Prospective Clinical Evaluation of the FilmArray® Lower Respiratory Tract Infection (LRTI) Panel

BioFire Diagnostics, LLC (BioFire; a bioMerieux company), has developed a polymerase chain
reaction (PCR), high-resolution melting analysis instrument called the FilmArray. The
FilmArray Lower Respiratory Tract Infection (LRTI) Panel is a test designed for use with the
FilmArray that identifies common bacterial, viral, and fungal microorganisms as well as
antimicrobial resistance gene targets associated with lower respiratory tract infections. The
FilmArray LRTI Panel also provides quantitation for some bacterial analytes.

Clinical performance evaluations will be initiated at a minimum of three sites to determine
the clinical performance of the FilmArray LRTI Panel for each of the analytes on the panel
when testing bronchoalveolar lavage (BAL, including mini-BAL) and sputum (including
endotracheal aspirates) specimens from subjects with suspected lower respiratory tract (LRT)
infections. The intention is for these performance data to support regulatory classifications
of the FilmArray LRTI Panel as an in vitro diagnostic device in the US, European Union (EU),
Canada, and other regions. The study sites selected will have expertise in the diagnosis of
LRTIs, and will be able to conduct the evaluation in accordance with this protocol and Good
Clinical Practices (GCP). Prior to performing the prospective clinical evaluation, each
participating site will have the necessary Institutional Review Board (IRB) or Ethics
Committee (EC) reviews.

Specimens for inclusion in this study will be residual, de-identified BAL or sputum specimens
leftover from clinician-ordered lower respiratory pathogen testing.

Comparator testing will be performed using de-identified specimen aliquots at a central
reference laboratory and at BioFire.

This study is funded by BioFire Diagnostics, LLC.

Inclusion Criteria:

- Specimen is residual LRT specimen (sputum, ETA, BAL, or mini-BAL) that was submitted
under clinician order for standard care LRT testing

- Specimen has not been centrifuged

- Specimen has not been pre-treated

- Specimen has at least 1.5 mL of residual volume

- Specimen was collected from a subject not already enrolled in the study

- Specimen is fresh (stored at ~4°C, not frozen) and was enrolled with 24 hours of
collection

Exclusion Criteria:

- Specimen was centrifuged, pre-treated, or is less than 1.5mL

- Specimen was collected from a subject known to have cystic fibrosis

- Specimen was collected from a subject known to have tuberculosis

- Specimen was collected from a subject that was previously enrolled in the study

- Specimen has been stored for longer than 24 hours, or was frozen, or stored at room
temperature for longer than 4 hours.