公开(公告)号：US09892229B2

公开(公告)日：2018-02-13

申请号：US14435991

申请日：2013-10-16

Applicant: RANDOX LABORATORIES LTD.

Inventor： Mark William Ruddock ,  Cherith N. Reid ,  Kate E. Williamson ,  Frank Emmert-Streib ,  John V. Lamont ,  Peter Fitzgerald

IPC: G01N33/48 ,  G06F19/18 ,  G01N33/574 ,  G06F19/24 ,  G06F19/00 ,  G06G7/58

CPC classification number: G06F19/18 ,  G01N33/57407 ,  G01N33/57484 ,  G01N2333/4737 ,  G01N2333/4742 ,  G01N2333/475 ,  G01N2333/485 ,  G01N2333/523 ,  G01N2333/525 ,  G01N2333/5406 ,  G01N2333/5412 ,  G01N2333/5421 ,  G01N2333/545 ,  G01N2333/55 ,  G01N2333/70578 ,  G01N2333/70596 ,  G01N2333/7151 ,  G01N2333/7452 ,  G01N2333/928 ,  G01N2333/96433 ,  G01N2333/96494 ,  G01N2333/988 ,  G01N2400/00 ,  G06F19/00 ,  G06F19/24 ,  G16H50/30

Abstract: The invention provides 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.

公开(公告)号：US20150269311A1

公开(公告)日：2015-09-24

申请号：US14435991

申请日：2013-10-16

Applicant: RANDOX LABORATORIES LTD.

Inventor： Mark William Ruddock ,  Cherith N. Reid ,  Kate E. Williamson ,  Frank Emmert-Streib ,  John V. Lamont ,  Peter Fitzgerald

IPC: G06F19/18 ,  G06F19/24 ,  G06F19/00 ,  G01N33/574

CPC classification number: G06F19/18 ,  G01N33/57407 ,  G01N33/57484 ,  G01N2333/4737 ,  G01N2333/4742 ,  G01N2333/475 ,  G01N2333/485 ,  G01N2333/523 ,  G01N2333/525 ,  G01N2333/5406 ,  G01N2333/5412 ,  G01N2333/5421 ,  G01N2333/545 ,  G01N2333/55 ,  G01N2333/70578 ,  G01N2333/70596 ,  G01N2333/7151 ,  G01N2333/7452 ,  G01N2333/928 ,  G01N2333/96433 ,  G01N2333/96494 ,  G01N2333/988 ,  G01N2400/00 ,  G06F19/00 ,  G06F19/24 ,  G16H50/30

Abstract: The invention provides 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 categorised 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.

Abstract translation: 本发明提供了一种定义患有膀胱癌的受试者的可能性的方法，包括以下步骤：（A）通过以下步骤评估受试者患膀胱癌的可能性：i。 识别适合于该受试者的至少一个亚群体群体; ii。 确定从受试者获得的样品中根据亚群体组选择的一种或多种生物标志物的水平; iii。 将每个生物标记值输入到算法中以产生输出值; 和iv。 将输出值与患有膀胱癌的患者的可能性相关联，其中根据吸烟习惯，性别，存在/不存在石头疾病，良性前列腺增生病史（BPE）或抗高血压药物处方选择亚群体组 ，抗血小板和/或抗溃疡药物，以及（B）通过以下方式确定受试者的严重疾病分层风险水平：v。确定一个或多个特定于使用随机森林分类器定义的风险分类器的生物标志物的水平 RFC），逻辑回归或从该主题获得的样本中的其他适当的系统生物学或统计学方法，vi。 将每个生物标记值输入算法或算法以产生输出值; 和vii。 将输出值与潜在严重疾病的分层风险水平相关联，其中膀胱癌的可能性与具有严重疾病的分层风险水平相结合，其中具有膀胱癌和/或严重疾病的风险被分类为：高 膀胱癌需要立即膀胱镜检查; 低危膀胱癌需要紧急膀胱镜检查; 高风险控制需要进行密切的评估和进一步的调查; 或需要初级保健监测的低风险控制。