FDA clears ITI's FilmArray RP assay for respiratory virus detection

Idaho Technology, Inc. (ITI) announced today that the U.S. Food and Drug Administration has issued a 510(k) clearance for the FilmArray instrument and the FilmArray Respiratory Panel. The FilmArray Respiratory Panel (RP) is a multiplexed nucleic acid test designed for the simultaneous detection of 15 respiratory viruses in 1 hour.

The FilmArray RP detects viral nucleic acids in nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. The FilmArray system represents a significant advancement in user friendliness and multiplex infectious disease testing capability for hospital clinical labs. The FilmArray requires only two minutes of hands-on time, has a 1 hour turnaround time, and simultaneously tests for the following virus types and subtypes:

Adenovirus, Coronavirus HKU1, Cornonavirus NL63, Human Metapneumovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype H1 2009, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus and Respiratory Syncytial Virus

Kirk Ririe, CEO, said, "Obtaining FDA clearance on the FilmArray system is a major step toward our goal to fill the unmet need for user-friendly multiplex PCR in the hospital clinical laboratory. We continue to see a tremendous degree of interest in the FilmArray system. Many hospital clinical labs that may have avoided molecular testing in the past see the FilmArray RP assay as an easy way to bring molecular diagnostic testing online in their institutions." Ririe also noted that the company has additional FilmArray infectious disease applications in its R&D pipeline, including a blood culture ID panel, gastrointestinal panel and an STI panel.

Source: Idaho Technology, Inc.