Matritech: Study shows BladderChek Test greatly increases detection of recurrent bladder cancer

By E. Janene Geiss

Philadelphia, Jan. 17 - Matritech said Tuesday that a study of 668 patients showed the NMP22 BladderChek Test was found to significantly increase the detection of recurrent bladder cancer, finding 99% of the malignancies when used with cystoscopy.

The study included patients with a history of bladder cancer and was conducted at 23 clinical sites in nine states, including academic, private practice and veterans' facilities, according to a company news release.

The study was designed to investigate whether the NMP22 point-of-care test could improve detection of recurrence of a bladder malignancy in the routine monitoring of patients with a prior history of bladder cancer.

Patients provided a urine sample for analysis of NMP22 protein and cytology prior to cystoscopy. Testing for the NMP22 tumor marker was conducted in a blinded manner, officials said.

"Because bladder cancer has a very high recurrence rate, we need to monitor patients vigilantly. Adding the NMP22 test to routine monitoring provides an extra measure of confidence. This test has important advantages over other methods: it provides results while the patient is at the doctor's office. And as a molecular marker, it can detect cancers that might be missed visually without requiring intact cells. No other test is FDA approved for both diagnosis and monitoring that can be used during a patient visit and costs less than cytology," H. Barton Grossman of the the M.D. Anderson Cancer Center, said in the release.

When used in combination with cystoscopy, a visual examination of the bladder, the NMP22 BladderChek test detected 99% of bladder malignancies compared to 91% for cystoscopy alone, officials said.

The BladderChek test was positive for eight of nine cancers not seen by cystoscopy, including seven tumors that were aggressive or advanced, officials said.

The BladderChek test also detected four times as many cancers as the commonly used laboratory-based urine cytology test, officials added.

Results of the study were published in the Jan. 18 issue of the Journal of the American Medical Association.

Clinical investigators noted that it is an inexpensive and a cost-effective tool, proven to detect significantly more cancers than urine cytology and at half the cost.

Bladder cancer has the highest rate of recurrence of any malignancy, with the cancer recurring in 50% to 90% of patients, depending on the aggressiveness and extent of the initial tumor. Patients are rigorously monitored throughout their lives for new malignancies. A combination of methods is used to monitor patients since no single method is 100% accurate in detecting the cancer, officials said.

Developed and commercialized by Matritech, the NMP22 BladderChek Test is the only noninvasive point-of-care assay approved by the FDA as an aid in both the initial diagnosis and monitoring of bladder cancer. Using only four drops of urine, the test detects elevated levels of the nuclear matrix protein NMP22 and results are available during the patient visit.

Matritech is a Newton, Mass., developer of protein-based diagnostic products for the early detection of cancer.

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