Navigation Links
'Mad cow' proteins successfully detected in blood

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:University of Texas Medical Branch at Galveston

Related biology news :

1. New, automated tool successfully classifies and relates proteins in unprecedented way
2. UWs Rosetta software to unlock secrets of many human proteins
3. Global analysis of membrane proteins
4. UNC plant researchers discover proteins interact to form hair-trigger protection against invaders
5. Researchers develop new method for facile identification of proteins in bacterial cells
6. Hopkins scientists uncover tags that force proteins to cell surface
7. Researchers create functioning artificial proteins using natures rules
8. UCSD discovery may provide novel method to generate medically useful proteins
9. Prostate cancer uses Wnt signaling proteins to promote growth of bone tumors
10. A real time look at interactions between RNA and proteins
11. New evidence questions the simple link between prion proteins and madcow disease
Post Your Comments:

(Date:11/11/2015)... Minn. , Nov. 11, 2015   MedNet Solutions ... entire spectrum of clinical research, is pleased to announce that ... in Clinical Trials (PCT) event, to be held November ... be able to view live demonstrations of iMedNet ... and learn how iMedNet has been able to ...
(Date:11/9/2015)... DUBLIN , Nov. 09, 2015 /PRNewswire/ ... announced the addition of the "Global ... to their offering. --> ... "Global Law Enforcement Biometrics Market 2015-2019" ... Research and Markets ( ) ...
(Date:11/2/2015)... PARK, Calif. , Nov. 2, 2015  SRI ... $9 million to provide preclinical development services to the ... the contract, SRI will provide scientific expertise, modern testing ... wide variety of preclinical pharmacology and toxicology studies to ... --> The PREVENT Cancer Drug Development ...
Breaking Biology News(10 mins):
(Date:11/27/2015)... ... November 27, 2015 , ... Pittcon is pleased to ... presentations offered in symposia, oral sessions, workshops, awards, and posters. The core ... of applications such as, but not limited to, biotechnology, biomedical, drug discovery, environmental, ...
(Date:11/25/2015)... November 26, 2015 ... Market 2016 - 2020 report analyzes that automating ... and quality in long-term samples, minimizing manual errors, ... Automation minimizes manual errors such as mislabeling or ... Further, it plays a vital role in blood ...
(Date:11/25/2015)... and HOLLISTON, Mass. , Nov. ... (Nasdaq: HART ), a biotechnology company developing bioengineered ... Jim McGorry will present at the LD ... 2015 at 2:30 p.m. PT. The presentation will be ... 30 days. Management will also be available at the ...
(Date:11/25/2015)... -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX ) today ... discussion at the Piper Jaffray 27th Annual Healthcare Conference ... is scheduled for Wednesday, December 2, at 8:00 a.m. ... will be available for 14 days after the event.  ... Corporate Communications and Business Development , BrewLife(858) 875-8629 ...
Breaking Biology Technology: