My Bladder Cancer Fight

New Bladder Cancer, NMP22 BladderChek, Test Approved

Bladdercheck, a urine test has been approved by the FDA for the diagnosis of bladder cancer.

The NMP22 BladderChek Test is a painless and non-invasive test, performed on a single urine sample, that detects elevated levels of NMP22 protein.

Healthy individuals generally have very small amounts of NMP22 protein in the urine. However, the level of NMP22 protein is often elevated in the urine of patients with bladder cancer, even at early stages of the disease.

The test can be performed in a physician’s office with results delivered during the patient visit, allowing a rapid, accurate and cost-effective way to aid in the detection of bladder cancer in patients at risk.

Yair Lotan, M.D., Assistant Professor, Department of Urology, University of Texas Southwestern Medical Center, and his colleagues created a decision analysis model to assess cost-effectiveness and life years saved from screening versus not screening for bladder cancer in high risk populations. They found that the urine-based NMP22 BladderChek Test is cost effective for screening high risk populations based on its cost and accuracy in detecting bladder cancer.

“Cancer screening is generally considered a valuable tool for saving lives, but at this time it is limited to prostate, breast, colon, and cervical cancer. While the goal of cancer screening is to detect cancer early and save lives, it must be reasonably cost-effective if it is to be instituted widely,” said Dr. Lotan.

High risk was defined as over 50 years of age with a smoking history and/or significant occupational exposure to toxins or dyes. The authors also took into consideration factors that limit the effectiveness of cancer screening, including survival benefit, disease prevalence, screening efficacy and cost.

The NMP22 BladderChek Test is a point-of-care assay administered in the doctor’s office using four drops of urine with results available in 30 minutes. The test is marketed by Matritech (Amex: MZT), a leading developer and marketer of protein-based diagnostic products for the early detection of cancer.

Dr. Lotan suggests that bladder cancer is an ideal disease for screening a high risk population because the risk factors are well known. “The best possibility for reducing bladder cancer mortality is early detection,” he emphasized. “The initial diagnosis of one out of four bladder malignancies currently occurs when the cancer is at an advanced stage. Bladder tumors detected early, when they are non-muscle invasive, are very treatable and the five-year survival rate is 95%. However, once the tumors become more advanced the survival rate drops steadily from 50% to 10%.”

“This study goes beyond analyzing the cost per cancer detected. It is about the cost per life year saved and defines how effective a urine marker needs to be to perform as a screening tool. In the absence of screening, one in four bladder cancers is detected when it is already advanced, requiring expensive treatment and has reduced survival. Screening offers the potential for detecting cancers earlier, resulting in less extensive and less costly treatments, as well as improved survival,” Dr. Lotan explained.

There will be more than 63,000 new cases of bladder cancer in the U.S. this year and it is the 5th most common cancer among men and women. It is significantly more common and has a higher mortality than cervical cancer. It is almost as common in men as colon cancer. The prevalence of bladder cancer in the U.S. is higher than lung cancer and its prevalence in women is similar to ovarian cancer. Currently there are more than 500,000 Americans with a history of bladder cancer.

The Lotan analysis indicated urine-based bladder cancer markers could reduce mortality and save costs in a high-risk population, if the cost of the urine test is less than $126. Overall the Lotan model projected a gain of three life years and $101,000 saved from reduced treatment costs per 1,000 people screened based on a population with 4% incidence of bladder cancer. He noted that adjusting for other causes of mortality did not vary the results significantly, and screening versus not screening is more cost-effective as long as the cancer incidence is greater than 1.6%.

Nationally, bladder cancer has the highest cost per patient of the major cancers from diagnosis to death. This year alone in the U.S. it’s estimated that bladder cancer will cost $4 billion in direct costs.

“With the FDA approval of the NMP22 Test for detecting cancer in high risk patients, the healthcare community has a test that could be employed in screening,” commented Dr. Lotan.

The Full Article containing the above quotes.

Urine NMP22 Test (BladderChek) for Diagnosis of Bladder Cancer Approved in Japan

On July 14, the Japanese Ministry of Health, Labor, and Welfare approved a point-of-care proteomic test (BladderChek, made by Matritech Inc.) for use in conjunction with standard diagnostic procedures as an aid in the diagnosis and monitoring of bladder cancer.

The immunochromatographic assay detects levels of nuclear matrix protein 22 (NMP22) in urine, yielding results within the course of an office visit. Bladder cancer patients commonly have elevated urine levels of the protein compared with healthy individuals, even at early stages of the disease.

The approval was based on data from a large-scale multicenter clinical efficacy trial showing that the NMP22 assay detected bladder cancer with increased accuracy compared with urine cytology in 1,331 patients at increased risk of the disease based on hematuria (92%) and a history of smoking or irritative voiding symptoms. Both are adjunctive tests to cytoscopy in diagnosing bladder cancer.

Make sure that your Family Physician and or Urologist is aware of this new urine test for bladder cancer recurrence.

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