Arbor Vita Receives FDA Clearance Of Its AVantage(TM) A/H5N1 Flu Diagnostic - First Rapid Test For Avian Influenza In Humans

Main Category: Bird Flu / Avian Flu
Also Included In: Medical Devices / Diagnostics
Article Date: 15 Apr 2009 - 0:00 PDT

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Arbor Vita Corporation (AVC), a biopharmaceutical company developing both diagnostics and therapeutics, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its AVantage(TM) A/H5N1 Flu Test. This is a non-invasive rapid diagnostic device for the specific detection of the avian influenza A/H5N1 virus in humans.  AVC's AVantage A/H5N1 Flu Test detects the influenza virus nonstructural protein 1 (NS1) in specimens from throat swabs or nose swabs collected from patients with flu symptoms.

"We applaud the FDA's efforts to foster fast, early identification of the avian influenza A/H5N1  virus in humans. Rapid, early detection of avian influenza is paramount to early treatment and containment of a deadly disease with pandemic potential,"  said Peter S. Lu, M.D., Founder and Chief Executive Officer of Arbor Vita Corporation.  "We are excited to receive FDA clearance for the first rapid test to diagnose patients with this serious respiratory infection."

While the AVantage flu test is highly sophisticated, it is easy-to-use.  It is a rapid test that can detect the presence of the avian influenza A/H5N1 virus in less than 40 minutes, without complicated sample preparation.

The U.S. Navy was an integral partner in evaluating this flu test for FDA clearance, with the Naval Health Research Center (NHRC) in San Diego, CA providing testing on both archival and prospective clinical specimens to ensure the specificity of the test, while Navy Medical Research Unit-3 (NAMRU-3) provided invaluable access to avian influenza isolates for development and testing.

"This new rapid test will provide an extra level of protection for not only the general U.S. population, but for our forward-deployed troops in areas with avian influenza activity," commented  Dennis Faix, M.D., Commander, NHRC.

Christopher A. Myers, Ph.D., Laboratory Director, Department of Respiratory Diseases Research, NHRC continued, "This test can help detect an isolated case or outbreak in an austere environment, allowing for the rapid, targeted interventions necessary if we hope to contain or slow an avian influenza outbreak."

About AVantage A/H5N1 Flu Test

The AVantage A/H5N1 Flu Test is the first rapid diagnostic device that will be used to detect the H5N1 virus strain from throat swabs or nose swabs collected from patients with flu symptoms.  In studies conducted in collaboration with NHRC and NAMRU-3, the AVC flu test demonstrated exceptional sensitivity and specificity for the H5N1 subtype of influenza A. The AVC flu test utilizes the company's proprietary PDZ protein technology to uniquely detect the virulence factor NS1 protein  from A/H5N1 viruses, which accounts for the excellent sensitivity and specificity of this diagnostic device.

About Influenza Viruses

As of March 30, 2009, the World Health Organization (WHO) had reported 413 confirmed human cases of avian influenza A/H5N1 virus in 15 countries, with 256 deaths.  Influenza is one of the most common acute, highly contagious respiratory infections in humans, caused by immunologically diverse single-stranded-RNA viruses. Among the three types of influenza viruses: A, B, and C, type A viruses are the most prevalent and are associated with most serious epidemics.  There are many subtypes of type A influenza viruses, distinguished on the basis of different surface proteins (hemagglutinin [HA] and neuraminidase [NA] proteins). The H5N1 subtype of influenza A is known to cause life-threatening illness and to date has a high death rate in excess of 60%.

Symptoms of avian influenza virus in humans have included typical influenza-like symptoms (e.g., fever, sore throat, cough, and muscle aches) which progress to more severe respiratory conditions such as pneumonia and acute respiratory distress and other complications.

About NHRC

Naval Health Research Center (NHRC) serves as a leading research and development laboratory for the Department of Defense. NHRC manages and executes expeditionary operational medical research, development and test and evaluation programs for the Naval Medical Research Command, Silver Spring, MD, Navy Medicine Support Command, Jacksonville, FL and the Navy Bureau of Medicine and Surgery (BUMED).

About NAMRU-3

The Naval Medical Research Unit No. 3 (NAMRU-3), based in Cairo, Egypt, conducts infectious disease research, including the evaluation of vaccines, therapeutic agents, diagnostic assays and vector control measures, and performs public health activities, principally aimed toward improved disease surveillance and outbreak response assistance.   NAMRU-3 works closely with the Egyptian Ministry of Health, the U.S. National Institutes of Health (NIH), the World Health Organization (WHO), the U.S. Agency for International Development (USAID) and the U.S. Centers for Disease Control and Prevention (CDC).

About Arbor Vita Corporation

Arbor Vita is a biopharmaceutical company pioneering the discovery, development and commercialization of novel drugs and diagnostics through a new family of targets -- PDZ proteins. PDZ proteins are key cellular organizers in human signaling pathways. Recruited by viral pathogens, PDZ proteins are highly conserved and provide an ideal platform for identification of diagnostic markers for cancers, infectious diseases and other complex diseases. The company capitalizes on its unique mix of expertise, intellectual property, and novel PDZ drug discovery platform to accelerate discovery and development programs for both therapeutics and diagnostics. Arbor Vita's current programs address major health areas including complex diseases such as cervical cancer and stroke, as well as infectious diseases such as influenza.

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Arbor Vita Corporation