US 11,054,426 B2
Diagnostic method
David Galloway, Aberdeen (GB); and Nick Coleman, Cambridge (GB)
Filed by Cytosystems Ltd, York (GB)
Filed on Oct. 23, 2018, as Appl. No. 16/168,096.
Application 16/168,096 is a continuation in part of application No. 13/512,585, granted, now 10,107,814, previously published as PCT/GB2012/000008, filed on Jan. 6, 2012.
Claims priority of application No. 1100223 (GB), filed on Jan. 7, 2011.
Prior Publication US 2019/0056401 A1, Feb. 21, 2019
This patent is subject to a terminal disclaimer.
Int. Cl. G01N 33/50 (2006.01); G01N 33/574 (2006.01)
CPC G01N 33/57407 (2013.01) [G01N 2333/914 (2013.01); G01N 2800/54 (2013.01)] 9 Claims
 
1. A method of detecting a subject suffering from, or at risk of suffering from, bladder cancer, the method comprising
i) providing a urine sample isolated from a subject;
ii) isolating cells from said sample to provide a cell sample;
iii) contacting the sample with a specific binding member capable of binding to a minichromosome maintenance 2 (MCM2) polypeptide;
iv) determining the binding of said specific binding member to the cell sample;
v) counting those cells in said cell sample which bound to said specific binding member to provide a cell count; and,
vi) determining, based on the cell count, whether the subject has, or is at risk of having, bladder cancer;
wherein said determining step (vi) is based upon a measurement of MCM2 labelled cells relative to a threshold number, wherein said measurement above or equal to said threshold is indicative of bladder cancer or a risk of bladder cancer, and wherein the threshold number is about 30 to 50 cells or about 50 to 200 cells when the subject has previous evidence of bladder cancer.