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Journal of the American Medical Association Reports Matritech's NMP22 BladderChek Test Detects Bladder Cancers Missed By Cystoscopy

Posted on: Tuesday, 15 February 2005, 18:00 CST

BladderChek(R) Test Recommended As Adjunct to Cystoscopy in Diagnosing Bladder Cancer

The Point-of-Care Test Detected Three Times More Malignancies Than the Currently Used Laboratory Based Urine Cytology Test

According to a study published today in the Journal of the American Medical Association (JAMA), Matritech's (Amex:MZT) NMP22(R)BladderChek(R) Test detects cancers missed by cystoscopy, the medical reference standard used to diagnose bladder cancer. The NMP22(R)BladderChek(R) Test is the only FDA approved point-of-care, or in-office test, for the diagnosis of bladder cancer. The researchers concluded that the BladderChek(R) Test can increase the accuracy of cystoscopy in diagnosing bladder cancer, with results available during the patient's visit.

The authors, who include independent investigators at the University of Texas M.D. Anderson Cancer Center, the University of Rochester Medical Center, the University of Miami School of Medicine, and community based clinicians, reported that when used with cystoscopy, the NMP22(R)BladderChek(R) Test detected 94% of the bladder cancers, compared to 89% seen by cystoscopy alone. In addition to identifying four invasive, life threatening cancers missed during cystoscopic examination, the point-of-care test detected over 3 times as many malignancies as cytology, a laboratory based urine test. The study included 1,331 patients from 23 sites in 10 states.

The NMP22(R) BladderChek(R) Test was developed following the discovery by Matritech's scientists of a nuclear matrix protein, the NMP22(R) protein that is elevated in the urine of patients with bladder cancer. Matritech is a leading developer of protein-based diagnostic products for the early detection of cancer. Based on its proprietary nuclear matrix protein (NMP) technology, the Company's scientists discovered that the NMP22(R) marker proteins were elevated in the urine of patients with bladder cancer. NMPs are proteins associated with DNA replication and RNA synthesis and have been reported to be elevated or overexpressed in cancer cells. This discovery has led to the development and the FDA approval of the point-of-care NMP22(R) BladderChek(R) Test, which was evaluated by a team of independent urologists and clinicians; it is their findings that are reported in today's special biotechnology issue of JAMA.

The BladderChek(R) Test was also shown to be more effective than cystoscopy alone in detecting later stage bladder cancers. Of the total patients enrolled in the study, 79 had malignancies and 10 of those were muscle invasive. Initial cystoscopy visualized 60% of the invasive tumors, compared with the BladderChek(R) Test which was positive for 90% of the people with the life threatening condition. By comparison, cytology was positive for only 22% of the patients with muscle invasive cancer. The BladderChek(R) Test was also positive for a patient with carcinoma in situ (cancer that had not spread to surrounding tissues) after an initial cystoscopy report of benign disease.

"Early detection in cancer is the key to saving lives. We found that when cystoscopy and the NMP22(R) Test are used together, they detect bladder cancer at a 94% rate," stated the study's lead author and principal investigator, H. Barton Grossman, M.D., Deputy Chairman, Department of Urology, M.D. Anderson Cancer Center in Houston, TX. "In our study, the test identified several malignancies, including life threatening tumors, missed by the initial cystoscopy."

Also commenting on the study, Stephen D. Chubb, Chairman and CEO of Matritech said, "These results are an important validation of the clinical utility of the BladderChek(R) Test and our NMP technology. They also have important implications for medical practice; with the BladderChek(R) Test doctors can screen patients who are at elevated risk for bladder cancer with a non-invasive procedure. Diagnosing cancer early, when it is at its most curable stage, is the key to saving lives. Being able to treat cancer early improves the patient's prognosis and quality of life. Our goal is to provide clinicians and patients with an effective, convenient, rapid and low cost cancer diagnostic aid that can increase diagnostic accuracy and confidence." Mr. Chubb added, "And we are succeeding in achieving that goal. During 2004 an increasing number of urologists incorporated the NMP22(R)BladderChek(R) Test into routine use both here and in Europe. These physicians are using the BladderChek(R) Test for diagnosis as well as for monitoring patients with a history of bladder cancer. In the United States, where the BladderChek(R) Test is Medicare reimbursable, we are able to make it available at approximately half the cost of cytology."

About the Study

The blinded study was designed to evaluate the clinical utility of the NMP22(R)BladderChek(R) Test, a new point of care proteomic test, in enhancing the detection of bladder cancer. The performance of the NMP22(R)BladderChek(R) Test, that measures the NMP22(R) nuclear matrix protein in urine, was compared to voided urine cytology , which must be analyzed in a clinical laboratory, as an aid to cystoscopy in diagnosing bladder cancer.

About the NMP22(R) BladderChek(R) Test

The NMP22(R)BladderChek(R) Test is the only in-office test approved by the FDA for the diagnosis of bladder cancer. The NMP22(R)BladderChek(R) Test is a painless and non-invasive assay that detects elevated levels of the NMP22(R) protein on a single urine sample. Healthy individuals generally have very small amounts of NMP22(R) protein in the urine. The level of NMP22(R) protein, however, is often elevated in the urine of patients with bladder cancer, even at early stages of the disease. The BladderChek(R) Test, which has an average cost of about $30, is more cost effective than laboratory based cytology tests. It can be performed 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. The use of the NMP22(R) protein has been approved by the FDA four times for various formats and claims, most recently in April 2003 for point-of-care use for diagnosis.

About Cystoscopy

Cystoscopy is performed by the urologist. Local anesthesia is administered and a cystoscope (a telescope-like tube with a tiny camera attached) is inserted into the bladder through the urethra to allow the physician to detect abnormalities.

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 four to seven times more likely to get 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, the five-year bladder cancer survival rate is over 90%. 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 tumors will be diagnosed after they have become invasive or metastatic, significantly lowering the five year survival rate.

About Matritech

Matritech is using its patented nuclear matrix protein (NMP) technology to develop diagnostics for the detection of major cancers. The Company's first two products, the NMP22(R) Test Kit and NMP22(R)BladderChek(R) Test, have been approved for both the monitoring and diagnosis of bladder cancer. The NMP22(R) products are based on Matritech's proprietary NMP technology, exclusively licensed from the Massachusetts Institute of Technology, which correlates levels of NMPs in body fluids or cells to the presence of cancer. The Company has discovered other proteins associated with cervical, breast, prostate, and colon cancer and is, with its own research staff and through strategic alliances, in various stages of research and development currently targeted to applications for cervical, breast and prostate cancer. For more information about Matritech consult its web site at www.matritech.com.

Statement under the Private Securities Litigation Reform Act

Any forward-looking statements related to the Company's currently marketed products, their utility and market acceptance compared to other currently available technologies, as well as to the Company's present expectations about further development of products and technologies, are subject to a number of risks and uncertainties, many of which are beyond the Company's control. These include risks and uncertainties related to obtaining and maintaining regulatory approvals, market acceptance of and continuing demand for the Company's products, the impact of competitive products and pricing, technical challenges in completing product and technology development, and health care reform. These and other risk factors are described 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 update any such forward-looking information.

Source: Business Wire

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