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Millennium Diagnostics Joins Growing Ranks of ``Centers of Excellence'' Offering AusAm's Urine Test for Indicator of Potential Kidney Disease.

Business Editors/Health/Medical Writers


AusAm's Accumin(TM) Provides the First Direct Measurement

of Total Intact Protein Albumin in Urine

AusAm Biotechnologies, Inc. today announced that Millennium Diagnostics now offers AusAm's FDA-cleared diagnostic, Accumin(TM) Direct Total Intact Albumin Assay (HPLC)(TM) for detection of the protein albumin in urine. An excess of albumin in urine, a condition known as microalbuminuria, could be an early warning sign of potential kidney disease and may warrant further testing.

"The Accumin test is a major advance in our ability to provide early and accurate detection of microalbuminuria in patients," said Dr. Herbert Ichinose, medical director of Millennium Diagnostics and chief anatomical pathologist at Pendleton Memorial Methodist Hospital. "Millennium Diagnostics is excited to be the first diagnostic laboratory in the region to provide this vital diagnostic tool to physicians and their patients who may be at risk for kidney and other diseases."

Millennium Diagnostics is the latest of a number of influential labs and medical institutions to join AusAm's "Centers of Excellence" program to increase access to the Accumin albumin test. These centers offer the Accumin Direct Total Intact Albumin Assay to patients with a high risk of developing kidney disease, such as diabetics. Millennium closely follows the Hospital of St. Raphael in Connecticut, which last month announced that it had entered AusAm's Centers of Excellence program.

"Accumin is quickly becoming a critical diagnostic tool for twenty million American diabetics who need to accurately screen for potential early-stage kidney disease," said James McCullough, Chief Executive Officer of AusAm Biotechnologies, Inc. "AusAm welcomes Millennium Diagnostics and Dr. Ichinose, who has more than thirty years experience as a regional leader in attending to the health care needs of the Greater New Orleans area, as the latest member of the Centers of Excellence program."

Traditional urine tests do not directly measure albumin. According to a study published in the American Journal of Kidney Diseases, traditional indirect measurement may "severely underestimate" the amount of albumin in the urine of certain patients. In this study, Accumin identified the presence of microalbuminuria in 33 percent of urine samples from diabetic patients where the conventional urine testing showed normal levels. As with other albumin assays, repeated measurements of excretion rates with Accumin over a period of time are appropriate because of high variability of albumin excretion.

For many years, conventional urine testing has been the standard method for detecting albumin in urine. However, traditional urine tests do not directly measure the amount of albumin in the urine, and may underestimate the presence of this protein in certain patients. The Accumin Direct Total Intact Albumin Assay relies on a direct method of measurement, know as chromatography, which detects intact protein in urine that may be undetectable by current diagnostics.

When kidney disease is identified in its initial stages, clinical evidence shows that its progression may be slowed, halted, and, in some cases, reversed with appropriate drug therapies. Patients considered at risk include those with diabetes and hypertension. Diabetes is the single leading cause of kidney failure in the U.S., accounting for more than 44 percent of the people who start treatment for kidney failure each year. The National Kidney Foundation recommends that everyone with diabetes between the ages of 12 and 70 years have a urine test for microalbuminuria at least once a year.

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 to enhance the accuracy and sensitivity of microalbuminuria testing. 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

About Millennium Diagnostics

Millennium Diagnostics is a regional pathology practice specializing in Histology, Cytology, Cytogenetics and Molecular pathology, serving area physicians and researchers for more than 30 years. Herbert Ichinose, M.D., serves as Medical Director for Millennium Diagnostics and Chief Anatomical Pathologist at Pendleton Memorial Methodist Hospital.

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 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

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:May 4, 2004
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