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FilmArray® Diagnostic Platform Shows Workflow Benefit and Pathogen Specificity

Multiple Independent Studies Presented at 28th Annual Clinical Virology Symposium Gastrointestinal Panel Demonstrates Ability to Identify Viral Pathogens.Idaho Technology, Inc., have announced the presentation of several posters highlighting the Company´s diagnostic FilmArray® Respiratory Panel (FilmArray RP), a user-friendly multiplex pathogen detection system that simultaneously tests for 15 different pathogens, at the 28th Annual Clinical Virology Symposium and Annual Meeting of the Pan American Society for Clinical Virology. FilmArray RP was FDA-cleared and launched nearly one year ago in the United States and recently received CE Mark for commercialization in Europe.

At the Symposium, researchers from several hospital-based clinical laboratories presented data highlighting the benefits of the panel. In these studies, FilmArray RP was shown to reduce sample turnaround time and improve workflow significantly compared to commercial real-time PCR systems and laboratory-developed real-time PCR assays. One study concluded that a single FilmArray RP sample required an average of only four minutes of handson time, with a turnaround time of 65 minutes. A separate study by a different group showed similar results, demonstrating that up to seven clinical samples could be analyzed using a single FilmArray instrument during a typical eight-hour shift. These studies demonstrate the unique power of FilmArray RP to provide meaningful clinical information in situations where a rapid result can impact patient care.

Over 2,000 clinical samples were examined in another study, the results of which confirmed FilmArray RP´s high specificity for human para influenza virus type 4 (HPIV4), a rarely reported causative agent for upper respiratory tract infections. Further testing of positive samples in this study revealed that the cases had not been the result of a single outbreak, and provided additional evidence that HPIV4 may be a more prevalent pathogen in immune compromised patients, highlighting the importance of FilmArray RP as a broadly effective surveillance tool. Additional studies also indicated FilmArray RP´s high level of specificity for the 15 pathogens it detects, reaching 100% specificity and surpassing that of other respiratory virus panels available today.

Finally, Idaho Technology presented a poster demonstrating the ability of its development-stage FilmArray gastrointestinal panel (FilmArray GI) to detect multiple viral pathogens in unprocessed stool samples. In the study, FilmArray GI successfully detected many of these, both in clinical isolates and in samples collected from actual patients. Detection of each virus was shown to be specific and no cross-reactivity with other pathogens included in the panel was observed. Rapid, accurate diagnosis of enteric viruses using FilmArray GI has the potential to improve outbreak control drastically and decrease mortality and morbidity associated with viral GI infections.

Idaho Technology expects to begin beta testing FilmArray GI in select hospital labs this summer. Based on those results, the Company will begin clinical studies in support of FDA 510(k)-clearance.

 

     
Tags: Influenza, Respiratory Virus, PCR, Pathogen, FDA

Date Published: May 8, 2012

Source article link: BioFire Diagnostics, Inc.
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