Bladder Cancer Test Exhibits 99% Specificity

In a study of patients with symptoms of bladder cancer, a new bladder cancer test has demonstrated specificity of 99% and sensitivity of 88.5%. The study was published in the July 2001 issue of the Journal of Urology.

The study involved 608 patients, of whom 87% had no previous diagnosis of bladder cancer and 13% had a known history of bladder cancer. When patients from six clinical categories were excluded, the positive predictive value improved from 34.1% to 92.0%, and negative predictive value remained constant at 90.8%, indicating that no additional tumors were missed by the exclusion criteria.

The test, called NMP22, was developed by Matritech Inc. (Newton, MA), based on the company's nuclear matrix protein (NMP) technology, which measures the level of a specific nuclear matrix protein associated with bladder cancer. Clinical studies have shown NMP22 to be twice as sensitive as conventional urine cytology in detecting low-grade bladder cancer tumors, says Matritech. Since the test uses voided urine samples, it is noninvasive and painless. The test has been cleared by the U.S. Food and Drug Administration (FDA) for use as an aid in testing previously undiagnosed patients who have symptoms or are at risk for bladder cancer.

"By excluding clinical categories that produce false-positive results, the specificity and positive predictive value of the NMP22 test were significantly improved while maintaining excellent sensitivity,” said Craig Zippe, co-director of the Urological Institute at the Cleveland Clinic (OH, USA) and principal investigator.




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