Detection of cancer by elevated levels of bcl-2

Abstract

The present invention relates to a method for the diagnosis, prognosis, and monitoring of cancer, such as early or late stage ovarian cancer, in a subject by detecting Bcl-2 in a biological sample from the subject, preferably a urine or blood sample. Bcl-2 may be measured using an agent that detects or binds to Bcl-2 protein or an agent that detects or binds to encoding nucleic acids, such as antibodies specifically reactive with Bcl-2 protein or a portion thereof. The invention further relates to kits for carrying out the methods of the invention. The invention further relates to a device for the rapid detection of Bcl-2 in a bodily fluid and methods for rapidly measuring Bcl-2 in a bodily fluid.

1 . A device for the rapid detection of Bcl-2 in a sample of urine, comprising an application zone for receiving a urine sample; a labeling zone containing a binding agent that binds to Bcl-2 in the sample; and a detection zone where Bcl-2-bound binding agent is retained to give a signal, wherein the signal given for a sample from a subject with a Bcl-2 level lower than a threshold concentration is different from the signal given for a sample from a subject with a Bcl-2 level greater than a threshold concentration. 
     
     
         2 . The device of  claim 1 , wherein said threshold concentration is between 0 ng/ml and 2.0 ng/ml. 
     
     
         3 . The device of  claim 1 , wherein said threshold concentration is 1.8 ng/ml. 
     
     
         4 . The device of  claim 1 , wherein the device has a reference zone which gives a signal which has the same intensity as the signal given in the detection zone for a sample from a subject having a Bcl-2 level equal to the threshold concentration. 
     
     
         5 . The device of  claim 1 , wherein the binding agent is a tagged antibody. 
     
     
         6 . The device of  claim 5 , wherein the antibody is tagged with colloidal gold. 
     
     
         7 . The device of  claim 1 , wherein the detection zone comprises an immobilized anti-Bcl-2 antibody. 
     
     
         8 . The device of  claim 1 , wherein the device has a control zone downstream of the detection zone which retains binding agent which passes through the detection zone. 
     
     
         9 . The device of  claim 1 , wherein the control zone and the reference zone are the same zone. 
     
     
         10 . The device of  claim 1 , wherein the binding agent is a tagged monoclonal antibody. 
     
     
         11 . A method for measuring Bcl-2 in urine, comprising: (a) obtaining urine from a subject; (b) contacting the urine with a device according to  claim 1 ; and (c) detecting a signal from the detection zone of the device, whereby the signal conveys information about Bcl-2 concentration in the urine. 
     
     
         12 . The method of  claim 11 , wherein said threshold concentration is between 0 ng/ml and 2.0 ng/ml. 
     
     
         13 . The method of  claim 11 , wherein said threshold concentration is between 1.8 ng/ml. 
     
     
         14 . A kit for detection of Bcl-2 in urine, comprising a device according to  claim 1 , and printed instructions for using the device to detect Bcl-2 in urine.