Idaho Technology, Inc. Plague and Tularemia Detection Kits Receive FDA Clearance

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Idaho Technology, Inc. (ITI), a molecular biology instrumentation and reagents business in Salt Lake City, Utah, is proud to announce clearance from the Food and Drug Administration (FDA) for 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).

Idaho Technology, Inc. (ITI), a molecular biology instrumentation and reagents business in Salt Lake City, Utah, is proud to announce clearance from the Food and Drug Administration (FDA) for 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 Centers for Disease Control and Prevention (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 ITI's growing portfolio of kits used in conjunction with the company's detection instruments and extend the company's 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 ITI's 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 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.

"This is a great example of how private industry and the government can work as partners to protect our nation and those who defend it. Working closely with the FDA, Center for Devices and Radiological Health (Office of In Vitro Diagnostic Device Evaluation and Safety), our team consisted of the Joint Program Executive Office for Chemical and Biological Defense (specifically the Chemical Biological Medical Systems Joint Project Management Office) and our scientists and staff at Idaho Technology. The team worked extremely hard and effectively to get the system cleared, providing a capability to make our military personnel safer," claims Ritter. "We would also like to thank the Army, Navy and Air Force laboratories that performed the clinical trials and helped with the evaluations, as this was truly a joint effort."

In 2003, the JBAIDS was selected by the U.S. Department of Defense as the platform for rapidly identifying multiple deadly pathogens associated with bioterrorism and diseases of military interest.

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.

About Idaho Technology, Inc.

Idaho Technology Inc., based in Salt Lake City, Utah, is the originator of rapid DNA analysis with applications including DNA amplification, real-time PCR and mutation discovery. ITI's systems include biothreat detection systems (R.A.P.I.D.® and the RAZOR® instruments), a biomedical research system for gene quantification and mutation scanning (LightScanner system), and a food security system (R.A.PI.D. LT). Founded in 1990, ITI is a privately held company focused on worldwide applications in the defense, research, industrial, and food security testing markets. For more information, please visit http://www.idahotech.com.

Source: Idaho Technology, Inc.

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