ITI receives FDA clearance for new Q fever assay kit

Jun 7 2011

This week the U.S. Food and Drug Administration cleared the first nucleic acid amplification In vitro diagnostic (IVD) test that detects Coxiella burnetii, the bacteria that causes Q fever. The test developed by Idaho Technology, Inc. (ITI) will be used to test military personnel suspected of contracting the disease and run on the Joint Biological Agent Identification and Diagnostics System (JBAIDS), utilized across all branches of the military for diagnostic testing. Use of the test is limited to designated Department of Defense laboratories equipped with the JBAIDS.

Q fever is an emerging infectious disease among U.S. soldiers serving in Iraq and other countries around the globe. The disease is usually transmitted to humans after contact with infected animals or exposure to contaminated environments. The bacteria is extremely hardy and resistant to heat, drying and many common disinfectants which can enable it to survive for very long periods in the environment. Early detection and identification of the bacteria will enable faster treatment and recovery.

"We are very pleased that the JBAIDS capability continues to evolve. Q fever marks the fifth FDA-approved JBAIDS assay kit with many more in the pipeline and expected out soon," said Kirk Ririe, chief executive officer of ITI.