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Diatherix Laboratories Releases First Clinically Available Test For Confirmation of The Swine Flu Virus
Date:5/7/2009

Test can accurately confirm the H1N1 virus in six hours or less

HUNTSVILLE, Ala., May 7 /PRNewswire/ -- Diatherix Laboratories Inc. (www.diatherix.com) today released the first clinically available test that can definitively diagnose the current strain of H1N1 virus, also known as the swine flu, in six hours or less. The test is now commercially available to hospitals, private physician practices, and public health departments for the rapid confirmation of suspected H1N1 patients.

This test has been added to the company's viral respiratory panel, which uses proprietary molecular technology called Target Enriched Multiplex Polymerase Chain Reaction (Tem-PCR). Samples from confirmed patients, provided by the Centers for Disease Control and Prevention (CDC) and local hospitals, were used to validate the performance of the test. Until now, it took several days to confirm a suspected H1N1 patient due to the numerous rounds of testing needed to make a definitive diagnosis. Diatherix's advanced technology can identify multiple pathogens at one time, allowing them to detect and differentiate between the current strains of the H1N1 virus and other respiratory infections in one fast, accurate test.

"Due to the highly mutative nature of the H1N1 strains, it can be very difficult to diagnose the H1N1 virus with many of the current testing methods," said Jian Han, M.D., PhD, laboratory director at Diatherix and faculty investigator of the HudsonAlpha Institute for Biotechnology. "Because our Tem-PCR technology can test for multiple genetic targets at one time, it is the only rapid molecular test that, from a nasal swab, can detect and differentiate multiple influenza strains and nine other respiratory viruses in a single test. This advanced technology provides physicians an accurate and definitive diagnosis."

Dr. Han was responsible for the development of the Tem-PCR avian flu test for the Asian strain of H5N1 as well as a respiratory infection differentiation test used during the SARS outbreak in China. These tests played a significant role in preventing the spread of SARS and avian flu in Asia.

"Since the Diatherix test allows physicians to quickly differentiate H1N1 patients from those who have similar symptoms, infected patients can be provided proper antiviral therapy in a timely manner," said Dennis Grimaud, chief executive officer of Diatherix Laboratories. "A rapid confirmation of H1N1 patients can mitigate many of the negative economic and social impacts associated with infectious disease outbreaks. For example, if in 24 hours or less we could verify a suspected student was not infected with the H1N1 virus, this could prevent a school district from closing."

For information on using the Diatherix Tem-PCR test for the H1N1 virus, please visit the company's web site at www.diatherix.com or call (866) 656-1179.

Diatherix Laboratories Inc. is located in the Hudson-Alpha Institute for Biotechnology in Huntsville, Ala. Diatherix operates as an independent CLIA-certified clinical laboratory providing advanced multiplex molecular diagnostic services such as Tem-PCR to identify infectious disease to hospitals and the healthcare community. In addition to the H1N1 test, the company has testing panels for other respiratory infections, healthcare-associated infections and Staphylococcus. Diagnostic Network Alliance (DNA), with representative offices throughout the United States, is the exclusive US distributor for Diatherix Laboratory. DNA and Diatherix Laboratories share corporate administrative headquarters in Brentwood, Tenn.

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Dennis Grimaud

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SOURCE Diatherix Laboratories Inc.
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