The FilmArray RP includes integrated sample preparation. It requires only five minutes of hands-on time and reports results in less than an hour, claims the company.
The company said that clinical trials will be conducted at Children’s Medical Center, in association with UT Southwestern Medical Center, Dallas Texas, Detroit Medical Center, Detroit, Michigan, and The Medical University of South Carolina, Charleston, South Carolina.
Kirk Ririe, CEO of Idaho Technology, said: “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 molecular diagnostic assay designed for comprehensive detection of common respiratory pathogens and yet is still incredibly simple and easy to use. Beginning these clinical trials represents a significant milestone in the development of the FilmArray which we anticipate will soon become ITI’s flagship technology.”
Beth Lingenfelter, director of regulatory affairs, said: “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.
“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.”
