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BioFire Submits 510(k) for High Throughput FilmArray Torch, Respiratory Panel

NEW YORK (GenomeWeb) – BioMérieux subsidiary BioFire Diagnostics announced today it has submitted its FilmArray Torch platform for special 510(k) clearance to the US Food and Drug Administration.

The firm will seek device modification for the high throughput platform for use with the FilmArray Respiratory Panel (RP).

The Torch platform is an integrated, random and continuous access system for syndromic infectious disease molecular testing, BioFire noted in a statement. It consists of scalable modules, the firm said — a two-module system would be able to test 42 patient samples per day, while a 12-module system would be capable of testing up to 262 patient samples per day.

"This submission highlights our continued effort to provide our customers with the most innovative molecular infectious disease diagnostic solutions," BioFire CEO Randy Rasmussen said in the statement.

Like the standard FilmArray platform, Torch will integrate sample preparation, amplification, and pathogen detection in a closed multiplex PCR reaction requiring two minutes of hands-on time and an hour run time. The FilmArray RP, meanwhile, is a panel of 20 respiratory viruses and bacteria performed on nasopharyngeal swab samples.

The firm also announced it will submit its other existing FDA-cleared FilmArray panels for 510(k) with the high throughput Torch system.

BioFire's Blood Culture Identification sepsis panel was initially cleared in 2013, while its gastrointestinal panel for detecting bacteria, viruses, and parasites that can cause infectious diarrhea cleared the following year, and a panel to detect pathogens causing meningitis and encephalitis cleared this past October. The respiratory panel was initially granted 510(k) clearance in 2011, when BioFire Diagnostics was still named Idaho Technology. BioMérieux acquired BioFire Diagnostics in early 2014 for a total price of $486 million.

The global installed base in clinical labs of FilmArray was about 2,000 systems at the end of September, 2015, while revenue nearly doubled, "underscoring the rapid adoption of syndromic infectious disease testing in the US," the firm said in the statement.