US-based BioFire Diagnostics has begun clinical and analytical studies to evaluate its FilmArray Gastrointestinal (GI) Panel.
This clinical study is being conducted at several hospital-based clinical laboratories in the US and is funded by an NIH R01 grant.
The company intends to seek both CE IVD marking and US FDA approval for the panel.
The 23-target panel tests for common bacteria, viruses and protozoa that cause infectious diarrhea.
This test, which takes approximately an hour, is done directly from stool in transport media.
BioFire CEO Kirk Ririe noted that with the commencement of GI studies, the company continues to expand its FilmArray clinical diagnostic test menu.
"We are expecting very encouraging results, and our continued advancement in diagnostic testing is a reflection of BioFire’s passion for creating breakthrough solutions that improve health and advance science," Ririe added.
BioFire intends to introduce the GI panel in the second half of 2014 in the US and Europe.
The panel will be the third clinical diagnostic test to run on the FilmArray system.