Idaho Technology receives FDA 510(k) clearance for rapid respiratory pathogen detection system
28 May 2012
Idaho Technology, Inc. has announced US FDA 510(k) clearance of five additional pathogens for its FilmArray Respiratory Panel (FilmArray RP), a user-friendly multiplex pathogen detection system. FilmArray RP is now FDA-cleared for 20 viral and bacterial respiratory pathogens.
“We are pleased to offer a more robust and simpler way to test for upper respiratory tract infections,” said Kirk Ririe, Chief Executive Officer of Idaho Technology. “Gaining clearance of these additional pathogens for FilmArray RP is an accomplishment long-anticipated by our users in the hospital clinical laboratory community because it improves laboratory testing capacity while providing the fastest way to better results.”
With the addition of these five pathogens, the FilmArray RP now includes the first FDA cleared assays for 8 of the 20 organisms on the panel. Furthermore, the FilmArray RP is the only FDA-cleared panel capable of distinguishing between certain bacterial and viral respiratory infections. This represents a significant advancement in the field of infectious disease detection, with the potential to provide clinical laboratories and physicians with more comprehensive, actionable information to guide treatment decisions and improve patient outcomes.
The additional five pathogens are; Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Coronavirus 229E, and Coronavirus OC43. Bordetella pertussis outbreaks in recent months have highlighted the need for an FDA-cleared test that can rapidly and accurately distinguish viral infections from more serious bacterial illness.
Mr. Ririe Continued, “Our expanded respiratory panel highlights the diagnostic potential of our dynamic and innovative FilmArray platform. After almost one year on the market with FilmArray RP, we have been very encouraged by the market acceptance we’ve received. We expect, based on current demand for our product and our growing pipeline of additional clinical diagnostic tests, to establish a leadership position in clinical diagnostics, building upon our legacy and expertise in pathogen identification.”
Idaho Technology is currently developing additional applications for their FilmArray system including a blood culture ID panel, gastrointestinal pathogens panel, and an STD panel. The Company expects to begin clinical testing its blood culture ID panel later this year.
Launch in Europe
In April, the company announced the European launch of (FilmArray RP. 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 EU 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.
"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."
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, 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.