Idaho Technology, Inc., a privately held biotechnology and clinical diagnostics company dedicated to providing the world's fastest, highest-quality instruments for pathogen identification and DNA analysis, today announced the European launch of its FilmArray Respiratory Panel (FilmArray RP), a multiplex clinical diagnostic product that simultaneously detects 21 respiratory pathogens in about one hour. FilmArray RP is Idaho Technology's first clinical diagnostic test designed to run on the Company's user-friendly FilmArray system. The FilmArray RP received FDA 510(k) clearance last year for a panel of 15 analytes and recently achieved CE in vitro diagnostic (IVD) registration in the E.U. for a panel of 21 analytes.
The Company also announced that it is partnering with the DiaMondiaL family of distributors in strategic territories throughout Europe. Each of these partners is well recognized as a leading supplier of laboratory instruments and testing services, and will now add FilmArray RP to their product offerings.
The product is being showcased at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), held March 31 -- April 3, 2012, at ExCeL London, London, UK (Booth 567).
"Launching FilmArray RP in Europe represents a significant milestone for our clinical diagnostics business," said Kirk Ririe, Chief Executive Officer of Idaho Technology. "Along with our esteemed distribution partners, we are pleased to offer our user-friendly multiplex pathogen detection system to the broad community of clinical laboratory professionals. Our FilmArray system is capable of testing for a comprehensive panel of viral and bacterial pathogens in about one hour, while offering the user only two minutes of hands-on time, with no precise measuring or pipetting required. We believe this represents a significant advancement in the field of infectious disease detection, with the potential to improve the testing capacity of hospital clinical laboratories worldwide."
Since launching in the U.S., FilmArray RP has experienced rapid adoption by the clinical laboratory community. In January 2012, Idaho Technology filed a submission with the FDA to clear five additional respiratory pathogens in an expanded panel for use on the FilmArray system. The Company expects to receive FDA clearance for the expanded panel in the second quarter of 2012. Idaho Technology is continuing to develop a broader test menu for its FilmArray system, including a blood culture ID panel, gastrointestinal panel, and an STI panel.
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, Bocavirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, 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, Respiratory Syncytial Virus, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumonia. FilmArray RP has received FDA-clearance for a panel of 15 of these targets and CE IVD registration for a panel of all 21 targets. The FilmArray is available for use by hospital and clinical laboratory professionals in the United States and Europe.