Diagnostic and prognostic methods for lung disorders using gene expression profiles from nose epithelial cells

Abstract

The present invention provides methods for diagnosis and prognosis of lung cancer using expression analysis of one or more groups of genes, and a combination of expression analysis from a nasal epithelial cell sample. The methods of the invention provide far less invasive method with a superior detection accuracy for lung cancer when compared to any other currently available method for lung cancer diagnostic or prognosis. The invention also provides methods of diagnosis and prognosis of other lung diseases, such as lung cancer.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. application Ser. No. 12 / 940,840, filed en Nov. 5, 2010, which is a continuation of U.S. application Ser. No. 12 / 282,320, filed on Sep. 9, 2008, which is a national stage filing under 35 U.S.C. 371 of international Application PCT / US2007 / 006006, filed Mar. 8, 2007, which claims the benefit under 35 U.S.C. 119(e) from U.S. provisional application Ser. No. 60 / 280,552, filed on Mar. 9, 2006, the content of which is herein incorporated by reference in their entirety. International Application PCT / US2007 / 006006 was published under PCT Article 21(2) in English.GOVERNMENT SUPPORT[0002]The present invention was made, in part, by support from the National Institutes of Health grant No. HL077498. The United States Government has certain rights to the invention.BACKGROUND OF THE INVENTION[0003]1. Field of the Invention[0004]The present invention is directed to methods for diagnosing long diseases from nasal ...

AI Technical Summary

Benefits of technology

[0017]The method provides an optimal means for screening for changes indicating malignancies in individuals who, for example are at risk of developing lung diseases, particularly lung cancers because they have been exposed to pollutants, such as cigarette or cigar smoke or asbestos or any other known pollutant. The method allows screening at a routine annual medical examination because it does not need to be performed by an expert trained in bronchoscopy and it does not require sophisticated equipment needed for bronchoscopy.

[0023]Accordingly, the invention provides a substantially less invasive method for diagnosis, prognosis, and follow-up of lung diseases using samples from nasal epithelial cells. To provide an improved analysis, one preferably uses gene expression analysis.

[0024]One can use analysis of gene transcripts individually and in groups or subsets for enhanced diagnosis for lung diseases, such as lung cancer.

[0052]Alternatively, the diagnosis can separate the individuals, such as smokers, who are at lesser risk of developing lung diseases, such as lung cancer by analyzing from the nasal epithelial cells the expression pattern of the gene groups of the invention provides a method of excluding individuals from invasive and frequent follow ups.

Problems solved by technology

Lung disorders represent a serious health problem in the modern society.

In addition to cigarette smoke, exposure to other air pollutants such as asbestos, and smog, pose a serious lung disease risk to individuals who have been exposed to such pollutants.

Unfortunately survival rates have not changed substantially over the past several decades.

This is largely because there are no effective methods for identifying smokers who are at highest risk for developing lung cancer and no effective tools for early diagnosis.

However, none of these methods provide a combination of both sensitivity and specificity needed for an optimal diagnostic test.

However, the method of sampling epithelial cells from bronchial tissue while less invasive than many other methods has some drawbacks.

Also, if the procedure is performed using a rigid bronchoscope the patient needs general anesthesia involving related risks to the patient.

However, several patients experience uncomfortable sensations, such as a sensation of suffocating during such a procedure and thus are relatively resistant for going through the procedure more than once.

Also, after the bronchoscopy procedure, the throat may feel uncomfortably scratchy for several days.

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