BTA stat® Test

The BTA stat® Test is a non-invasive test used to detect bladder cancer in human urine. It uses monoclonal antibodies to detect the presence of bladder tumor-associated antigen in urine. For the lab, it is a simple, one-step test that has a 5-minute read time. BTA stat® is used in conjunction with cystoscopy for monitoring patients who have a history of bladder cancer.

The BTA stat® test is used for the early detection of recurrent bladder cancer. It detects early stage and low-grade cancers that cytology often misses. This helps to provide early treatment and improved survival rates. 

The urine sample is collected by the patient in a clean, plastic container provided by a healthcare professional. After transferring five drops of urine to the BTA-stat device using only 5 drops of urine. The BTA stat® test detects a substance released into the urine by bladder cancer cells. The presence of this substance in urine will cause a colored line to form on the BTA stat device, which indicates a positive result. The BTA stat® test can be performed by a healthcare professional or, with a prescription, by a patient at home. 

Any person who has been diagnosed with bladder cancer and is under a doctor’s care can benefit from the BTA stat® Test. 

This depends on the patient’s condition and risk. Hence, a doctor will determine how often to run the test. 

The BTA stat test was evaluated by testing bladder cancer patients, in different cities. The test results were accurate in most patients; it detected 9 out of 10 early stage cancers. The test was negative only in 19 out of 20 healthy people. However, other conditions can also cause positive results. BTA stat test is also FDA cleared for use in a physician’s office and for prescription use at home.

Product features:​

• Uses monoclonal antibodies to detect the presence of bladder tumor-associated antigen in urine
• Detects early-stage / grade cancers that cytology often misses.
• Returns fast, objective result – a line in the patient window indicates a positive result
• Requires only one voided urine sample, with no sample preparation
• Adjunct test to cystoscopy