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Revolutionary new test for bladder cancer receives FDA clearance.


NEW ORLEANS--(BW HealthWire)--April 15, 1997--

- The BTA (Business Technology Association, Kansas City, MO, www.bta.org). A membership association of manufacturers, dealers, distributors and service companies in the business equipment and systems industries, founded in 1994.  stat test provides smokers and other high-risk groups

with a powerful management tool in the fight against the disease -

Today patients were armed in the battle against bladder cancer bladder cancer

Malignant tumour of the bladder. The most significant risk factor associated with bladder cancer is smoking. Exposure to chemicals called arylamines, which are used in the leather, rubber, printing, and textiles industries, is another risk factor.
 with the simplest, non-invasive test for the life-threatening disease.

Using the same technology commonly seen in one-step pregnancy tests, the new BTA stat test can be performed in a doctor's office, providing physicians and their patients with accurate information in minutes. Developed by Bard Diagnostic Sciences, a division of C.R. Bard (NYSE NYSE

See: New York Stock Exchange
: BCR BCR B Cell Receptor
BCR Business Communications Review (magazine)
BCR Banca Comerciala Romana (Romanian bank)
BCR Breakpoint Cluster Region
BCR Benefit/Cost Ratio
BCR Bay City Rollers
), BTA stat is expected to significantly improve the management of bladder cancer patients.

The new test could be a life-saver for the 48 million smokers across the country who are at greatest risk for bladder cancer -- experiencing twice the risk of nonsmokers. In fact, smoking is estimated to be responsible for approximately 47 percent of the bladder cancer deaths among men and 37 percent among women, according to the American Cancer Society American Cancer Society,
n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research,
.

Between 50 percent and 80 percent of all patients diagnosed with superficial bladder cancer will have a recurrence of the disease, so lifelong monitoring of all bladder cancer patients is essential.

When detected early, bladder cancer is one of the most highly curable cur·a·ble
adj.
Capable of being cured or healed.
 types of cancer. The five-year survival five-year survival Epidemiology The timespan that a person survives with a particular dread disease, in particular CA; 5YS facilitates standardization of survival statistics. See Cancer-free survival.  rate for bladder cancer that is diagnosed at an early stage is 93 percent. When caught late, however, the survival rate plummets to just six percent, according to the American Cancer Society.

Bladder cancer is one of the most common types of cancer in the United States and abroad. Bladder cancer strikes almost 53,000 Americans each year, and more than 250,000 people are routinely monitored for the disease, according to the American Cancer Society. The cancer strikes most often among people over the age of 50, smokers and workers exposed to chemicals in the rubber, leather tanning, metal and dye industries.

The BTA stat test is a rapid, cost-effective test that allows physicians to make immediate decisions about diagnostic management, specialist referrals and future patient care. It is non-invasive, simple to perform using a patient's urine sample and provides easy-to-interpret results within minutes.

The BTA stat test represents a new generation of innovative, cost-effective tests for bladder cancer management developed by Bard Diagnostic Sciences. The company's first bladder cancer management tool, the Bard(R) BTA(R) Test, received market approval from the Food and Drug Administration in late 1995. The new, rapid BTA stat test is even simpler to perform and improves upon the original Bard BTA Test. The new test is an immunoassay Immunoassay

An assay that quantifies antigen or antibody by immunochemical means. The antigen can be a relatively simple substance such as a drug, or a complex one such as a protein or a virus.
 that uses monoclonal antibodies to detect the presence of bladder tumor associated antigen in urine. Neither calibration nor instrumentation is necessary. The BTA stat test has a built-in procedural control line which verifies that the test has been performed correctly. The test can be used as a cost-effective adjunct or alternative to cytology cytology (sītŏl`əjē), in biology, the study of the structure of all normal and abnormal components of cells and the changes, movements, and transformations of such components. .

Until the advent of the Bard tests, urine cytology was the only in vitro testing tool available with respect to bladder cancer. Cytology requires interpretation by cytologist cy·tol·o·gist
n.
A specialist in cytology.



cytologist

a specialist in cytology.
 or pathologist and is generally considered to have poor sensitivity, particularly for low-grade bladder tumors. By comparison, the BTA stat test uses a proven technology which requires no interpretation and, in a recent clinical study, was shown to be significantly more sensitive than cytology across all tumor grades.

The Bard BTA stat test recently received FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approval and will be distributed to U.S. physicians through Bard Urological Division and Physicians Sales and Service (PSS See EPSS. ). Curtin Matheson Scientific will distribute the BTA stat test to laboratories.

Bard Diagnostic Sciences, based in Redmond, Wash., specializes in developing innovative and cost-effective cancer-detection tests. Formerly Bainbridge Sciences, Bard Diagnostic Sciences was acquired in 1993 by New Jersey-based C.R. Bard (BCR), a leading international developer, manufacturer and supplier of life-saving products and services for the urology, cardiovascular and surgical markets. For more information about Bard Diagnostic Sciences, BTA stat and the company's other testing tools, please visit our Web site at www.barddiagnostics.com .

CONTACT: Bard Diagnostic Sciences

Steve Van Leeuwen/Dino Alfano, 206/814-1606

or

MWW/Savitt

Anne Walker/Shannon Lawrence, 206/689-8505
COPYRIGHT 1997 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1997, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Apr 15, 1997
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