BioFire Diagnostics, LLC

BioFire Diagnostics offers syndromic infectious disease diagnostic solutions with several assay-specific reagent panels. Each panel provides the ability to detect and identify a broad grouping of probable pathogens in a single, rapid PCR-based test. The syndromic approach maximizes the chances of finding out what's making a patient sick. Fast and accurate diagnostic results help physicians quickly provide appropriate treatment.

The BioFire® Respiratory 2.1-EZ (RP2.1-EZ) Panel (EUA)* identifies SARS-CoV-2 in patients suspected of COVID-19, along with 18 additional respiratory pathogens, with results in about 45 minutes. The BioFire RP2.1-EZ Panel (EUA) is intended to be run on the BioFire® FilmArray® 2.0 EZ Configuration, which facilitates rapid, near-patient testing.

The following panels are intended for use with the BioFire® FilmArray® Torch or the BioFire® FilmArray® 2.0 systems:

The BioFire® Respiratory 2.1 Panel identifies 22 common respiratory bacteria and viruses, including SARS-CoV-2, with results in about 45 minutes.

The BioFire® FilmArray® Gastrointestinal Panel tests for 22 common gastrointestinal pathogens, including bacteria, viruses, and parasites, with results in about an hour.

The BioFire® Blood Culture Identification 2 Panel identifies 43 targets associated with bloodstream infections, including gram-negative bacteria, gram-positive bacteria, yeast, and 10 antimicrobial resistance genes, with results in about an hour.

The BioFire® FilmArray® Meningitis/Encephalitis Panel tests for 14 of the most common bacterial, viral, and fungal pathogens associated with central nervous system (CNS) infections in about one hour.

The BioFire® FilmArray® Pneumonia (PN) Panel identifies 33 clinically relevant targets from sputum (including endotracheal aspirate) and bronchoalveolar lavage (including mini-BAL) samples. The BioFire PN Panel provides semi-quantitative results for 15 of the bacteria, which may help determine if an organism is a colonizer.

For more information about the BioFire® FilmArray® Panels, visit biofiredx.com.

*This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by authorized laboratories; this test has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms; and this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.