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.

I claim: 
     
         1 . A method for determining a Bcl-2 protein level in a urine sample from a subject, the method comprising:
 (a) obtaining the urine sample from the subject;   (b) contacting the urine sample with a device comprising:
 i) an application zone for receiving a urine sample; 
 ii) a labeling zone containing a binding agent that binds to Bcl-2 protein in the sample; and 
 ii) a detection zone where Bcl-2 protein-bound binding agent is retained to give a signal that indicates that Bcl-2 protein level in the urine sample is lower than a threshold level and to give a different signal that indicates that Bcl-2 protein level in the urine sample is at or above the threshold level; 
 and 
   (c) detecting a signal from the detection zone of the device to determine the Bcl-2 protein level in the urine sample.   
     
     
         2 . The method of  claim 1 , wherein said threshold concentration is between 0.1 ng/ml and 2.0 ng/ml. 
     
     
         3 . The method of  claim 1 , wherein said threshold concentration is 1.8 ng/ml. 
     
     
         4 . The method of  claim 1 , wherein the binding agent is a monoclonal or polyclonal antibody that binds to Bcl-2 protein. 
     
     
         5 . The method of  claim 1 , wherein said detecting of (b) further comprises linking or incorporating a label onto the binding agent. 
     
     
         6 . A method of accurately screening for ovarian cancer in a subject, the method comprising detecting Bcl-2 protein level in a urine sample from the subject according to the method of  claim 1 , and
 a) identifying the presence of ovarian cancer in the subject based on the level of Bcl-2 protein in the urine sample from the subject being above the threshold level, or   b) identifying the absence of ovarian cancer in the subject based on the level of Bcl-2 protein in the urine sample from the subject being below the threshold level.   
     
     
         7 . A method of accurately screening for ovarian cancer in the subject, the method comprising detecting the Bcl-2 protein level in the urine sample from the subject according to the method of  claim 3 , and
 a) identifying the presence of ovarian cancer in the subject based on the level of Bcl-2 protein in the urine sample from the subject being above the threshold level, or   b) identifying the absence of ovarian cancer in the subject based on the level of Bcl-2 protein in the urine sample from the subject being below the threshold level.   
     
     
         8 . A kit for detection of Bcl-2 in urine, comprising a Bcl-2 detection device and printed instructions for using the device to detect Bcl-2 in urine according to the method of  claim 1 .