Plague and Tularemia Detection Kits Receive FDA Clearance
Idaho Technology, Inc. (ITI), have received clearance from the FDA for the marketing of two new biothreat detection kits, the JBAIDS Plague and JBAIDS Tularemia Detection Kits. Both kits utilize real-time PCR technology to identify the causative agents of plague (Yersinia pestis) and tularemia (Francisella tularensis).
While naturally occurring cases of Yersinia pestis and Francisella tularensis are rare, both of these agents are classified as Category A Select Agents by the CDC. Category A agents are high priority organisms that pose a risk to national security because they can be used as agents of bioterrorism. Clearance by the FDA allows both reagent kits to be used to help ensure that the country is better prepared to respond to a bioterrorism attack.
The two pathogen detection kits join ITIs growing portfolio of kits used in conjunction with the companys detection instruments and extend the companys leadership position in the biothreat detection market. The detection kits are intended for use by trained clinical laboratory personnel who have received specific training on the use of the JBAIDS Plague and Tularemia Detection kits, for on-site analysis of dangerous biological pathogens.
Todd Ritter, Chief Corporate Development Officer, said, "Idaho Technology continues to add capability to its existing systems making our military first responder customers better prepared to do their important work. Our infectious agent pathogen kits provide additional tools for making decisions and protecting the country."
These kits come after the 2005 FDA clearance of ITIs Joint Biological Agent Identification and Diagnostic System (JBAIDS) for use as an aid in the diagnosis of anthrax. The JBAIDS Plague and JBAIDS Tularemia Detection Kits can be used to test blood, sputum, positive blood cultures and colonies and yield results MRKT-PRT-0128 Rev 01 in less than four hours. The current method of growing, isolating and identifying a culture can take as long as a several days for results.
Idaho Technology remains at the forefront of biothreat detection and maintains a staff of scientists dedicated to the development of pathogen detection reagents. The company plans to next seek FDA clearance for the JBAIDS Brucellosis Detection Kit.
NOTE: This item is from our 'historic' database and may contain information which is not up to date.
Source : Idaho Technology Inc. [USA]
Now part of BioFire Diagnostics, Inc. View Company Information
Posted on January 18, 2008