Navigation Links
Anthrax test, developed by army and CDC, receives FDA approval

A method for identifying Bacillus anthracis, the causative agent of anthrax, has been cleared for diagnostic use by the U.S. Food and Drug Administration (FDA). The test, known as the Gamma Phage Assay, was modified by scientists at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to improve its performance and reliability when used with clinical specimens. The original form of the Gamma Phage Assay was first developed by the Centers for Disease Control and Prevention (CDC) in the mid-1950s.

The modified gamma phage method is the first diagnostic test to gain FDA approval for human use within the Laboratory Response Network (LRN). This network, established by the CDC, is charged with maintaining an integrated system of state and local public health, federal, military, and international laboratories that can respond to bioterrorism, chemical terrorism and other public health emergencies.

According to USAMRIID senior scientist John W. Ezzell, the Gamma Phage Assay is a classical bacteriological method that has been used at USAMRIID and other laboratories for years as part of an extensive array of methods used to identify B. anthracis. The gamma phage is a virus capable of entering bacterial cells and causing cell destruction, or lysis--and it is specific to B. anthracis.

"Because of that specificity, the gamma phage gives a highly readable result," Ezzell explained. "Wherever the virus is added to the surface of a culture plate that has been inoculated with suspicious anthrax colony growth, you can see clear zones where the B. anthracis cells have been destroyed--whereas other bacterial cells grow unaffected."

Well before the anthrax attacks of 2001, scientists at USAMRIID and the CDC recognized the need for an FDA accepted method for identifying B. anthracis in clinical specimens. In 2002, FDA's Division of Clinical Laboratory Devices agreed to recognize tests for B. anthracis as eligible for classification w ith a 510(k) premarket notification process--the designation given to devices and other non-biologics.

USAMRIID, with support from CDC, prepared and submitted a 510(k) Premarket Notification using both USAMRIID and CDC data on use of the gamma phage method. With FDA recognition of the assay as substantially equivalent to the classical assay used prior to 1976, it will be available for use for testing in designated civilian and military clinical laboratories.

"This is a big first step in helping to provide the LRN labs with FDA cleared assays," said Judy Sheldon, a regulatory affairs microbiologist with the CDC's Bioterrorism Preparedness and Response Program. "The work done at USAMRIID and here at CDC provided a solid scientific basis for FDA to evaluate the assay performance. This work has set a high bar for other tests to meet."

USAMRIID scientists standardized and validated the test to make it more rugged, more reproducible across laboratories, and more resistant to user error. They developed a clearly defined method for production of gamma phage that proved to be highly stable, as reflected in the extended shelf life of the B. anthracis-specific virus. USAMRIID then provided sufficient gamma phage material to CDC for distribution within the LRN, so that each laboratory will have the same material to be used in the test. In addition, USAMRIID developed Standard Operating Procedures for the assay to ensure that each laboratory in the LRN will run the test the same way. This also increases confidence in the final result.

"This represents a very significant milestone for both of our organizations, in that all of the medical diagnostic products that we are developing must eventually follow a similar pathway for approval to allow clinical diagnosticians to use these tests to positively identify pathogens," said Colonel George W. Korch, Jr., commander of USAMRIID. "Successes such as these demonstrate that we can translate our res earch efforts into products for our health care providers and clinical laboratory professionals."


'"/>

Source:US Army Medical Research Institute of Infectious Diseases


Related biology news :

1. Study Models Impact Of Anthrax Vaccine
2. Anthrax inhibitors identified by Burnham team
3. Anthrax stops body from fighting back, study shows
4. Anthrax spores may survive water treatment
5. Anthrax inhibitor counteracts toxin, may lead to new therapeutics
6. Anthrax attack posed greater potential threat than thought
7. Anthrax paralyzes immune cells with lethal toxin, UF research shows
8. Metacognition: Faced with a test, rats can check their knowledge first
9. Robot-based system developed at Carnegie Mellon detects life in Chiles Atacama desert
10. Disease progression model of pancreatic cancer developed by Penn researchers
11. New HIV drug candidate developed in Sweden
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:3/22/2017)... 2017   Neurotechnology , a provider of ... announced the release of the SentiVeillance 6.0 ... facial recognition using up to 10 surveillance, security ... The new version uses deep neural-network-based facial detection ... utilizes a Graphing Processing Unit (GPU) for enhanced ...
(Date:3/20/2017)... At this year,s CeBIT Chancellor Dr. Angela Merkel visited ... to the DERMALOG stand together with the Japanese Prime Minster Shinzo Abe. ... the largest German biometrics company the two government leaders could see the ... well as DERMALOG´s multi-biometrics system.   Continue Reading ... ...
(Date:3/13/2017)... , March 13, 2017 Future of security: Biometric Face ... ... DERMALOGs Face Matching enables to match face pictures against ... basis to identify individuals. (PRNewsFoto/Dermalog Identification Systems) ... DERMALOG,s "Face Matching" is the fastest software for biometric Face Matching ...
Breaking Biology News(10 mins):
(Date:3/23/2017)... ... ... to announce it has become the premiere team-building cooking event company in San Diego. ... as Illumina, HP and Qualcomm, and is ranked #1 in its category on Trip Advisor. ... new team building format, a way for teams to not only interact with one another ...
(Date:3/23/2017)... MILFORD, Mass. , March 23, 2017 ... leading partner to global in vitro diagnostics ... launch of the industry,s first multiplexed ... inherited disease testing by next-generation sequencing ... materials were developed with input from industry ...
(Date:3/23/2017)... ... March 23, 2017 , ... Ellen Matloff, president and ... Council (CTC) as a 2017 Women of Innovation® finalist. Matloff will be among ... Dinner. , The dinner recognizes women accomplished in science, technology, engineering and math ...
(Date:3/23/2017)... York , March 23, 2017 According ... plasma products and derivatives market is fragmented due to the presence of ... such as Proliant, Thermo Fisher , and Sigma-Aldrich, compete with ... these three companies, collectively, held more than 76% of this market ... As ...
Breaking Biology Technology: