JAMA Reports that the NMP22(R) BladderChek(R) Test is Better at Detecting Bladder Malignancies than Current Technologies

A simple point-of-care urine test, the NMP22 BladderChek Test, was found to significantly increase the detection of recurrent bladder cancer, finding 99% of the malignancies when used with cystoscopy, according to a report in the January 18 issue of the Journal of the American Medical Association (JAMA).

The lead author, H. Barton Grossman M.D. at the M. D. Anderson Cancer Center stated, "This study confirms the prior BladderChek investigation published in JAMA early last year-- NMP22 BladderChek combined with cystoscopy detects significantly more cancers than cystoscopy alone.

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."

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. The BladderChek test was positive for 8 of 9 cancers not seen by cystoscopy, including seven tumors that were aggressive or advanced.

The BladderChek test also detected four times as many cancers as the commonly used laboratory based urine cytology test. The authors of the study, who include clinical investigators at the University of Texas M. D. Anderson Cancer Center, the University of Miami School of Medicine, the University of Rochester Medical Center, Rhode Island Hospital, and community based clinicians, recommended using the NMP22 BladderChek(R) Test in the routine monitoring and management of bladder cancer patients.

They 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. When combined with cystoscopy the NMP22(R) test improves the detection of cancer. Unlike all cell-based urine tests it does not require laboratory time and facilities and expert analysis. This point-of-care test provides unambiguous results during a patient's visit.

"NMP22(R) BladderChek(R) Test is an important tool for doctors--early detection of bladder cancers, both initial and recurrent, improves treatment options and patient outcome," said Edward Messing M. D., Chairman of the Urology Department at the University of Rochester Medical Center. "Delay of diagnosis of an aggressive bladder cancer even by a few months can affect prognosis. The AUA guidelines for evaluation of patients with blood in the urine recommend using a urine test as back up to cystoscopy. We use the NMP22 test in our practice, and will include it in an upcoming National Cancer Institute (NCI) study for monitoring bladder cancer recurrence after treatment."

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. The prevalence of bladder cancer in the United States is higher than lung cancer; and its prevalence in women is similar to the number of women with cervical and ovarian cancers. Currently there are 500,000 Americans with a history of bladder cancer. Developed and commercialized by Matritech (Amex: MZT), a leading developer of protein-based diagnostic products for the early detection of cancer, 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.

"Bladder cancer is the second most common urologic malignancy in the U.S. after prostate cancer," notes investigator and author Mark Soloway M.D., Chairman, Department of Urology at the University of Miami School of Medicine. "We have made dramatic changes with the use of PSA, an early detection program, and tremendous public awareness. Unfortunately, we have not done the same with bladder cancer. o­ne quarter of all bladder malignancies are still first diagnosed after they have become invasive, so treatment is more difficult and prognosis is worse. This hasn't changed in 20 years. The NMP22 BladderChek test is an important step forward. Not o­nly has it been demonstrated in two large studies to improve detection of new and recurrent cancers, it provides an easy and inexpensive way for primary care doctors to screen patients we know are at higher risk for bladder cancer: people who smoke, are exposed to chemicals or have blood in their urine."

Because of the high recurrence rate of bladder cancer, patients who have had the disease are typically evaluated for new tumors every three months for the first two years after surgery, twice a year for the next two years, and yearly after that, until a recurrence is diagnosed, at which point monitoring resumes at three month intervals. Early detection is key to extending and providing quality of life for patients, and reducing treatment costs. The five year survival rate is 94% for patients diagnosed with early stage, or noninvasive cancer, while patients with metastatic or advanced stages of the disease have as low as a 6% chance of surviving five years.