FDA clears Q fever test

The U.S. Food and Drug Administration has cleared the first nucleic acid amplification in vitro diagnostic test that detects Coxiella burnetii, a bacterium that causes Q fever.

The test, developed by Idaho Technology, Inc., will be utilized across all branches of the military for diagnostic testing and will be run on the Joint Biological Agent Identification and Diagnostic System for designated Department of Defense laboratories.

Q fever has emerged as an infectious disease among U.S. soldiers serving in Iraq and other countries throughout the world. The disease transmits to humans from infected animals or exposure to environments contaminated with the bacteria. Coxiella burnetii is very hardy, resistant to heat and drying, and resists many common disinfectants, allowing it to survive for a long time in the environment. By focusing on earlier identification and detection of the bacteria, faster treatment and recovery will be more possible.

“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,” Kirk Ririe, chief executive officer of ITI ,said.

Idaho Technology, Inc., is a privately held biotechnology company founded in 1990 and based in Salt Lake City, Utah. The company has created multiple commercial instruments and reagents for use in research and applied fields through funds from the United States Department of Health and Human Services and the Department of Defense.