MZT,FDA approved in office Matritech's NMP22(R) BladderChek(R) Test Detects Bladder Cancers in Symptomatic Patients Missed by Traditional Laboratory Test
Thursday January 19, 11:40 am ET
Military Veterans with Blood in Their Urine Reported to Have Twice the Incidence of Bladder Cancer as Other Individuals
SAVANNAH, Ga.--(BUSINESS WIRE)--Jan. 19, 2006--Giora Katz, M.D., a urologist with the Lake City Veterans' Hospital in Lake City, Florida reported today that in a recent bladder cancer clinical trial including veterans hospitals, Matritech's (Amex: MZT - News) NMP22® BladderChek® Test detected three times more cases of bladder cancer in symptomatic patients than the traditional laboratory test, cytology. These results were from a new analysis of a large clinical trial published in the Journal of the American Medical Association (JAMA) in February, 2005. This week JAMA also reported that the point-of-care NMP22 BladderChek Test significantly increased the detection of recurrent bladder cancer, finding 99% of the malignancies when used with cystoscopy (a visual examination of the interior of the bladder).
Dr. Katz, a co-author on both JAMA studies evaluated the effectiveness of the BladderChek Test for diagnosis of bladder cancer in patients with hematuria (blood in the urine). He presented his findings today at the 53rd Annual James C. Kimbrough Urological Seminar in Savannah, Georgia, sponsored by the Uniformed Services University of the Health Sciences and the Society for Government Service Urologists.
The data presented by Dr. Katz showed the NMP22 BladderChek Test, which identifies a protein in the urine for bladder cancer, detected four life threatening cancers missed by cystoscopy, three invasive tumors and one non-invasive, but aggressive malignancy. When the BladderChek Test was combined with the diagnostic standard, cystoscopy, it significantly increased overall bladder cancer detection. The new data confirm similar findings of the test's effectiveness in detecting recurrent bladder cancer published in the January 18, 2006 issue of JAMA.
The two participating veterans' hospitals represented 9% of the sites in the study, but accounted for 16% of the cancers. That was because, although the patients at all sites presented with the same symptoms, such as hematuria, or painful or frequent urination, the percentage of those diagnosed with bladder cancer at the veterans' hospitals was 11.1%, compared to 5.7% at the community and academic practices. In addition, most of the malignancies at VA hospitals were already in an early invasive stage, compared to the other sites where the most common stage was noninvasive.
Dr. Katz commented, "The VA is the largest provider of health care in the country, and it provides excellent medical care to those who have served this country. It is not a surprise that the bladder cancer rate is high here. The American Cancer Society statistics show that bladder cancer occurs most commonly in men over the age of 60, and they make up a large proportion of our patient population. Moreover, smoking and occupational or environmental exposure to chemicals substantially increase the risk of urological malignancy, and many of our patients have these risk factors. We need to educate our patients and use the best tools we have to diagnose them early. The NMP22® BladderChek® Test is noninvasive, provides a result while my patient is in the office, is proven to improve detection of cancer, and is half the cost of laboratory tests. Considering the limited resources for healthcare in the VA and everywhere else, using the BladderChek Test will help identify those who need more urgent evaluation within a shorter period of time than others."
About Bladder Cancer
Bladder cancer is the fifth most common malignancy in the United States. There are over 500,000 people in the U.S. who have had bladder cancer, making it more prevalent in the population than lung and bronchial cancers. The American Cancer Society estimates that over 63,000 new cases of bladder cancer were diagnosed in the United States in 2005 (over 47,000 men and 16,000 women), and over 13,000 people died 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. The most common symptom of bladder cancer is blood in the urine, a condition referred to as hematuria.
Bladder cancer is diagnosed primarily in men age 60 and older (it does occur at younger ages) and roughly twice as frequently in white men as in black men. Men are three times more likely to be diagnosed with bladder cancer than women, but a greater percentage of women are diagnosed at an invasive stage of the malignancy. 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 more than 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.
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 94%. 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.
Among U.S. women, according to the most recent SEER data, the prevalence of bladder cancer (140,000) is similar to the number of women with cervical (184,000) and ovarian (159,000) cancers. The five year survival rate of women is less than the ten year survival rate of men. Diagnosis in women may be delayed because symptoms are misinterpreted or attributed to other causes. This delay is correlated with a disproportionately higher death rate among women. In 2005 women accounted for one in four new bladder cancer diagnoses, but one in three bladder cancer deaths.
About the Study
The study included 1,331 patients from 23 sites in 10 states and included private practice, academic centers and VA hospitals. All patients were being evaluated for bladder cancer due to symptoms or risk factors. Of the total study population, 1,220 patients (91.7%) presented with hematuria. The study was designed to evaluate the clinical utility of the NMP22® BladderChek® Test, a point-of-care proteomic test, in enhancing the detection of bladder cancer. The performance of the NMP22 BladderChek Test, which measures the NMP22 nuclear matrix protein in urine, was compared to voided urine cytology, which must be analyzed in a clinical laboratory, and as an aid to cystoscopy in diagnosing bladder cancer among patients with hematuria.
About the NMP22® BladderChek® Test
The NMP22® BladderChek® Test was developed and is commercialized by Matritech (Amex: MZT - News), a leading developer of protein-based diagnostic products for the early detection of cancer. The NMP22 BladderChek Test detects elevated levels of the NMP22 protein in a single urine sample. Most healthy individuals have very small amounts of the NMP22 protein in their urine, but bladder cancer patients commonly have elevated NMP22 protein levels, 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 and other medical insurers, 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.
In May, 2005 the NMP22 BladderChek Test was featured in a number of platform presentations at the 100th annual meeting of the American Urological Association (AUA); these included clinical trial results and a cost impact analysis that demonstrated the costs of detecting a case of bladder cancer using the BladderChek Test are similar or less than currently accepted cancer screening methods such as mammography, PSA, and colonoscopy. Additionally, the NMP22 BladderChek Test was part of the curriculum in an AUA sponsored CME course on bladder cancer based on information presented at the annual meeting.
About Matritech
Matritech (Amex: MZT - News) 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® Test Kit and NMP22® BladderChek® 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. Beginning with a patent portfolio licensed exclusively from the Massachusetts Institute of Technology (MIT), Matritech's patent portfolio has grown to 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
bladder cancer test.............
