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American Cancer Society Journal Article Reports Screening High Risk Populations for Bladder Cancer is Cost Effective

Posted on: Monday, 24 July 2006, 09:00 CDT

An article published in an early online view of the American Cancer Society's journal Cancer reports that screening for bladder cancer in high risk populations can save lives and reduce overall medical expenses. All other cancer screening programs save lives but increase expenses. Screening for bladder cancer with the NMP22(R) BladderChek(R) Test was less costly than not screening. The article will appear in the September 1 print issue of the journal.

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.

In the article, the authors pointed out that another advantage for bladder cancer screening is the low cost of the NMP22 BladderChek test, so those patients without cancer do not have a high cost burden compared to cancer screening using colonoscopy or mammography.

Another recent study has proven that screening reduced bladder cancer mortality. Results of the long-term study were reported at the 2006 annual meeting of the American Urological Society (AUA) meeting by Edward Messing, M. D., Chairman of the Urology Department, University of Rochester Medical Center. His 14-year follow up of patients screened for bladder cancer showed that no patients who underwent screening died from bladder tumors, whereas 20% of unscreened patients did die from bladder cancer. The tumors found by screening were diagnosed at earlier stages, thereby improving outcomes. Overall mortality was significantly lower in screened patients (43%) compared to those whose were not screened (74 %). Dr. Messing is also a co-author of the two studies on the NMP22 BladderChek Test published in JAMA.

Implementation of a screening strategy requires a prospective, randomized trial to assess both the detection accuracy in asymptomatic individuals and the impact of screening on cancer-specific mortality. Dr. Lotan has initiated such a screening clinical trial, and he believes that in the meantime, this model will help healthcare professionals identify at risk populations that would benefit from bladder cancer screening.

About the NMP22(R) BladderChek(R) Test

The NMP22(R) BladderChek(R) Test was developed and commercialized by Matritech, a leading developer and marketer of protein-based diagnostic products for the early detection of cancer. The NMP22 BladderChek 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 levels, even at early stages of the disease.

The NMP22(R) BladderChek(R) Test, a painless and noninvasive assay, 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 NMP22 BladderChek Test is reimbursed by Medicare and many medical insurers and has an average cost of less than $30. It also has been shown to detect over three times as many cancers as the commonly used laboratory based urine cytology test.

Two studies published in the Journal of the American Medical Association (JAMA) in February 2005 and January 2006 reported on clinical data showing the NMP22 BladderChek Test, used in combination with cystoscopy (a visual examination of the interior of the bladder using a scope inserted through the urethra), for the diagnosis and monitoring of bladder cancer detected up to 99% of bladder malignancies. The NMP22 BladderChek 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 was also 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.

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. 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.

Statement under the Private Securities Litigation Reform Act

Any forward-looking statements relate to the Company's current expectations of the Company's NMP22(R) 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 including those 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 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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