Method and system for diagnosis and management of gastroesophageal diseases

A method for differentiating between specific gastroesophageal diseases, wherein specific gastroesophageal diseases are selected from erosive reflux disease, non-erosive reflux disease, and gastric cancer, wherein the method comprises:

• (a) taking a saliva sample from an individual suspected of having a gastroesophageal disease of the specific gastroesophageal diseases;
• (b) combining the saliva sample with sodium azide;
• (c) testing the saliva sample to obtain measured levels of EGF, pepsin and one or more additional salivary biomarkers selected from a group consisting of E-cadherin, TGF-α, IL-6, MOB kinase activator 1A, EphA1, MOB kinase Activator 1B, integrin alpha 5, Golgi resident protein GCP 60, FR-beta, protein SEC13 homolog, epiregulin, FGF-12, inhibitor of nuclear factor kappa B kinase catalytic subunit, vimentin, annexin A1, protein S10-A6, malate dehydrogenase, proteasome activator complex subunit 2, cathepsin D light chain, MMP-1, MMP-2, MMP-3, MMP-7, MMP-8, MMP-9, MMP-10, MMP-13, MMP-14, mucin-1, alpha-1-acid glycoprotein, antithrombin, serpin peptidase inhibitor, CTSF, HMGB1, TLR7, COPS2, NT5E, TERF1, TIMP-1, TIMP-2, TIMP-4, XPNPEP2, TGFR2, SIGLEC6, CPE, GHR, GPNMB, SLAMF8, TNFRSF19, TWEAK, IFNGR1, Notch-3, TNFRSF19L, annexin A6, α-defensin-1, caveolin 1, EGF receptor, integrin beta 4, S100A6, S100A8, S100A9, and haptoglobin to create a first biomarker profile;
• and
• (d) comparing the measured levels of the first biomarker profile with reference levels for the salivary biomarkers, wherein a decrease and/or increase in levels of the salivary biomarkers in the first biomarker profile relative to the reference levels is indicative of the gastroesophageal disease.

A system for analysis of a saliva sample obtained from a patient suspected of suffering from a gastroesophageal disease selected from the group consisting of erosive reflux disease, non-erosive reflux disease, and gastric cancer, the system comprising a test strip and a reader;

• wherein the test strip is configured to produce a detectable output at a level proportional to a level present on the test strip of each of EGF, pepsin and one or more additional salivary biomarkers, wherein the additional salivary biomarkers are selected from E-cadherin, TGF-α, IL-6, MOB kinase activator 1A, EphA1, MOB kinase Activator 1B, integrin alpha 5, Golgi resident protein GCP 60, FR-beta, protein SEC13 homolog, epiregulin, FGF-12, inhibitor of nuclear factor kappa B kinase catalytic subunit, vimentin, annexin A1, protein S100-A6, malate dehydrogenase, proteasome activator complex subunit 2, cathepsin D light chain, MMP-1, MMP-2, MMP-3, MMP-7, MMP-8, MMP-9, MMP-10, MMP-13, MMP-14, mucin-1, alpha-1-acid glycoprotein, antithrombin, serpin peptidase inhibitor, CTSF, HMGB1, TLR7, COPS2, NT5E, TERF1, TIMP-1, TIMP-2, TIMP-4, XPNPEP2, TGFR2, SIGLEC6, CPE, GHR, GPNMB, SLAMF8, TNFRSF19, TWEAK, IFNGR1, Notch-3, TNFRSF19L, annexin A6, α-defensin-1, caveolin 1, EGF receptor, integrin beta 4, S100A6, S100A8, S100A9, and haptoglobin;
• wherein after the test strip is exposed to the saliva sample, the reader is configured to read the detectable output;
• and
• wherein when the detectable output indicates that EGF, pepsin, and/or the one or more additional salivary biomarkers meet one or more criteria in a group of criteria, the gastroesophageal disease is indicated.