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DIATHERIX获准销售DIATHERIX H1N1-09流感筛检

DIATHERIX2009年10月24日 23:21 点击:1656

未上市公司DIATHERIX Laboratories宣布,获得美国FDA紧急授权销售,DIATHERIX H1N1-09流感筛检,这种方法利用公司专有分子技术Target Enriched MultiplEX Polymerase Chain Reaction,侦测H1N1-09流感病毒RNA。(PFE)

连接是Diatherix公司通过路透社发布的新闻

DIATHERIX Laboratories Receives FDA Emergency Use Authorization for the
Detection of the Influenza A H1N1-09 Pandemic Flu





HUNTSVILLE, Ala., Oct. 13 /PRNewswire/ -- 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.


Available Topic Expert(s): For information on the listed expert(s), click
appropriate link.


Dennis Grimaud
http://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=86216


SOURCE  DIATHERIX Laboratories, Inc.

Robin Embry of Lovell Communications Inc., +1-615-297-7766, robin@lovell.com
(来源: DIATHERIX )


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