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AusAm's Accumin Urine Albumin Test Receives Expanded Indications for Use for Those At-Risk for Heart Disease Complications

Posted on: Wednesday, 8 December 2004, 12:00 CST

FDA Expands Label for Measurement of Urinary Protein to Aid in the Identification of Patients Who Warrant Further Testing for Cardiovascular Disease

AusAm Biotechnologies, Inc. today announced that Accumin(TM) has received expanded labeling to its 510(k) from the U.S. Food and Drug Administration (FDA) for "diagnostic use in quantitation of intact albumin in urine from patients with cardiovascular diseases associated with increased albumin levels."

The early and accurate detection of urinary albumin could help in the identification of patients who are at risk for a cardiovascular event and warrant further testing. Accumin received its original FDA clearance for the early detection of albumin as an indicator of potential kidney disease in August 2003.

"Among patients with cardiovascular disease, it is important to identify early on, those individuals who are at greatest risk of heart attack, stroke or death. Thorough evaluation of the at-risk patient allows physicians to intervene with appropriate treatment options which may greatly reduce the chance of a catastrophic event," said Dr. Jaime Gerber, Assistant Clinical Professor at the Yale University School of Medicine and Director of Quality Assurance at the Yale Heart Center. "The presence of increased urinary albumin is a clinically proven warning sign that a heart disease complication is a strong possibility. Individuals with risk factors for heart disease such as hypertension and diabetes who show increased levels of albumin in the urine have much higher rates of stroke, kidney failure, heart attack and cardiovascular death. Accumin represents an improvement on current testing for urinary albumin which will help us better identify those who are at risk for cardiovascular disease complications."

The presence of relatively high levels of albumin in urine, a condition known as microalbuminuria, has been linked in clinical research to the onset of both kidney and cardiovascular diseases. In fact, a study published in the Journal of the American Medical Association found that any degree of albuminuria is a risk factor for cardiovascular events in individuals with or without diabetes, and suggested that screening for albumin in urine identifies people at high risk for cardiovascular events. Accumin has demonstrated enhanced sensitivity in detecting intact albumin compared to conventional tests for urinary protein. The assay uses common laboratory equipment to separate albumin from the other compounds in urine to determine its precise quantity, offering the most accurate reading currently available. Conventional urine tests fail to measure intact immuno-unresponsive urinary albumin. As reported in an article published in the American Journal of Kidney Disease, this can result in a "false negative" for intact albumin. As with other albumin assays, repeated measurements of excretion rates over a period of time are appropriate because of high variability of albumin excretion. A positive finding of microalbuminuria with Accumin warrants further testing.

"This expanded labeling continues to support the clinical evidence that the early detection of the protein albumin in urine can be a critical, early warning sign of potential cardiovascular and/or kidney disease complications," said James R. McCullough, Chief Executive Officer of AusAm Biotechnologies, Inc. "AusAm Biotechnologies believes that Accumin provides physicians with a measurement enabling further, more accurate classification of those at-risk for disease, increasing opportunities to potentially save additional lives and avoid the complications and expense of late-stage illness."

The Centers for Disease Control estimates that about 57 million Americans live with some form of cardiovascular disease, which causes more than 40 percent of all deaths in the United States. In addition, the National Kidney Foundation estimates that more than 40 million Americans have kidney disease or are at risk for developing kidney disease. Studies show that, if detected in its initial stages, the onset of kidney disease and cardiovascular disease can be slowed, halted and in some cases reversed with common drug therapies such as angiotensin converting enzyme (ACE) inhibitors and angiotensin-2 receptor blockers (ARBs). Medical experts and health organizations are emphasizing the importance of conducting proactive albumin screenings in an effort to reduce the number of patients living with these potentially fatal conditions.

An International Symposium of Albuminuria, made possible by AusAm Biotechnologies, took place in New York last May. Throughout the event, which gathered together thought leaders in nephrology, cardiology and epidemiology, a broad array of research was presented on albumin's predictive power as a risk marker and therapy target, its mechanism of action and advances in how it is measured. The results, which were subsequently published in a supplement to Kidney International, illustrate that albuminuria is an independent risk marker for kidney and cardiovascular disease complications, not only in at-risk patients such as diabetics, but also in the general population. Initial data also suggests that albuminuria can potentially serve as an independent therapy target, irrespective of cholesterol, blood pressure and other commonly used drug efficacy parameters.

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

Source: Business Wire

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