Multiple Independent Studies Presented at 28th Annual Clinical Virology Symposium
Gastrointestinal Panel Demonstrates Ability to Identify Viral Pathogens
SALT LAKE CITY, April 25, 2012 (GLOBE NEWSWIRE) -- Idaho Technology, Inc., a privately held clinical diagnostics company dedicated to providing the world's fastest, highest-quality instruments for pathogen identification and DNA analysis, today 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, held April 22 - 25, 2012, in Daytona Beach, FL. 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 hands-on 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 parainfluenza 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.
About FilmArray RP
FilmArray RP is Idaho Technology's first clinical diagnostic test designed to run on the Company's novel FilmArray system, which represents a significant advancement in user-friendliness and multiplex infectious disease testing capability for hospital clinical labs. FilmArray RP rapidly detects nucleic acids in nasopharyngeal swabs obtained from individuals suspected of respiratory tract infections. Requiring only two minutes of hands-on time, FilmArray RP has about a 1-hour turnaround time, and simultaneously tests for the following panel of respiratory pathogens: Adenovirus, Coronavirus HKU1, Coronavirus 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. FilmArray RP is available for use by hospital and clinical laboratory professionals in the United States and Europe, and has received FDA-clearance for a panel of the above 15 targets and CE IVD registration for a panel of 21 targets. An expanded respiratory panel, which will include five additional bacterial and viral targets, is currently under review by the FDA. Idaho Technology is continuing to develop a broader test menu for its FilmArray system, including a blood culture ID panel, gastrointestinal panel, and an STD panel.
About Idaho Technology, Inc.
Idaho Technology, Inc. is a privately held clinical diagnostics company based in Salt Lake City, Utah. Founded in 1990, the Company currently holds over 70 patents related to polymerase chain reaction (PCR), including rapid PCR cycling. The Company has used its extensive patent portfolio to successfully market nearly 200 products to the clinical, research and military markets. The Company manufactures and distributes its proprietary diagnostic respiratory panel, FilmArray RP, which operates on its user-friendly FilmArray system, to hospital-based clinical laboratories in the U.S. and E.U. The Company also collaborates with various U.S. governmental agencies including the Department of Health and Human Services, the Department of Defense and the Food and Drug Administration. Among others, researchers, medical technicians, law enforcement officers, and soldiers in the field use company devices to detect or study disease-causing organisms. For further information, please visit www.idahotech.com.