BioFire Diagnostics has submitted 510(k) application to the US Food and Drug Administration (FDA) seeking clearance for its FilmArray gastrointestinal (GI) panel, a comprehensive 23-target system that tests for common bacteria, viruses and parasites that cause infectious diarrhoea.
The submission follows the successful completion of a clinical study that included more than 1,500 prospective samples.
The study was conducted at several hospital-based clinical laboratories in the US.
Current diagnostic practice requires choosing amongst multiple tests that can be difficult to perform and do not cover the entire breadth of pathogens that cause gastrointestinal illness.
These tests are often carried out in steps, and the process can take too long to aid in timely pathogen-specific treatment decisions.
Unlike open-platform testing that leaves labs vulnerable to cross-contamination, the FilmArray is a closed-system that integrates sample preparation, amplification and detection and the test is performed in around an hour directly from stool sample in transport media.
BioFire Diagnostics CEO Randy Rasmussen said: "This submission highlights our continued work to expand the menu of tests for our FilmArray platform."
The company expects to launch the GI panel in the second half of 2014 in both the US and Europe, pending clearances.
BioFire currently offers the FDA-cleared and CE IVD marked FilmArray respiratory panel and FilmArray blood culture identification panel.
In addition to this, the company has started studies for its Meningitis Panel, with FDA submission expected in 2015.
An estimated 76 million cases of food-borne disease occur each year in the US, resulting in 325,000 hospitalisations and 5,000 deaths.
According to GlobalData estimates, the US infectious immunology market was valued at $2.35bn in 2012 and is expected to grow at a CAGR of 5.8% to reach $3.48bn by 2019.
Image: Infectious gastroenteritis still remains a significant problem in industrialised countries among all age groups. Photo: courtesy of freedigitalphotos.net.