U.S. regulator approves rapid test for bird flu

[HenryN]

U.S. regulator approves rapid test for bird flu

Tue Apr 7, 2009 6:21pm EDT
WASHINGTON, April 7 (Reuters) - The U.S. Food and Drug Administration said on Tuesday it had approved a fast test for H5N1 bird flu that can show in less than an hour if people are infected.
The test, made by Sunnyvale, California-based Arbor Vita Corporation, should greatly speed up diagnosis and treatment of people infected with avian influenza, the FDA said. Most current tests take hours.
"This test is an important tool to help quickly identify emerging influenza A/H5N1 infections and reduce exposure to large populations," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.
"The clearance of this test represents a major step toward protecting the public from the threat of pandemic flu."
H5N1 mostly affects birds, but it occasionally infects people and is deadly when it does. The World Health Organization says 413 people have been infected and 256 have died in 15 countries since 2003.
Quick treatment with Riche AG (ROG.VX: Quote, Profile, Research, Stock Buzz) and Gilead Sciences Inc's (GILD.O: Quote, Profile, Research, Stock Buzz) drug Tamiflu can help save lives but usually people are not diagnosed right away.
"The test, called AVantage A/H5N1 Flu Test, detects influenza A/H5N1 in throat or nose swabs collected from patients who have flu-like symptoms," the FDA said in a statement.
"The test identifies in less than 40 minutes a specific protein (NS1) that indicates the presence of the influenza A/H5N1 virus subtype. Previous tests cleared by the FDA to detect this influenza A virus subtype can take three or four hours to produce results."
Experts fear H5N1 could mutate into a form that spreads easily from person to person. If it did, it would cause a pandemic that could kill millions and devastate economies. Governments are trying to prepare for such an epidemic by stockpiling drugs, vaccines and diagnostic tests. (Reporting by Maggie Fox; editing by Chris Wilson)



http://www.reuters.com/article/governmentFilingsNews/idUSN0749228120090407?rpc=401&

 

[HenryN]

Re: U.S. regulator approves rapid test for bird flu

Sending some sample test kits to Egypt might be a good idea.

 

[AlaskaDenise]

Re: U.S. regulator approves rapid test for bird flu

Arbor Vita Receives FDA Clearance of Its AVantage(TM) A/H5N1 Flu Diagnostic First Rapid Test for Avian Influenza in Humans

SUNNYVALE, CA -- (Marketwire) -- 04/07/09 -- 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 (www.arborvita.com) 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.


http://www.pr-inside.com/arbor-vita-receives-fda-clearance-of-r1170513.htm

 

[AlaskaDenise]

Re: U.S. regulator approves rapid test for bird flu

Perhaps NAMRU-3 has already begun using the tests as part of their stated mission.

.

 

[AlaskaDenise]

Re: U.S. regulator approves rapid test for bird flu

From Arbor Vita site:
--------------------------------------

Harnessing the Power of PDZs?Recent studies in animals have shown PDZ-based therapeutics to be efficacious in a setting where conventional drugs have failed due to intolerable side effects. These studies demonstrate that PDZ proteins are a new class of drug target, operating inside the cells, which are amenable to regulation using drugs. PDZ proteins are important in numerous human diseases and are just being recognized as an ideal human drug target.

Many proteins in cells are tagged at their tail end, or C-terminus, with a code that instructs the cell to distribute the protein to its proper location. This code, called the PDZ ligand or PL, is read and decoded by PDZ proteins that direct the distribution of the tagged protein. Arbor Vita Corporation has identified nearly all of the PDZ domains in the human proteome and has decoded most of them. The company has applied this knowledge to its discovery and development of novel diagnostics and therapeutics, including a new treatment for stroke and a rapid test for avian influenza.

Importance to human biology

PDZ proteins are named for the first letter of the first three proteins in the family to be discovered (PSD-95, DLG, and ZO-1). PDZs play a key role in cellular signaling, initiating and regulating the assembly of proteins including membrane proteins, cytoskeletal proteins, kinases and other proteins. Interrupting the interaction of PDZ proteins with their protein ligand (PL) binding partners may present a novel opportunity to control multiple signaling cascades in complex diseases, offering the potential for the development of stroke and cardiac therapeutics, and treatments for cancer, Alzheimer's disease, Parkinson's disease and inflammation among others.

Role in cell signaling

The structural features of PDZ domains allow them to mediate specific protein-protein interactions that underlie the assembly of large protein complexes involved in signaling or subcellular transport. PDZ domain-containing proteins play central roles in organizing signal transduction complexes, clustering membrane receptors and maintaining cell polarities. The PDZ protein-protein interaction is targetable because this interaction occurs in a protein pocket, formed by the PDZ domain. By targeting specific PDZ protein interactions, the specific functions of the signaling pathways are targeted, allowing development of therapeutics that have a narrow focus. In addition, AVC has isolated all known PDZ domains in the human genome and developed a platform that allows early-stage development of drugs that are selective for the PDZ domain of interest, allowing a significant increase in successful development at reduced time and cost.

http://www.arborvita.com/science.html

 

[tropical]

Re: U.S. regulator approves rapid test for bird flu

#1:
""This test is an important tool to help quickly identify emerging influenza A/H5N1 infections and reduce exposure to large populations," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.
"The clearance of this test represents a major step toward protecting the public from the threat of pandemic flu.""

:applause:

 

[HenryN]

Re: U.S. regulator approves rapid test for bird flu

Perhaps NAMRU-3 has already begun using the tests as part of their stated mission.

.

At the Cairo Proving Ground?

 

[Laidback Al]

Re: U.S. regulator approves rapid test for bird flu

additional information from Arbor Vita site:

AVC Influenza Diagnostics
Arbor Vita Corporation received 510(k) clearance from the U.S. Food and Drug Administration in April 2009 for its rapid diagnostic test for the H5N1 influenza A viral subtype (avian or bird flu). The AVantage? A/H5N1 Flu Test is the first PDZ proteomics rapid test for the specific detection of H5N1. The test requires no equipment or cold storage, is easy to use and gives results within 45 minutes from start to finish. These features are critical for rapid response to possible H5N1 outbreaks. The AVantage? A/H5N1 Flu Test utilizes the company's proprietary PDZ technology to distinguish H5N1 from seasonal influenza A infections. This AVC PDZ proteomics technology is the engine that drives the high specificity and sensitivity of the test. AVC adapted PDZ proteomics to a rapid format to create this unique capability.
In collaboration with the U.S. Naval Health Research Center in San Diego, California, AVC completed a clinical trial of nearly 500 symptomatic patients [????] that demonstrated high clinical specificity for the test. Testing at NAMRU-3 (U.S. Naval Medical Research Unit No. 3) in Cairo, Egypt demonstrated excellent sensitivity with human H5N1 culture samples.
AVC is also developing a next generation test for Flu A/Flu B (seasonal flu) that promises to be more sensitive and specific than currently available diagnostics. Using nasal and throat specimens, (rather than nasopharyngeal specimens that are unpleasant for the patient), the AVC Flu A/Flu B test is expected to provide early detection (first 2 days) of seasonal flu infections. Early detection allows timely use of antiviral drugs that work best if given in the first two days of influenza infection.

http://www.arborvita.com/products_AVCDX2.html

 

[AlaskaDenise]

Re: U.S. regulator approves rapid test for bird flu

At the Cairo Proving Ground?

Specifically the suspected T2T-area!

.

 

[AlaskaDenise]

Re: U.S. regulator approves rapid test for bird flu

....clinical trial of nearly 500 symptomatic patients [????]

remember all the symptomatic patients going to the hospital last year? Perhaps it was part of the clinical trial.

.

 

[tropical]

Re: U.S. regulator approves rapid test for bird flu

remember all the symptomatic patients going to the hospital last year? Perhaps it was part of the clinical trial.

.

Perhaps we are all into an big earthwide trial

Quote:
<TABLE cellSpacing=0 cellPadding=6 width="100%" border=0><TBODY><TR><TD class=alt2 style="BORDER-RIGHT: 1px inset; BORDER-TOP: 1px inset; BORDER-LEFT: 1px inset; BORDER-BOTTOM: 1px inset">....clinical trial of nearly 500 symptomatic patients [????] </TD></TR></TBODY></TABLE>

The meaning of "symptomatic" can be quite prosaic also,
it could mean the (un)usual flu-like initial symptoms which make all of them eligible to be tested, and the test would reveal if some of them have the AH5N1 virus, or not - if not the viruses would be from the other flu/ards/... group.

 

[camster]

Re: U.S. regulator approves rapid test for bird flu

#1:
""This test is an important tool to help quickly identify emerging influenza A/H5N1 infections and reduce exposure to large populations," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.
"The clearance of this test represents a major step toward protecting the public from the threat of pandemic flu.""

:applause:

Expect the CDC to take a different opinion.....

 

[camster]

Re: U.S. regulator approves rapid test for bird flu

remember all the symptomatic patients going to the hospital last year? Perhaps it was part of the clinical trial.

.

To test the assay against true H5N1 cases would have been nearly impossible for a number of reasons, logistical and political. The next best option, and crucial for another reason I'll mention below, is to test against circulating seasonal (i.e. H3N2, H1N1) influenza strains found in humans.

This also allows you to assay the device for the dreaded false positive. Sending up "Bird flu!!!" flags w/o confirmation is a bad thing to do for a number of reasons. Also, its best to try out the test in question in the population it's intended for. People carry all sorts of nasty bugs that may react with the product.

so here, symptomatic simply means they presented with Flu-like illness. In this case, fevers were often subjectively self-reported.

 

[camster]

Re: U.S. regulator approves rapid test for bird flu

Sending some sample test kits to Egypt might be a good idea.

They do have some, and were a big part of the trial (the crucial bit in fact. one can test expected negatives all day w/o any gain of confidence!) That being said, deploying the test in a foreign country still requires the cooperation of local governments. In this case, the Egyptian Minister of Health has been informed of the test and it's capabilities. (He was made aware prior to the start of the trial and certainly interested in the results.) Also note the clearance was for the US only.

So in the end it will be the decision of the MOH. What would be nice is funding to support such a deployment. I'm sure you've all seen the number of children that have been hit by the disease in Egypt lately. :surrender:

But yes, having these kits there for further testing is needed.