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Matritech's NMP22 BladderChek Test Reported to Be Cost Effective in Detecting Bladder Cancer

Posted on: Wednesday, 25 May 2005, 09:00 CDT

Prior to the Availability of the NMP22 BladderChek Test, Bladder Cancer Screening Approached Being Cost Prohibitive

Clinicians from the University of Texas Southwestern Medical Center presented new data at the annual meeting of the Society of Urologic Oncology about the cost effectiveness of screening for bladder cancer using the NMP22(R) BladderChek(R) Test, an FDA approved point-of-care urine based test. The data showed the BladderChek Test to be half the cost of traditional bladder cancer screening methods, bringing the cost effectiveness in line with currently accepted cancer screening tests. Costs of detecting a case of bladder cancer using the BladderChek Test are similar to mammography, PSA, and colonoscopy. Bladder cancer has the highest cost per patient of all cancers from diagnosis to death and is almost as common in men as colon cancer. In the United States alone, it is estimated that the annual direct costs of bladder cancer management are $4 billion.

Commercialized by Matritech (Amex: MZT) a leading developer of protein-based diagnostic products for the early detection of cancer, the NMP22 BladderChek Test was one of several biomarker tests evaluated by Yair Lotan, M.D., Assistant Professor, Department of Urology, University of Texas Southwestern Medical Center and his colleagues. Their study, The Cost Effectiveness/Efficacy Algorithm Concerning Molecular Diagnosis of Bladder Carcinoma: With or without Cystoscopy, utilized a decision analysis model based on national statistics and a recent study of high-risk patients, to evaluate the cost of screening individuals at high risk (based on risk factors such as long-term smoking or exposure to chemicals and dyes) with bladder tumor markers. Dr. Lotan reported on the results of the study in a podium presentation at the Society's annual meeting.

Dr. Lotan concluded that the NMP22 BladderChek Test is expensive compared to other biomarker tests and has improved sensitivity compared to the currently used urine cytology test. The point-of-care test is also reimbursed by Medicare in 49 states for diagnosing and monitoring of bladder cancer. "If the NMP22 BladderChek Test were to be used for screening very high-risk adults, this test would be comparable and within cost parameters of other cancer screening tests," he said.

Using Dr. Lotan's bladder cancer model, the NMP22 BladderChek point-of-care test yields a cost-per-cancer detected of $2,625, assuming a cancer incidence of about 8% per year. Dr. Lotan and his colleagues found this cost comparable to accepted cancer screening tests such as mammography, PSA, and colonoscopy. For women undergoing mammography screening, the cost per breast cancer detected can be as high as $14,000. Prostate cancer screening with PSA leads to costs of nearly $3,000 per cancer detected; colorectal cancer screening has a broader range of $2,000-$5,000 per cancer detected.

The NMP22 BladderChek Test is the only in-office test approved by the FDA for the diagnosis of bladder cancer. It is a painless and non-invasive assay that detects elevated levels of the NMP22 protein -in a single urine sample. Performed in the doctor's office, results are available during the patient's visit.

The goal of cancer screening is to detect cancer early. One in four bladder malignancies is currently diagnosed at an advanced stage. Bladder tumors detected at an early stage are often treatable, and the five-year survival rate is 95%. However, once the tumors become more advanced the survival rate drops steadily to 10%.

In presenting his research, Dr. Lotan asked the question, "Can we afford bladder cancer screening?" He explained, "If the universe of patients is screened, the cost per cancer is in the hundreds of thousands of dollars. Yet, screening very high-risk groups based on risk factors such as smoking or environmental exposure to carcinogens may yield a cost that is reasonable, with less morbidity to the patient and with a reduction in cancer deaths."

Beyond the cost per cancer for screening, other research has shown the direct cost of treatment for patients with metastatic bladder cancer can be more than 6 times greater than for those patients with localized disease. Accordingly, the challenge is to improve detection, without increasing risk or discomfort to the patient.

Dr. Lotan concluded that integrating bladder cancer screening into diagnostic guidelines has broad implications on cost, morbidity and psychological factors. And while he recommends additional studies to compare survival with and without a screening strategy for bladder cancer, he added, "Biomarker tests may have a role in screening high risk groups of men and women."

About the NMP22(R) BladderChek(R) Test

The NMP22 BladderChek Test was developed and commercialized by Matritech, a Massachusetts-based biotech company.

The NMP22 BladderChek Test detects elevated levels of the NMP22 protein in a single urine sample. Healthy individuals generally have very small amounts of NMP22 protein in their urine. NMP22 protein levels, however, are often elevated in the urine of patients with bladder cancer, even at early stages of the disease.

The NMP22 BladderChek Test, a painless and non-invasive assay, is the only in-office test approved by the FDA for the diagnosis of bladder cancer. The BladderChek Test, which is reimbursed by Medicare at about $24, is more cost effective than cell-based laboratory cytology tests. It is approved for use in a physician's office with results available during the patient visit, allowing a rapid, accurate and cost-effective way to aid in the detection of bladder cancer. NMP22 Tests have been approved by the FDA four times for two formats and claims, most recently in April 2003 for point-of-care use for diagnosis.

About Bladder Cancer

Bladder Cancer is the fifth most common form of cancer in the United States and the ninth most common form of cancer in the world today. The American Cancer Society estimates that over 63,000 new cases of bladder cancer will be diagnosed in the United States this year (over 47,000 men and 16,000 women), and over 13,000 people will die of the disease (nearly 9,000 men and 4,000 women). Worldwide it accounts for 330,000 new cases and 100,000 deaths each year. It is also one of the most chronic cancers, recurring in almost 70% of patients.

Bladder cancer occurs primarily in men age 60 and older and roughly twice as frequently in white men as in black men. Men are four times more likely to be diagnosed with bladder cancer than women; age-adjusted mortality rates from bladder cancer are similarly higher for men than for women. Among U.S. males, the incidence of new bladder cancer cases is almost as large as the incidence of colon cancer.

The most common risk factor for bladder cancer is smoking. Smokers are twice as likely to develop bladder cancer as nonsmokers. In the United States, smoking is estimated to be associated with about 50% of bladder cancer deaths among men and 30% among women. The most common symptom of bladder cancer is blood in the urine, a condition referred to as hematuria.

Occupational exposures to chemicals (aromatic amines) used in dry cleaning facilities and the production of dyes, paper, rope, apparel, rubber and petroleum products have been associated with increased risk for bladder cancer. Other industrial exposures implicated as risk factors for developing bladder cancer include combustion gases and soot from coal, chlorinated aliphatic hydrocarbons, and chlorination by-products in heated water.

If diagnosed in its early stages, bladder cancer has a five-year survival rate of 95%. If diagnosed at an advanced stage, however, the five-year survival rate can be less than 10%. It has been estimated that this year in the United States about 25% of bladder cancer patients will be diagnosed after their disease has become invasive or metastatic, significantly lowering the five year survival rate.

About Matritech

Matritech is using its patented proteomics technology to develop diagnostics for the detection of a variety of cancers. The Company's first two products, the NMP22(R) Test Kit and NMP22(R) BladderChek(R) Test, have been FDA approved for the monitoring and diagnosis of bladder cancer. The NMP22 BladderChek Test is based on Matritech's proprietary nuclear matrix protein (NMP) technology, which correlates levels of NMPs in body fluids to the presence of cancer. Matritech's patent portfolio includes three patents exclusively licensed from the Massachusetts Institute of Technology and more than 15 other U.S. patents. In addition to the NMP22 protein marker utilized in the NMP22 Test Kit and NMP22 BladderChek Test, the Company has discovered other proteins associated with cervical, breast, prostate, and colon cancer. The Company's goal is to utilize these protein markers to develop, through its own research staff and through strategic alliances, clinical applications to detect cancer. More information about Matritech is available at www.matritech.com.

Statement under the Private Securities Litigation Reform Act

Any forward-looking statements relate to the Company's current expectations of the Company's products and technology. Actual results may differ materially from those predicted in such forward-looking statements due to the risks and uncertainties inherent in the Company's business, including without limitation risks and uncertainties in obtaining and maintaining regulatory approval, market acceptance of and continuing demand for the Company's products, the impact of competitive products and pricing, and technical challenges in completing product and technology development. Please refer to the risk factors detailed in the Company's periodic reports and registration statements as filed with the Securities and Exchange Commission. These forward-looking statements are neither promises nor guarantees. There can be no assurance that the Company's expectations for its products or future financial performance will be achieved. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Matritech undertakes no responsibility to revise or update any such forward-looking information.

Source: Business Wire

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