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AusAm's Accumin Urine Test for Indicator of Potential Kidney Disease Offered by Specialty Laboratories.


NEW YORK -- Proprietary Test Can Detect Microalbuminuria microalbuminuria /mi·cro·al·bu·min·uria/ (-al-bu-min-u´re-ah) a very small increase in urinary albumin. Up To 12 Years Earlier In Patients At-Risk For Developing Kidney Disease

AusAm Biotechnologies, Inc. today announced that Specialty will now offer AusAm's FDA-cleared diagnostic, Accumin(TM) Direct Total Intact Albumin Assay (HPLC)(TM) for detection of the protein albumin in urine. Accumin screens for abnormal levels of albumin in urine, a condition known as microalbuminuria, which could be an early sign of kidney disease. The American Diabetes Association recommends annual microalbumin tests for patients, such as diabetics, who are at risk of developing kidney disease.

Diabetes and high blood pressure are the leading causes of kidney failure. Individuals with a family history of kidney failure are also at risk. Clinical studies show that if detected in its early stages, severe kidney disease can be slowed, halted and in some cases reversed with common drug therapies such as angiotensin angiotensin /an·gio·ten·sin/ (-ten´sin) a decapeptide hormone (a. I) formed from the plasma glycoprotein angiotensinogen by renin secreted by the juxtaglomerular apparatus. It is in turn hydrolyzed by a peptidase in the lungs to form an octapeptide (a. II), which is a powerful vasopressor and stimulator of aldosterone secretion by the adrenal cortex. This is in turn hydrolyzed to form a heptapeptide (a. converting enzyme (ACE) inhibitors and angiotensin-2 receptor blockers (ARBs).

"We believe the Accumin assay has very important clinical utility," said Ronald A. Blum, Ph.D., director of medical communications at Specialty Laboratories. "Its main advantage over traditional diagnostics is the early identification of kidney disease. This benefit is important for the health of the diabetic patient, allowing doctors to begin treatment in the early stages of disease and hopefully prevent complications. The Accumin assay also makes sense from a cost-benefit perspective. We believe this test may help reduce the need for more extensive and expensive medical testing and procedures. Specialty is very excited to be working with AusAm to deliver this innovative assay."

Accumin provides the first and only direct, quantitative measurement for urinary albumin. The direct method detects albumin and permits measurement of intact albumin not identified by current antibody and dye-binding tests. With Accumin, the potential for false negative results is reduced as compared to conventional commercial assays that fail to detect all intact albumin in the urine.

"As one of the largest hospital-focused clinical labs in the country, Specialty maintains strong working relationships with a large number of physicians. This gives us access to a broader physician pool to effectively diagnose microalbuminuria," said James R. McCullough, chief executive officer of AusAm Biotechnologies. "Our goal is to make Accumin the standard of care for patients across the country, and we are pleased that Specialty is joining us in this effort."

About Accumin(TM) Direct Total Intact Albumin Assay (HPLC)(TM)

Cleared by the U.S. Food and Drug Administration in August 2003, Accumin was developed by AusAm Biotechnologies as a step-change improvement over conventional tests for microalbuminuria. Accumin uses common laboratory equipment to separate intact albumin from the other compounds in urine and directly determine its quantity. Accumin is relatively inexpensive and is reimbursable by Medicare where medically reasonable and necessary. Patients who are interested in more information should consult their physicians about Accumin, or go to www.ausambiotech.com. Physicians interested in ordering this test should contact Specialty Laboratories at 800-421-7110 or visit their Web site at www.specialtylabs.com.

About AusAm Biotechnologies, Inc.

AusAm is a biotechnology research and development company commercializing both diagnostic and therapeutic products to identify and treat major diseases. Accumin(TM), AusAm's recently FDA-cleared diagnostic for the detection of intact albumin in urine, is the first direct test to measure a potential indicator of the beginning stages of kidney disease and it is currently offered by several reference laboratories and hospitals in the United States. For additional information, please contact AusAm at 212-659-0703 or email inquiries to info@ausambiotech.com.

Safe Harbor Statement

This press release contains forward-looking statements with respect to management's beliefs about the business of AusAm in the future. These forward-looking statements involve a number of risks, uncertainties and other factors that could cause actual results to differ materially from those suggested by the forward-looking statements. These risks and uncertainties include, but are not limited to the ability of AusAm to successfully implement the strategy of AusAm. AusAm undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unexpected results.
COPYRIGHT 2004 Business Wire
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Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Sep 29, 2004
Words:679
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