• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

AusAm's Accumin Urine Albumin Test to Indicate Risk of Complications From Heart and Kidney Disease to Be Available to Hospitals Nationwide Through Quest Diagnostics

Posted on: Tuesday, 21 December 2004, 09:00 CST

AusAm Biotechnologies, Inc. announced today that its Accumin(TM) test for detection of the protein albumin in urine will be offered by Quest Diagnostics Incorporated (NYSE: DGX), the nation's leading provider of diagnostic testing, information and services. The presence of relatively high levels of albumin in the urine, a condition known as microalbuminuria, is an indicator of elevated risk for developing cardiovascular disease complications and kidney disease. The test will be available to hospital-based physicians nationwide in the first quarter of 2005 through Quest Diagnostics. Terms of the transaction were not disclosed.

A study published in the Journal of the American Medical Association (January 2002) found that "any degree of albuminuria is a risk factor for CV events in individuals with or without diabetes mellitus (DM)." Earlier this month, the Accumin test received expanded labeling to its 510(K) from the U.S. Food and Drug Administration. The original clearance allowed Accumin to be used for the quantitation of intact albumin in urine in patients who may warrant further testing for kidney or intestinal disease. It may now also be used to measure intact albumin in patients with cardiovascular diseases associated with increased albumin levels.

"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."

In clinical studies, Accumin has been shown to identify patients with microalbuminuria up to twelve years earlier than leading conventional tests such as radioimmunoassay or turbitimetry. Accumin reduces the risk of false negatives for microalbuminuria which can occur a minimum thirty-three percent of the time with conventional testing (source: American Journal of Kidney Disease, High Prevalence of Immuno-Unreactive Intact Albumin in Urine of Diabetic Patients, February 2003). As with other albumin assays, repeated measurements of excretion rates over time are appropriate because of high variability of albumin excretion. A positive finding of microalbuminuria with Accumin warrants further testing.

AusAm Biotechnologies is supporting the development of nationwide physician education and patient awareness programs. These will be initiated first in the Northeastern United States, with the goal of raising awareness of the importance of testing for microalbuminuria with Accumin, and increasing understanding of the high-risk populations who should be tested and what's needed to reduce the impact of disease.

Last month, the International Society of Nephrology (ISN) recommended national health bodies in developed countries to consider the urgent implementation of systematic and thorough microalbuminuria screening in subjects considered to be at high risk of either enhanced renal function loss or cardiovascular function loss, such as patients with type 2 diabetes and hypertension; people who are obese or smoke; are over 50 years of age; or, have a family history of heart and kidney disease and/or diabetes and hypertension.

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 urine albumin. 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

More News in this Category