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Study Suggests Accumin -Formerly Microalbumin Plus- Methodology May Become Global Diagnostic Standard to Detect Early Sign of Kidney Disease.

Business Editors/Health/Medical Writers

SANTA MONICA, Calif.--(BUSINESS WIRE)--March 23, 2004

Study Shows Variation between Conventional Urine Testing and

Accumin for Measuring Urine Protein Albumin

A research study published in the February issue of Clinical Biochemistry suggests a need to establish a global standard for how urinary albumin is measured. The study examined four immunoassays and high performance liquid chromatography (HPLC), the method used by the FDA-cleared Accumin(TM) Direct Total Intact Albumin Assay (HPLC)(TM). The results found variations in each methodology examined. The authors suggest that the Accumin HPLC method may provide a global standard, citing previous research indicating HPLC detects microalbuminuria in urine earlier than other commonly used albumin assays.

Above normal levels of intact albumin in urine, a condition known as microalbuminuria, is the earliest sign of potential kidney disease. Urinary albumin analysis is routinely part of annual patient diabetic screenings, and is one of the most widely measured diagnostic markers in the world. The researchers note that the Accumin HPLC analysis of urinary albumin is well defined, since it is able to detect both intact immunoreactive albumin as well as previously undetected intact immuno-unreactive albumin.

The study, "Differences in Urinary Albumin Detected by Four Immunoassays and High-Performance Liquid Chromatography," was conducted at Monash University and the Austin & Repatriation Medical Centre, University of Melbourne. In it, researchers compared the analysis of urinary albumin from diabetic patients using five assays: radioimmunoassay (RIA); immunoephelometry (IN); two different methods of immunoturbidimetry (IR) and the HPLC method.

"Routine screening to detect microalbuminuria is crucial to patient care, particularly in diabetic patients," said Dr. Wayne Comper, the study's lead investigator, and Chief Science Officer at AusAm Biotechnologies, Inc. and Reader in Biochemistry at Monash University in Australia. "Early detection and treatment may help slow or even prevent progression to persistent albuminuria and end-stage renal failure. Research indicates that the Accumin HPLC methodology detects microalbuminuria earlier than other urinary albumin testing methods. Therefore, Accumin could become the gold standard for physicians trying to identify patients at risk for kidney disease and other clinical manifestations of kidney disease."

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.

Availability of Accumin(TM) Direct Total Intact Albumin Assay (HPLC)(TM)

The Accumin test is performed on a urine sample in a hospital or reference laboratory. 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

About AusAm Biotechnologies, Inc.

AusAm is a biotechnology research and development company commercializing both diagnostic and therapeutic products to identify and treat major diseases. AusAm's recently FDA-cleared diagnostic for the detection of intact albumin in urine, Accumin, is the first direct test to measure a potential indicator of the beginning stages of kidney disease. AusAm's diagnostic 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

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.
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Publication:Business Wire
Geographic Code:1USA
Date:Mar 23, 2004
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