Compostions and methods for diagnosing lung cancers using gene expression profiles
Inventors
Showe, Michael • Showe, Louise C. • Kossenkov, Andrew V.
Assignees
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Publication Number
US-12227808-B2
Publication Date
2025-02-18
Expiration Date
Abstract
Methods and compositions are provided for diagnosing lung cancer in a mammalian subject by use of 7 or more selected genes, e.g., a gene expression profile, from the blood of the subject which is characteristic of disease. The gene expression profile includes 7 or more genes of Table I, Table II, Table III, Table IV or Table IX herein.
Core Innovation
The invention relates to blood-based diagnostic compositions and diagnostic methods for lung cancer using gene expression profiles. The compositions include a set of multiple cDNA polynucleotides, cDNA oligonucleotides, or cDNA ligands that each hybridize to a gene, gene fragment, or gene transcript in a defined group of genes, and the set binds each gene, gene fragment, or gene transcript in the group.
The gene groups are provided in gene tables, including defined classifier lists used to distinguish cancerous tumors from benign nodules in pulmonary diagnostic settings. The described work includes comparing a patient gene expression profile to a reference or control profile to support identification of cancerous tumors versus benign nodules among indeterminate pulmonary nodules.
The compositions and workflows are described with kit embodiments that incorporate the hybridizing cDNA sets with optional detectable labels and detection formats. The document further describes stabilizing blood sample RNA using PAXgene whole blood RNA stabilization tubes and includes assay platforms such as NanoString nCounter and RT-PCR, alongside references to gene panel definitions, marker-panel results, and classifier concepts such as SVM and SVM-RFE.
Claims Coverage
The document includes one independent claim directed to a specific set of hybridizing cDNA components defined by membership in a specified gene group. Dependent claim coverage refines detection by adding a detectable label and further refines kit embodiments by including a blood-holding tube and a reagent that stabilizes the sample, including stabilization of mRNA specifically.
Hybridizing set of cDNA components for a defined gene group
A set of multiple cDNA polynucleotides, cDNA oligonucleotides, or cDNA ligands, each hybridize to a gene, gene fragment, or gene transcript in a specified group of genes, wherein the set binds each gene, gene fragment, or gene transcript in the group.
Detectable labeling of at least one cDNA component
At least one cDNA polynucleotide or cDNA oligonucleotide is attached to a detectable label.
Kit including a blood-holding tube and a sample-stabilizing reagent
The kit includes the set and a tube for holding blood with a reagent that stabilizes the sample.
Reagent stabilizes mRNA in the sample
The kit includes a reagent that stabilizes mRNA in the sample.
Overall claim coverage centers on a defined hybridizing set of cDNA polynucleotides, oligonucleotides, or ligands for a specified gene group, with refinements for detectable labeling and kit packaging that includes a blood-holding tube and a reagent for stabilizing the sample, specifically stabilizing mRNA.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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