BioFire Earns FDA Clearance for Updated Respiratory Panel

BioFire Diagnostics, Inc., has received FDA clearance of its updated FilmArray respiratory panel, which is designed to improve the detection of adenovirus. Studies of the modified panel demonstrated a 73-percent increase in the detection of Adenovirus and a threefold 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.          



“We are pleased that the updated FilmArray RP has received FDA clearance,” said Kirk Ririe, chief executive officer of BioFire Diagnostics. “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.”