Walter Reed Evaluation Concludes FirstVue(TM) HBSAG Test is Preferred over Other R...(e providing the military said Jonathan ...),Health

Date:10/13/2008

e providing the military," said Jonathan Barash President of AT First Diagnostic. "We are eager to complete our paperwork for the FirstVue(TM) HBSAG test and submit our findings and applications for both FDA and CE registrations on this product. Based on the performance data generated to date, we believe this test will play an important role in identifying HBSAG infections in the future and will enable infected individuals to receive the proper care and treatment they need."

This extensive study was conducted at The Walter Reed Army Institute of Research and involved investigators from the Walter Reed Army Institute of Research Division of Retrovirology, The U.S. Military HIV Research Program, Walter Reed Army Institute of Research Division of Military Casualty Research, the U.S. Army Blood Program, the Army Medical Department Center and School, the Robertson Blood Center and the American Red Cross.

Rapid Hepatitis "B" or "C" tests are not currently available for commercial sale in the United States by the U.S. Food and Drug Administration ("FDA"). AT First Diagnostic is in the process of collecting all the technical data together in order to obtain FDA guidance and approvals for this HBSAG test utilizing multiple specimen types, whole blood, plasma and serum. The data stage is nearing completion and a pre-market application will be in progress for submission to the FDA soon.

Hepatitis B is a potentially life-threatening liver infection caused by the Hepatitis B virus. It is a major global health issue and the most serious type of viral hepatitis. It can cause chronic liver disease and puts people at high risk of death from cirrhosis of the liver and liver cancer.

Approximately 2 billion people worldwide have been infected with the virus and about 350 million live with chronic infection. About 25% of adults who become chronically infected during childhood later die from liver cancer or cirrhosis (scarring of the liver). Hepatitis B virus
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SOURCE AT First Diagnostic LLC Copyright©2008 PR Newswire. All rights reserved

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