Idaho Technology Inc. begins FDA clinical trials for the FilmArray™ Respiratory Panel
Salt Lake City, UT — Idaho Technology, Inc. (ITI) announced today that clinical trials of the FilmArray Respiratory Panel (RP) have commenced at three US Hospital Laboratories.
“We believe that the FilmArray RP holds tremendous potential for hospital clinical laboratories
frustrated with the hassle, long turnaround times, and inferior sensitivity and specificity of viral
culture, DFA, and rapid flu tests. The FilmArray RP is a powerful molecular diagnostic assay
designed for comprehensive detection of common respiratory pathogens and yet is still incredibly
simple and easy to use,” said Kirk Ririe, CEO of Idaho Technology. “Beginning these clinical
trials represents a significant milestone in the development of the FilmArray which we anticipate
will soon become ITI’s flagship technology,” Ririe added.
The much anticipated FilmArray RP is a user-friendly multiplex PCR platform capable of detecting
21 common respiratory viruses and bacteria. The FilmArray RP includes integrated sample
preparation, requires only 5 minutes of hands on time, and reports results in less than an hour.
“For this study, we will be testing nasopharyngeal swab specimens from 1,000 patients and
comparing the results from the FilmArray Respiratory Panel to the results from conventional as
well as other molecular diagnostic technologies” commented Beth Lingenfelter, director of
regulatory affairs. “Following data collection and analysis, we intend to submit a 510k application
to the FDA for use of the FilmArray RP as an In Vitro Diagnostic product for patients with
symptoms of upper respiratory tract infection.”
The clinical trials will be conducted at Children’s Medical Center, in association with UT
Southwestern Medical Center, Dallas TX; Detroit Medical Center, Detroit, MI; and The Medical
University of South Carolina, Charleston, SC.
About Idaho Technology
Idaho Technology, Inc. is a privately held biotechnology company based in Salt Lake City,
Utah. Founded in 1990, Idaho Technology licensed the 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 diseasecausing organisms. For further information, please visit www.idahotech.com.

