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FDA clears first ever diagnostic test for Q fever

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The FDA has cleared the first nucleic acid amplification test to diagnose the early stages of Q fever infections in military personnel serving overseas, according to an FDA press release.

“It’s important that the FDA protect our troops from biothreats using innovative diagnostics,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “Q fever bacteria are considered a biothreat agent in part due to the fact that fewer than 10 organisms need to be inhaled to cause infection and its ability to withstand open environments.”

The test — developed by Idaho Technology Inc. and funded by the Chemical Biological Medical System Joint Project Management Office within the US Department of Defense — identifies and detects Coxiella burnetii in a patient’s blood sample within 4 hours. Use of the test is limited to designated Department of Defense laboratories equipped with the department’s Joint Biological Agency Identification and Diagnostic System.

According to the CDC, Q fever was first recognized as a human disease in Australia in 1935 and in the US during the early 1940s.

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