Sylvester Comprehensive Cancer Center

Simple, Inexpensive Doctor’s Office Test Can Reliably Detect Bladder Cancer

02.15.2005

A study showing dramatically improved results detecting bladder cancer with a simple urine test will be published in the February 16 issue of the Journal of the American Medical Association. The new test detects a nuclear matrix protein, NMP22, which is secreted by bladder tumors into the urine.

If detected early, bladder cancer is highly curable, with 95 percent of patients surviving five years or more. But about one in four patients is not diagnosed until the cancer has spread, cutting survival in half. Until now, there has not been a simple in-office test to reliably diagnose this disease.

“It’s important because too often we see men and women who have blood in the urine or symptoms that could be bladder cancer treated for infections for several months before they’re diagnosed,” said Mark S. Soloway, M.D., chairman of the Department of Urology at the University of Miami Leonard M. Miller School of Medicine. “Unfortunately, those months can make a significant difference in the ability to cure those cancers.”

Traditionally, there are three tests that are used together to diagnose this disease: an x-ray evaluation of the kidneys and ureter, which is the tube leading from the kidneys to the bladder, a visual examination of the bladder and urethra with a small viewing tube called a cystoscope, and a urine test in which a pathologist looks for cancer cells under a microscope, called cytology. According to the study, the protein test was more than three times as sensitive as traditional cytology in detecting the presence of cancer in the urine, although it detected false positives slightly more often.

Researchers at 23 institutions in ten states, including the Miller School of Medicine, the University of Texas M.D. Anderson Cancer Center, the University of Rochester Medical Center, and community physicians, examined 1,331 patients who were considered high-risk for bladder cancer. Risk factors include smoking, people in high-risk occupations like firefighters and chemical workers, and those presenting with certain symptoms, including blood in the urine and pain while urinating. Of the 1,331 patients, 79 were diagnosed with bladder cancer. The NMP22 assay indicated bladder cancer in 44 patients – cytology detected cancer in 12 patients.

Based on Medicare reimbursement rates, the cost for traditional cytology is approximately $56, while the NMP22 test is $24. “This test is very simple, it’s very fast, it’s affordable – much cheaper and faster than cytology,” said Soloway. Results are available in the office in minutes. “You put urine in a well, put a strip in there and it makes a color. It’s fast, easy and accurate.”

“Until very recently there have not been any simple, in-office tests to diagnose bladder cancer,” said Soloway. “Now we have two.” The NMP22 test is widely available as the NMP22®BladderChek® Test from Matritech. Polymedco offers the BTA stat® Test, a second in-office urine test which identifies a bladder tumor association antigen in urine.

Approximately 60,000 Americans will be diagnosed with bladder cancer this year, and nearly 13,000 will die. In Florida, about 4,500 people will be diagnosed with the disease and nearly 1,000 will die. Bladder cancer is the fifth most common cancer in men, eighth most common in women and is largely correlated with cigarette smoking. “If someone is a smoker over 50 they should consider being tested,” said Soloway.

After 4 p.m. on Tuesday, February 15, the study will be available online at http://www.jama.com.

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