Jan 27 2010
Idaho Technology, Inc. (ITI) announced today that clinical trials of the
FilmArray Respiratory Panel (RP) have commenced at three US Hospital
Laboratories.
“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”
“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.