Organ specific diagnostic panels and methods for identification of organ specific panel proteins
OwnerXiao-Jun Li, Paul Edward Kearneyinventors
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Abstract
The present application provides novel compositions, methods, and assays for use in identification of appropriate diagnostic markers in blood. These compositions, methods, and assays are capable of distinguishing normal levels of detectable markers from changes in marker levels that are indicative of changes in health status.
Claims33
A method for predicting a risk for development of a disease or change in health status comprising:
- (a) obtaining a sample from a subject;
- (b) measuring the presence or absence of a set of sample organ specific panel proteins;
- (c) comparing the expression levels of the sample organ specific panel protein set to predetermined expression levels of an identical set of organ specific panel proteins from a control population;
- (d) determining the expression level differences between the sample organ specific panel protein set and the predetermined expression levels of the control population organ specific panel protein set;
A method for diagnosing a disease, condition or change in health status comprising:
- (a) obtaining a sample of organ specific panel gene products from a subject;
- (b) measuring the presence or absence of a set of sample organ specific panel gene products selected from the organ specific panel genes provided in Tables 1-4;
- (c) comparing the levels of the set of sample organ specific panel gene products to a predetermined control range for each organ-specific gene product;
- and
- (d) diagnosing a disease, condition or change in health status based upon the difference between levels of the set of sample organ specific panel gene products and the predetermined control range for each organ specific panel gene product.
The method of claim 25, wherein the plurality of detection reagents are selected from the group consisting of antibodies, capture agents, multi-ligand capture agents and aptamers.
A method for identifying a panel of disease-associated organ specific panel gene products, comprising:
- (a) obtaining a biological sample from a subject determined to have a disease affecting a selected organ;
- (b) detecting a first level of one or more organ specific panel gene products selected from any one or more of the organ specific panel genes provided in Tables 1-4 in the biological sample;
- (c) comparing the first level of the one or more organ specific panel gene products to a predetermined control range;
- (d) selecting one or more gene products as a member of the panel of disease-associated organ specific panel gene products when the first level of one or more of the organ specific panel gene products in the biological sample is above or below the corresponding predetermined control range.
A method for generating a predetermined control range for one or more organ specific panel gene products comprising the steps of:
- (a) identifying one or more organ specific panel gene products using sequencing by synthesis;
- (b) measuring the level of the one or more organ specific panel gene product in a set of specific healthy organs;
- (c) determining a set of standard values for the one or more organ specific panel gene product that is the predetermine control range;
- wherein the predetermined control rage is compared to a biological sample from a subject to determine the health status of the subject.
A method for identifying a subject at risk for the development of lung cancer comprising:
- (a) obtaining a sample from a subject;
- (b) measuring expression levels of CLDN18, CPB2, WIF1, PPBP, and ALOX15B;
- and
- (c) predicting that the subject is at risk for development of non-small cell lung cancer based upon the presence of CLDN18, CPB2, WIF1, PPBP, and ALOX15B in the sample.
A method for diagnosing lung cancer comprising:
- (a) obtaining a sample from a subject;
- (b) measuring expression levels of CLDN18, CPB2, WIF1, PPBP, and ALOX15B;
- and
- (c) predicting that the subject is at risk for development of non-small cell lung cancer based upon the expression level of CLDN18, CPB2, WIF1, PPBP, and ALOX15B in the sample.
Dependencies are inferred from the claim text.