Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Assignees
Helio Health Inc • University of California San Diego UCSD
University of California, San Diego (UCSD)The University of California, San Diego (UCSD) is a leading public research university located in La Jolla, California. Known for its innovative and interdisciplinary approach, UCSD offers a wide range of undergraduate, graduate, and professional programs across various fields. The university is committed to fostering a diverse and inclusive community, promoting sustainability, and driving social mobility through education, research, and public service. UCSD is recognized for its contributions to research and innovation, particularly in areas such as climate science, health innovation, and artificial intelligence.
The University of California, San Diego (UCSD) is a leading public research university located in La Jolla, California. Known for its innovative and interdisciplinary approach, UCSD offers a wide range of undergraduate, graduate, and professional programs across various fields. The university is committed to fostering a diverse and inclusive community, promoting sustainability, and driving social mobility through education, research, and public service. UCSD is recognized for its contributions to research and innovation, particularly in areas such as climate science, health innovation, and artificial intelligence.
Publication Number
US-12359258-B2
Publication Date
2025-07-15
Expiration Date
2037-07-06
Abstract
Disclosed herein are methods and kits for identifying a subject as having lung cancer. Also provided herein are methods and kits for determining the prognosis of a subject having lung cancer and for determining the progression of lung cancer in a subject.
Core Innovation
The invention provides methods and kits for identifying a subject as having lung cancer, determining the prognosis of a subject having lung cancer, and monitoring the progression of lung cancer in a subject. These methods utilize DNA methylation profiling of genomic DNA extracted from a biological sample obtained from the subject suspected of having lung cancer. Key biomarkers comprising specific CpG sites are used to generate methylation profiles, which are compared to controls to identify lung cancer or evaluate prognosis and progression.
The problem solved addresses the need for earlier and less invasive lung cancer diagnosis, better prognosis determination, and effective monitoring of cancer progression. Current diagnostic procedures often begin only after symptoms present, involving costly, invasive, and sometimes time-consuming methods with inaccuracies due to inaccessible tumor sites. Late diagnosis contributes to high cancer morbidity and mortality. The invention improves diagnostic sensitivity and specificity through methylation profiling and supports clinical decision-making for treatment initiation or modification.
Claims Coverage
The patent contains one independent claim focusing on a method of treating lung cancer based on methylation analysis of cfDNA at a specific biomarker.
Methylation profiling of cfDNA using next-generation sequencing at biomarker cg10673833
The method includes obtaining treated genomic DNA from a cfDNA sample, performing next-generation sequencing, mapping sequencing reads to a reference genome to determine methylation status specifically at cg10673833, and generating a methylation profile based on this data.
Identification of lung cancer via methylation profile comparison
Identifying the subject as having lung cancer by comparing the methylation profile of cg10673833 to a control methylation profile.
Administering therapeutic agents upon lung cancer identification
Administering an effective amount of a therapeutic agent selected from a defined group including alectinib, afatinib, bevacizumab, carboplatin, ceritinib, crizotinib, docetaxel, doxorubicin, erlotinib, everolimus, gefitinib, gemcitabine, mechlorethamine hydrochloride, methotrexate, necitumumab, nivolumab, paclitaxel, pembrolizumab, ramucirumab, vinorelbine tartrate, or combinations thereof, to the identified lung cancer subject.
Use of specific types of lung cancer and sample sources
The lung cancer types include relapsed, refractory, metastatic lung cancer, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), bronchial carcinoids, and mesothelioma, with NSCLC subtypes being adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or large cell neuroendocrine tumors. The sample source for cfDNA includes blood samples.
Processing of genomic DNA with deaminating agents and hybridization with methylation probes
The method involves treating extracted genomic DNA with a deaminating agent (e.g., bisulfite), and hybridizing with probes specific to methylated and unmethylated forms of cg10673833, followed by sequencing. The next-generation sequencing technique can be digital PCR sequencing.
The claims cover a method of lung cancer treatment initiated by methylation-based diagnosis using next-generation sequencing of cfDNA, focused on specific methylation markers, especially cg10673833, and include steps for DNA processing, methylation determination, cancer identification, and administration of therapeutic agents tailored to lung cancer types and patient prognosis.
Stated Advantages
The disclosed DNA methylation profiling methods provide higher clinical sensitivity and dynamic range compared to somatic mutation analysis for lung cancer detection.
The methylation signatures correlate with prognosis and treatment response, enabling personalized therapeutic decisions.
The methods allow for less invasive, earlier diagnosis and better monitoring of lung cancer progression.
Documented Applications
Diagnosing and identifying subjects as having lung cancer through methylation profiling of cfDNA or tissue biopsy samples.
Determining prognosis of subjects having lung cancer by generating methylation profiles to predict survival time and treatment response.
Monitoring progression or remission of lung cancer in subjects by tracking methylation score changes over time.
Selecting appropriate therapeutic agents and adjusting treatment dosage based on methylation profiling and prognosis assessment.
Interested in licensing this patent?