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Longhorn Vaccines & Diagnostics LLC Receives FDA Emergency Use Authorization (EUA) for the First 2009 H1N1 Influenza Assay to Include a Molecular Transport Medium (MTM)
Date:2/23/2010

e, rapid testing will significantly improve the quality and timeliness of care we can provide -- in both hospital/ED, and community health settings," stated international health expert, R. Scott Altman MD, MPH, MBA, FACEP, Assistant Professor of Clinical Emergency Medicine at the Northwestern University Feinberg School of Medicine.

Longhorn Vaccines and Diagnostics will continue the development of the Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay™ and expects to submit a separate 510(k) in 2010.

About the FDA's Emergency Use Authorization

The US Secretary of Health and Human Services has declared a public health emergency because of the outbreak of the pandemic flu virus. The FDA has issued emergency use authorizations to make diagnostic and therapeutic tools available to public health and medical personnel for use in the diagnosis of 2009 H1N1 influenza virus under certain circumstances.

The FDA has not cleared or approved any tests for the identification of the 2009 H1N1 influenza virus. The emergency use authorization authority allows the FDA, based on the e
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SOURCE Longhorn Vaccines & Diagnostics
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