Increased Accuracy of Matritech's Bladder Cancer Test Kit

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Description And Advantages

Matritech Inc, the cancer diagnosis company, announced that a study of 608 patients presenting with symptoms of bladder cancer demonstrated, when certain exclusion criteria were used, increased specificity and positive predictive values of the NMP22 bladder cancer test kit. The results of the study have been published in the July issue of the Journal of Urology.

"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 at the Cleveland Clinic Foundation's Urological Institute and principal investigator of the study. "With the application of these exclusion criteria, the NMP22 assay approximates more closely the reference standard of an ideal tumor marker, which is a test that yields sensitivity and specificity of 90 percent."

Of the 608 patients who enrolled in the study, 87 per cent (529) presented with no previous diagnosis of bladder cancer, and 13 per cent (79) were being monitored with a known history of bladder cancer. When patients from six exclusion categories were excluded, sensitivity of the NMP22 test kit remained unchanged at 88.5 per cent, but specificity improved from 83.9 per cent to 99.2 per cent. The positive predictive value improved from 34.1 per cent to 92.0 per cent, and negative predictive value remained constant at 90.8 per cent, indicating that no additional tumors were missed by the application of the exclusion criteria.

"The results of this study further validate our belief that the NMP22 test kit is a highly accurate fluid-based testing method for the screening and monitoring of bladder cancer," said David L. Corbet, President and Chief Operating Officer of Matritech. "Consequently, it is our opinion that NMP22 should be an integral component of the diagnostic process of every patient evaluated for bladder cancer."

Matritech's NMP22 Test Kit measures the level of a specific nuclear matrix protein associated with bladder cancer to accurately detect disease. Clinical studies by leading urologists have shown NMP22 to be twice as sensitive as conventional urine cytology in detecting low-grade bladder cancer tumors. NMP22 employs voided urine samples and is thus non-intrusive and pain- free. While NMP22 has been used as a monitoring tool to predict disease recurrence since 1996, in 2000 the test was cleared by the Food and Drug Administration for expanded use as an aid in testing previously undiagnosed individuals who have symptoms of or are at risk for bladder cancer. Matritech is developing a point-of-care for- mat of the NMP22 test kit.

Matritech's nuclear matrix protein (NMP) core technology correlates levels of NMPs in body fluids to the presence of cancer. Multiple published clinical studies have validated this ability of NMPs to detect early stage cancerous abnormalities. Matritech has a pipeline of NMP-based products in development for the detection of major cancers including bladder, cervical, breast, colon and prostate cancers. The NMP22 test kit is cleared for marketing in the United States for management and screening of individuals at risk of bladder cancer. It also is sold in China, Europe and Japan where it is approved for bladder cancer screening.


Pharmabiz, August 2, 2001