SALT LAKE CITY, UT - 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 userfriendliness 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.
About Idaho Technology
Idaho Technology, Inc. is a privately held biotechnology company based in Salt Lake City, Utah. Founded in 1990, Idaho Technology licensed rapid PCR technology from the University of Utah. Through funds from the United States Department of Health and Human Services and the Department of Defense, the company has created many commercial instruments and reagents for use in research and applied fields. Several of these products, including the LightCycler® Instrument, have been sublicensed to Roche Diagnostics. Researchers, medical technicians, law enforcement officers, and soldiers in the field use the company's devices to detect or study disease-causing organisms. For further information, please visit www.idahotech.com.