A Diagnostics & Imaging Week

ATLANTA – A new analysis has demonstrated that the Matritech (Newton, Massachusetts) NMP22 BladderChek test, combined with cystoscopy, a visual examination of the bladder with a lighted scope, provides information about the stage and grade of a bladder cancer prior to a biopsy, the company said.

The analysis was presented at the recent annual meeting of the American Urological Association (AUA; Linthicum, Maryland) by Mark Soloway, MD, chairman of the department of urology at the University of Miami Leonard M. Miller School of Medicine.

Matritech said that the NMP22 BladderChek test is the "only urine test shown to indicate whether a bladder malignancy is likely to be dangerous – muscle invasive and/or aggressive – or confined to the bladder and slower growing, thus providing doctors with essential information to determine the best course of treatment."

Soloway commented: "Using the NMP22 BladderChek test with cystoscopy adds useful information to enhance our ability to detect and treat a cancer. Cystoscopy is very good, but not perfect – that's why physicians use adjunctive tests."

The test detects elevated levels of the NMP22 protein marker in a single urine sample. Most healthy individuals have very small amounts of the NMP22 protein marker in their urine, but bladder cancer patients commonly have elevated NMP22 protein marker levels, even at early stages of the disease.

The new analysis demonstrated that when a tumor was seen during cystoscopy and the NMP22 BladderChek test result was positive, the cancer was almost three times as likely to have progressed into muscle and/or be high grade – that is, aggressive.

Conversely, when a tumor was visible during cystoscopy but the result of the test was negative, the cancer had a greater likelihood of being confined to the bladder lining and less aggressive. This was true for both newly diagnosed and recurrent cancers.

A new diagnostic algorithm illustrating the integration of the NMP22 BladderChek test into standard practice was discussed by Soloway.

Co-authors on the poster titled, "Evaluation of Risk for Muscle Invasive and High Grade Bladder Cancer Using a Point-Of-Care Assay" in which the algorithm was illustrated include Barry Stein, MD, surgeon-in-chief of urology, Rhode Island Hospital and professor of urology, Brown Medical School (Providence, Rhode Island) and Yitzhak Berger, MD, of Associates in Urology (West Orange, New Jersey).

Soloway explained that two studies published in the Journal of the American Medical Association in January 2006 and February 2005, on which he was a co-author, showed that the test identified cancers not seen during cystoscopy, either because they were outside the viewing field of the cystoscope or because they were difficult to differentiate from normal tissue.

In fact, the clinical data showed that the NMP22 BladderChek test, used in combination with cystoscopy in the diagnosing and monitoring of bladder cancer detected up to 99% of bladder malignancies.

The test also detected cancers that were missed during an initial cystoscopic examination, most of which were high grade. In other clinical study analyses it was shown to detect 100% of the aggressive tumors, one of which was muscle invasive, in women with symptoms or risk factors for bladder cancer.

It also was reported to detect all of the cancers that occurred in the upper urinary tract of patients with risk factors or symptoms of bladder cancer. Cystoscopy did not identify these tumors because they were outside the viewing area of the instrument.

Stein said, "If cystoscopy is negative but the NMP22 BladderChek test is positive, doctors should consider the possibility of an upper tract or occult cancer. These newest analyses show that the NMP22 test also provides clinically useful information when cystoscopy is positive. No other test has done that. Knowing the relative risk that a cancer is advanced and/or aggressive or earlier stage can help in patient management."

Twenty-five percent of primary bladder cancers are invasive at first diagnosis, and one-third are high grade. Among patients with a history of bladder cancer, 50% or more have recurrences, and progression of stage or grade occurs in 10%-50%. In patients with muscle invasive disease, a delay in surgery is associated with a more advanced pathological state and poorer prognosis, Matritech said.

If detected early, bladder cancer is highly curable, with 94% 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, the company said.

"Until now, there has not been a simple in-office test to reliably diagnose this disease," said. Soloway. "It's important because too often we see men and women who have blood in the urine or symptoms that could be bladder cancer, but are treated for suspected [urinary tract] infections for several months before they're diagnosed. Unfortunately, those months can make a significant difference in the ability to cure those cancers."

He concluded, "The NMP22 test will also be a critical tool for regularly evaluating patients at high risk for bladder cancer: long-time smokers, people who work around particulates in manufacturing, or who work with chemicals like those in hair dyes, as well as, firefighters. I had a gentleman patient who had no symptoms but he was a cigarette smoker. He was feeling fine, but he had a bulky tumor. And now despite major surgery he may not be cured, so we need some kind of test like this."

The company said that NMP22 BladderChek test is the only in-office test approved by the FDA for both the diagnosis and monitoring of bladder cancer. It is used in a physician's office, requires only four drops of urine and results are available in 30 minutes - during the patient visit, allowing a rapid, and accurate way to aid in the detection of bladder cancer.

The test is reimbursed by Medicare and other medical insurers and has an average cost of less than $30, the company said. Matritech also said that the test "has been shown to detect over three times as many cancers as the commonly used laboratory based urine cytology test."

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