FDA approves FilmArray Respiratory Panel EZ detection and diagnosis device

7 November 2016 (Last Updated November 22nd, 2018 11:20)

The US Food and Drug Administration (FDA) has granted clinical laboratory improvement amendments (CLIA)-waiver to the FilmArray Respiratory Panel EZ detection and diagnosis device to be used in non-laboratory environments.

The US Food and Drug Administration (FDA) has granted clinical laboratory improvement amendments (CLIA)-waiver to the FilmArray Respiratory Panel EZ detection and diagnosis device to be used in non-laboratory environments.

Funded by the Defense Threat Reduction Agency's Joint Science and Technology Office and BioFire Diagnostics, the new device has been developed for the rapid detection and diagnosis of  illnesses affecting the defence forces.

The CLIA waiver will enable the testing of the device by everyday users, such as at doctor's offices and clinics.

"The sure-fire device allows for quicker medical care for deployed warfighters, especially those on ships or in areas without access to more definitive care."

The molecular diagnostic test will provide the Department of Defense and health workers real-time force protection capabilities to detect and diagnose diseases such as influenza that cause public health concerns.

DTRA joint science and technology office director Dr Ronald Hann said: "The FilmArray RP EZ device is an important part of a suite of detection and diagnosis tools currently under development for the protection of our troops.

"The sure-fire device allows for quicker medical care for deployed warfighters, especially those on ships or in areas without access to more definitive care."

The FilmArray RP EZ diagnostic test facilitates integrated sample preparation, amplification, detection and analysis of 14 viral and bacterial pathogens associated with respiratory infections.

It requires an hour of turnaround time to produce accurate results. The easy-to-use device requires lesser employee time and training which leads to a maximised productivity and work efficiency in the laboratory.