DIATHERIX Laboratories Receives FDA Emergency Use Authorization For The Detection Of The Influenza A H1N1-09 Pandemic Flu

Main Category: Swine Flu
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 14 Oct 2009 - 1:00 PDT

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DIATHERIX Laboratories, Inc. is pleased to announce it has been granted emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its DIATHERIX H1N1-09 Influenza Test. The test utilizes the company's proprietary molecular technology, known as Target Enriched Multiplex Polymerase Chain Reaction (Tem-PCR), which is used for the detection of the H1N1-09 influenza viral RNA.

The DIATHERIX H1N1-09 Influenza Test allows clinicians to quickly and definitively identify H1N1-09 patients, differentiating from those who have similar symptoms. Once accurately identified, infected patients can be provided proper antiviral therapy in a timely manner. Confirmation and appropriate treatment of H1N1-09 patients can mitigate many of the negative economic and social impacts associated with a pandemic influenza outbreak. With turnaround time of 24-hours from sample receipt, clinics, hospitals, physician offices, urgent care centers and public health departments are able to treat and/or contain patients who test positive for the H1N1-09 pandemic flu virus.

DIATHERIX Laboratories provides the test within requirements set forth by the FDA for Emergency Use Authorization; the FDA has not cleared or approved this test. Under the EUA, the FDA has authorized use of DIATHERIX H1N1-09 only for the duration of the declaration of emergency. The test is intended to be used on nasopharyngeal swabs, nasal swabs, throat swabs and nasal aspirates from patients with signs and symptoms of respiratory infection in conjunction with clinical risk factors.

For information on using the DIATHERIX Tem-PCR test for the H1N1-09 virus, please visit the company's web site at www.DIATHERIX.com or call (866) 656-1179. DIATHERIX Laboratories, Inc. is located in the HudsonAlpha Institute for Biotechnology in Huntsville, Ala. DIATHERIX operates as an independent CLIA-certified clinical laboratory providing advanced multiplex molecular diagnostic services to assist healthcare providers in the detection of infectious disease. An executive office for Diatherix and headquarters for Diagnostix Network Alliance, the exclusive representative for Diatherix Laboratories, are located in Brentwood, Tenn.

Source: DIATHERIX Laboratories, Inc

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