Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study

BioFire Diagnostics, LLC (BioFire) has developed the FilmArray Gastrointestinal (GI) Panel, a
rapid, easy to use PCR-based in vitro diagnostic test for the identification of 22 common
microorganisms responsible for infectious gastroenteritis (http://filmarray.com/the-panels/)
from a stool specimen collected in Cary Blair enteric transport media. The test was made
available for sale in the US and EU following FDA clearance and CE marking in May, 2014.

The FilmArray GI Panel offers improvements over conventional laboratory testing which
include: reduced turnaround time from specimen to result, reduced laboratory labor costs,
increased sensitivity and specificity relative to current clinical reference methods, and
larger breadth of organism identification than is available using standard methods. Because
of these attributes, the results from this test have the potential to enable clinicians to
more accurately diagnose and treat GI illness in a reduced time frame.

Collaborators at the University of Utah, Brown University/Lifespan, and BioFire Diagnostics
have designed a study to evaluate health outcomes of pediatric subjects presenting to
emergency departments with GI illness before and after establishing the FilmArray GI Panel as
the standard of care method for stool pathogen analysis. It is hypothesized that the rapid (~
1 hour turnaround time), sensitive, specific, and comprehensive results provided by the
FilmArray GI Panel will allow clinicians to more rapidly diagnose GI illness, initiate
appropriate therapy and provide guidance when compared to the pre-implementation period.