Patent Document ID: 20150269311
Application ID: 14435991
Patent Flag: 0

Claim One:
1. A method of defining the likelihood of a subject having bladder cancer, comprising the steps of: (A) assessing the subject's likelihood of having bladder cancer by: i. identifying at least one sub-population group appropriate to the subject; ii. determining the level of one or more biomarkers selected according to the sub-population group in a sample obtained from the subject; iii. inputting each of the biomarker values into an algorithm to produce an output value; and iv. correlating the output value with the likelihood of the subject having bladder cancer, wherein the sub-population group is selected according to smoking habits, gender, presence/absence of stone disease, history of benign prostate enlargement (BPE) or prescription of anti-hypertensive, anti-platelet and/or anti-ulcer medication, and (B) determining the subject's stratified risk level of serious disease by: v. determining the level of one or more biomarkers specific for one or more risk classifiers defined using Random Forest Classifiers (RFC), logistic regression or another appropriate systems biology or statistical approach in a sample obtained from the subject, vi. inputting each of the biomarker values into an algorithm or algorithms to produce an output value; and vii. correlating the output value with a stratified risk level of underlying serious disease, wherein the likelihood of having bladder cancer is combined with the stratified risk level of having serious disease, wherein the risk of having bladder cancer and/or serious disease is categorized as: high-risk bladder cancer requiring immediate cystoscopy; low-risk bladder cancer requiring urgent cystoscopy; high-risk control requiring close evaluation and further investigation; or low-risk control requiring primary care monitoring, and wherein: if the smoker sub-population is selected, the level of the biomarkers CRP, EGF, MMP9, IL-1α, IL-4, TM and IL-2 is determined in step (ii); if the non-smoker sub-population is selected, the level of the biomarkers TNFα, sTNFR1, IL-6, IL-1α, MMP9/NGAL complex and CEA is determined in step (ii) and the creatinine level in the sample is also determined; if the gender sub-population is selected and the subject is male, the level of the biomarkers CRP, EGF, CK18, Th-1β, IL-8 and IL-2 is determined in step (ii) and the creatinine level in the sample is also determined; if the gender sub-population is selected and the subject is female, the level of the biomarkers CRP, EGF, IL-6, dDimer, MMP9/NGAL complex and CEA is determined in step (ii) and the osmolarity of the sample is also determined; if the stone disease sub-population is selected and the subject is positive for stone disease, the level of the biomarkers CRP sTNFR1 CK18, IL-1α, IL-8 and VEGF is determined in step (ii) and the creatinine level in the sample is also determined; if the stone disease sub-population is selected and the subject is negative for stone disease, the level of the biomarkers CRP, EGF, IL-6, IL-1α, MMP9/NGAL complex and CEA is determined in step (ii) and the creatinine level in the sample is also determined; if the BPE sub-population is selected and the subject is positive for BPE, the level of the biomarkers CRP, EGF, IL-6, IL-1α, MMP9/NGAL complex, TM and CEA is determined in step (ii); if the BPE sub-population is selected and the subject is negative for PBE, the level of the biomarkers CRP, EGF, CK18, NGAL, MMP9/NGAL complex and BTA is determined in step (ii) and the creatinine level in the sample is also determined; if the anti-hypertensive medication sub-population is selected and the subject is positive for anti-hypertensive medication, the level of the biomarkers TNFα, EGF, IL-6, MMP9/NGAL complex and CEA is determined in step (ii) and the creatinine level and total protein level in the sample is also determined; if the anti-hypertensive medication sub-population is selected and the subject is negative for anti-hypertensive medication the level of the biomarkers TNFα, sTNFR1, IL-6, NGAL, IL-8, TM and CEA is determined in step (ii); if the anti-platelet medication sub-population is selected and the subject is positive for anti-platelet medication, the level of the biomarkers TNFα, EGF, IL-6, IL-8 and CEA is determined in step (ii) and the total protein level and osmolarity of the sample is also determined; if the anti-platelet medication sub-population is selected and the subject is negative for anti-platelet medication, the level of the biomarkers CRP, EGF, MCP-1, MMP9/NGAL complex, TM and FPSA is determined in step (ii) and the total protein level of the sample is also determined; if the anti-ulcer medication sub-population is selected and the subject is positive for anti-ulcer medication, the level of the biomarkers CRP, EGF, IL-6, IL-1α, IL-8, TM and CEA is determined in step (ii); and if the anti-ulcer medication sub-population is selected and the subject is negative for anti-ulcer medication, the level of the biomarkers CRP, EGF, vWF, IL-1β, MMP9/NGAL complex, TM and HA is determined in step (ii).