lung condition. Also provided are compositions comprising these biomarker proteins and methods of using these biomarker proteins or panels thereof to diagnose, classify, and monitor various lung conditions. The methods and compositions provided herein may be used to diagnose or classify a subject as having lung cancer or a non-cancerous condition, and to distinguish between different types of cancer (e.g., malignant versus benign, SCLC versus NSCLC).
Core Innovation
The invention relates to blood-based multiplex protein biomarker methods for pulmonary nodule management. A panel of proteins present in a blood sample is measured by immunoassay to provide expression-level measurements used to determine a probability of lung cancer score. The approach is directed to determining whether a pulmonary nodule is associated with lung cancer, including malignant vs benign and SCLC vs NSCLC.
A specific protein panel comprises LG3BP and C163A. The determined score is used as a decision basis for treatment selection, including rule-out or rule-in treatment protocol decisions for subjects with pulmonary nodules. A predetermined score threshold identifies a subject for treatment by surgery, chemotherapy, radiotherapy, or any combination thereof.
The disclosed approach is grounded in developing and validating a blood-based classifier for lung nodules, including refinement to a final classifier and use of classifier performance metrics. Validation is described with negative predictive value, specificity, high-sensitivity region performance, ROC/AUC, and rule-out risk requirements.
Claims Coverage
The independent claim covers a treatment method for a pulmonary nodule based on an immunoassay of blood protein expression for a lung cancer probability score, with treatment triggered when the score is at or above a predetermined threshold. The claim includes three core inventive features.
Immunoassay of blood protein panel including LG3BP and C163A
Performing an immunoassay to measure expression levels of a panel of proteins present in a blood sample of the subject, wherein the panel comprises LG3BP and C163A.
Lung cancer probability score determination from measurements
Determining a probability of lung cancer score based on the measurements.
Threshold-based treatment of pulmonary nodule
Treating the subject having a score that is equal to or greater than a predetermined score by surgery, chemotherapy, radiotherapy, or any combination thereof.
Overall claim coverage is centered on using a blood-based immunoassay measuring a protein panel that comprises LG3BP and C163A to generate a lung cancer probability score, and using a predetermined score threshold to direct treatment of a pulmonary nodule via surgery, chemotherapy, radiotherapy, or combinations thereof.
Stated Advantages
Provides a lung cancer score probability from blood-sample protein measurements for pulmonary nodule management.
Enables rule-out or rule-in treatment protocol decisions using a predetermined score threshold.
Supports differentiation-related classification context, including malignant vs benign and SCLC vs NSCLC.
Uses performance metrics described in the provided content, including ROC/AUC, negative predictive value, specificity, and rule-out risk requirements.
Classifier performance is characterized as independent from nodule size and smoking history.
Documented Applications
Treatment of a pulmonary nodule in a subject, where the decision is guided by an immunoassay-measured protein panel including LG3BP and C163A and a lung cancer score threshold.
Clinical nodule assessment context including pulmonary function test (PFT), pulmonary imaging, and biopsy.
Pulmonary imaging modality examples include x-ray, chest CT, and PET.
Multisite matched study use for pulmonary nodules and diagnostic triage concepts for ruling out vs rule-in malignancy using probability-score thresholds.
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