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BioFire Received FDA Clearance for Updated FilmArray® Respiratory Panel Improving Sensitivity and Reactivity of Adenovirus Detection

Biofire Diagnostics
5 Mar 2013

Product news

BioFire Diagnostics, Inc. announced today the FDA clearance of its updated FilmArray Respiratory Panel. The purpose of the updated panel is to improve detection of Adenovirus. Studies performed to support the clearance of the modified panel demonstrated a 73% increase in the detection of Adenovirus and a 3-fold improvement in the limit of detection when compared to the original panel.

All existing assays for the 20 viral and bacterial targets in the original Respiratory Panel are unchanged. The updated panel includes an additional assay designed to increase sensitivity and reactivity for the detection of Adenovirus. BioFire plans to make the updated panel available to its customers in April.

Kirk Ririe, Chief Executive Officer of BioFire Diagnostics, said, “We are pleased that the updated FilmArray RP has received FDA clearance. BioFire continually strives to increase the quality of its products. The increased sensitivity and reactivity of the Adenovirus assay shows our commitment to customers and to providing accurate test results. With an improved Adenovirus assay, hospitals will be better prepared to identify the underlying pathogens causing upper respiratory tract infections.”

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BioFire Received FDA Clearance for Updated FilmArray® Respiratory Panel Improving Sensitivity and Reactivity of Adenovirus Detection