Salivary mRNA Profiling, Biomarkers and Related Methods and Kits of Parts

Abstract

A method to detect a biomarker in saliva wherein the biomarker is an extracellular mRNA, comprises detecting the extracellular mRNA in the cell-free saliva; transcriptome analysis of saliva comprises detecting a transcriptome pattern in the cell-free saliva; a method to detect genetic alterations in an organ or in a gene in the organ by analyzing saliva, comprises detecting a transcriptome pattern and/or the mRNA profiling of the gene in cell-free saliva; a method to diagnose an oral or systemic pathology disease or disorder in a subject, comprises: detecting profile of a biomarker associated with the pathology disease or disorder, in particular mRNA and/or protein, in cell-free saliva and/or serum; kits comprising identifier for at least one biomarker for performing at least one of the methods; and use of salivary biomarker salivary and/or serum mRNAs as biomarkers for oral and/or systemic pathology, disease or disorder.

1 . A method to detect an extracellular mRNA in a bodily fluid, the bodily fluid including a cell phase and a fluid phase, the method comprising:
 providing a cell-free fluid phase portion of the bodily fluid; and   detecting the extracellular mRNA in the cell-free fluid phase portion of the bodily fluid,   wherein the bodily fluid is saliva.   
     
     
         2 . The method of  claim 1 , wherein the bodily fluid is unstimulated saliva. 
     
     
         3 . The method of  claim 1  wherein detecting the extracellular mRNA comprises
 isolating the extracellular mRNA from the cell-free fluid phase portion of the bodily fluid and 
 amplifying the extracellular mRNA. 
 
     
     
         4 - 9 . (canceled) 
     
     
         10 . A method to diagnose an oral or systemic pathology, disease or disorder in a subject, the method comprising:
 providing a cell-free fluid phase portion of the saliva of the subject;   detecting in the provided cell-free saliva fluid phase portion an mRNA profile of a gene associated with the pathology, disease or disorder; and   comparing the RNA profile of the gene with a predetermined mRNA profile of the gene, the predetermined mRNA profile of the gene being indicative of the presence of the pathology, disease or disorder in the subject.   
     
     
         11 . The method of  claim 10 , wherein the disease is a cancer of the oral cavity and/or of oropharynx and the gene is selected from the group consisting of the gene coding for IL8, DUSP1, H3F3A, OAZ1, S100P and SAT. 
     
     
         12 . The method of  claim 10 , wherein the disease is a cancer of the oral cavity and/or oropharynx and the gene is the gene coding for 18. 
     
     
         13 . The method of  claim 12 , wherein the disease is oropharyngeal squamous cell carcinoma or head and neck squamous cell carcinoma. 
     
     
         14 - 16 . (canceled) 
     
     
         17 . A method for diagnosing a cancer in a subject, the method comprising:
 providing a bodily fluid of the subject;   detecting in the bodily fluid a profile or a biomarker, the biomarker selected from the group consisting of IL6, H3F3A, TPT1, FTH1, NCOA4 and ARCR,   comparing the profile of the biomarker with a predetermined profile of the biomarker,   recognition in the profile of the biomarker of characteristics of the predetermined profile of the biomarker being diagnostic for the cancer.   
     
     
         18 - 19 . (canceled) 
     
     
         20 . The method of  claim 17 , wherein the cancer is the oropharyngeal squamous cell carcinoma or head and neck squamous cell carcinoma, the biomarker is IL6, the bodily fluid is blood serum and detecting a profile of a biomarker is performed by detecting the protein profile of the biomarker. 
     
     
         21 - 27 . (canceled)