Idaho Technology said this week that it has begun clinical trials of its FilmArray Respiratory Panel at three US hospital labs.
The FilmArray RP is a multiplex PCR platform that detects 21 common respiratory viruses and bacteria. The company claims that the system requires only five minutes of hands-on time and reports results in less than an hour.
The trials will be conducted at the University of Texas Southwestern Medical Center, Detroit Medical Center, and the Medical University of South Carolina.
The study will test nasopharyngeal swab specimens from 1,000 patients. Investigators will compare results from the FilmArray test to results from conventional platforms, like viral culture and antibody tests, as well as to results from other molecular diagnostic technologies.
The company said that after the trial it plans to submit a 510(k) application to the US Food and Drug Administration for use of the FilmArray RP as an in vitro diagnostic product for patients with symptoms of upper respiratory tract infection.
"Beginning these clinical trials represents a significant milestone in the development of the FilmArray, which we anticipate will soon become ITI's flagship technology," Kirk Ririe, CEO of Idaho Technology, said in a statement.
In December, the company was awarded a $3.3 million grant from the US Defense Threat Agency to help it develop the FilmArray platform [PCR Insider 12/3/2009].
The company said at the time that it planned to use the grant to pursue a Clinical Laboratory Improvement Amendments waiver from the FDA that will enable the system to be used in non-CLIA labs by operators without technical training.
Philip Maggi, vice president of external affairs at Idaho Technology, told PCR Insider at the time that the company was seeking the CLIA waiver concurrent with FDA clearance of the respiratory panel.
"Though the FDA trial and CLIA waiver study are occurring simultaneously, the CLIA waiver certification will occur after the system is FDA cleared," Maggi said in December.