NEW HAVEN, Conn.--(BUSINESS WIRE)--April 14, 2004-- Accumin(TM) Provides the First Direct Total Intact Measurement of Protein Albumin in Urine
AusAm Biotechnologies, Inc. today announced that the Hospital of St. Raphael 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. St. Raphael's is part of AusAm's "Centers of Excellence" program to increase access to the Accumin albumin test through influential medical institutions and labs. An excess of albumin in urine, a condition known as microalbuminuria, could be an early warning sign of kidney disease.
"Kidney disease is a widespread medical condition that affects more than 20 million Americans," said Dr. David Stair, a certified specialist in clinical hypertension and a clinical instructor at the Yale University School of Medicine. "It is clear from clinical research that microalbuminuria is an indicator of kidney and other diseases; the earlier we can detect microalbuminuria, the better chance we have of helping our patients at risk."
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.
"The Hospital of St. Raphael is an award-winning medical center affiliated with the prestigious Yale University School of Medicine. We look forward to working with physicians at St. Raphael's and Yale to make Accumin accessible to patients in the Connecticut area," said James McCullough, Chief Executive Officer of AusAm Biotechnologies, Inc. "Our goal with the Centers of Excellence program is to make Accumin the standard of care for patients across the country, and we are delighted St. Raphael's is a part of this effort."
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 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.
About the Hospital of St. Raphael
The Hospital of Saint Raphael is a 511-bed acute care community teaching hospital affiliated with Yale University School of Medicine. A leader in cardiac, cancer, orthopedic, neuroscience and geriatric services, Saint Raphael's is the largest member of the Saint Raphael Healthcare System.
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 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 firstname.lastname@example.org.
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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