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Bostwick Laboratories Offers Accumin Urine Albumin Test to Indicate Risk for Complications From Heart and Kidney Disease

Posted on: Wednesday, 9 March 2005, 12:00 CST

Accumin Provides Only Direct Measurement of Urine Protein called Albumin

Bostwick Laboratories today announced it will offer the Accumin(TM) Total Intact Albumin Assay(TM) for detection of the protein albumin in urine. The test provides the only direct, quantitative reading of intact urinary protein. Abnormal levels of urinary albumin, a condition known as microalbuminuria, can indicate elevated risk for developing cardiovascular and kidney disease complications. Bostwick Laboratories will begin offering Accumin in April 2005.

According to the American Society of Nephrology, 18.6 million Americans currently have diabetes with up to 21 percent of those people developing kidney disease. Clinical studies show that if detected in its early stages, severe kidney disease can be slowed, halted and in some cases reversed with common drug therapies. The American Heart Association says that around 58 million Americans have some sort of heart disease and a study published in the Journal of the American Medical Association (JAMA. 2001 Jul 25;286(4):421-6) found that "any degree of albuminuria is a risk factor for CV events in individuals with or without diabetes mellitus (DM)."

"Bostwick Laboratories is committed to providing the most accurate diagnostic tests for physicians and patients nationally," said Janet Johnston, Director of Advanced Cytodiagnostics for Bostwick Laboratories. "There is substantial evidence that albumin in the urine is a critically important warning sign for kidney and heart disease complications. That is why major nephrology and cardiology organizational guidelines recommended testing among at-risk groups."

Dr. David Bostwick, the company's Founder and CEO, added "We are very excited about the addition of Accumin to our testing. Accumin offers an accurate detection method that is backed by multiple peer-reviewed studies. Offering Accumin to physicians keeps us on the cutting edge of patient healthcare which is the very foundation of our company's core values."

Accumin detects albumin and permits measurement of intact albumin not identified by current antibody and dye-binding tests. Published studies have shown Accumin can detect abnormal levels of albumin in urine up to 12 years earlier than conventional urine albumin testing. With Accumin, the potential for false negative results is reduced as compared to conventional commercial assays that fail to detect all intact albumin in the urine. 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.

"Bostwick Laboratories is well known for its leadership in the diagnosis of kidney and other urological conditions," said James R. McCullough, Chief Executive Officer of AusAm Biotechnologies. "We are striving to make Accumin the most widely available albumin test in the U.S., and are pleased that Bostwick Laboratories will join the growing list of laboratories currently offering this superior diagnostic test."

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

Cleared by the U.S. Food and Drug Administration in August 2003 for the early detection of albumin as an indicator of potential kidney disease, Accumin recently received expanded indications for use for those at-risk for heart disease complications. Accumin was developed by AusAm Biotechnologies as a step-change improvement over conventional tests for urine albumin. Accumin is currently offered by several reference laboratories and hospitals in the United States including Quest Diagnostics Incorporated, Esoterix, Millennium Diagnostics and Specialty Laboratories. 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 heart disease complications. For additional information, please contact AusAm at 212-659-0703 or email inquiries to info@ausambiotech.com.

About Bostwick Laboratories

Bostwick Laboratories is a pathology reference laboratory providing premium service to physicians, patients and managed care organizations. The lab's mission is to help physicians and patients make informed treatment decisions when faced with the diagnosis of cancer and other urologic diseases by providing the best in technical and scientific expertise. Bostwick focuses on diagnosis of cancer of urologic organs (prostate, urinary bladder, kidney and testis) with a special interest in prostate cancer.

Source: Business Wire

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