Idaho Technology, announces new clinical diagnostic test candidates under development for their FilmArray analysis platform. Idaho Technology and their partners have appeared at the American Society for Microbiology 2012 general meeting in San Francisco to deliver preliminary evaluations of their GI gastrointestinal panels and development-stage blood culture panels (BCID).
The new products are Idaho Technology's most sophisticated clinical diagnostics test candidates which, subject to successful clinical trials, will expand FilmArray's test menu, which already features Idaho Technology's FDA-approved CE marked In Vitro Diagnostic system, the FilmArray RP respiratory panel.
Bacterial Culture Identification
Idaho Technology's CEO, Kirk Ririe, advised: "We are pleased to report these encouraging findings, which demonstrate the broad applicability of our FilmArray rapid diagnostic platform. We recently initiated clinical trials for our BCID panel and expect to launch the clinical evaluation for our GI panel in the first quarter of next year. Pending regulatory clearance, we expect the BCID panel to be available commercially in the U.S. and Europe in the first half of 2013 and the GI panel to follow early in 2014."
FilmArray BCID
Idaho Technology's BCID panel can identify the full range sepsis-causing organisms and also detect a number of genes for antibiotic resistance. The panel can effectively detect around ninety percent of all pathogens taken from positive aerobic blood cultures. Early results using residual positive blood cultures at three external locations using a test version of the panel demonstrated good agreement with the leading method in biochemical and bacterial culture identification.
The BCID panel enables fast identification of a wide range of pathogens in blood cultures. It could lead to better management of sepsis in medical applications. The latest model under development enables parallel testing for a total of eleven gram-negative and eight gram-positive bacteria, along with four genes for antibiotic resistance, and five yeast pathogens. Following positive outcomes from beta testing, clinical trials have been instigated to confirm the performance of the product and to gain both CE IVD marking and FDA approval for the panel.
Gastrointestinal Pathogen Detection
FilmArray GI
Idaho's GI pathogen detection system is designed to quickly recognise gastrointestinal pathogens by analysis of minimally prepared stool samples. The latest model of the panel under development can simultaneously recognise 25 diarrheagenic pathogens including viruses, bacteria and protozoa. In one early study the filmArray GI re-tested de-identified stool samples from standard-of-care testing.
In the initial tests, the FilmArray GI panel agreed well with the results of traditional clinical testing methods for gastrointestinal pathogen detection. Also, due to its ability to screen for multiple pathogens simultaneously, the panel can detect a number of pathogens from one sample, and can identify a significantly greater number of pathogens than can be detected by performing individual tests using the same samples. These findings underline the potential benefits of the FilmArray GI for multiplex pathogen detection. The system has shown that it can effectively recognise pathogens where pathogen-specific testing is either unavailable, or has not been requested.
Another early study examined the detection of Clostridium difficile infections with the FilmArray GI. This pathogen is the primary cause of diarrhea which has been increasing in prevalance and mortality. Again, the study showed a high level of agreement between the FilmArray GI and a FDA-approved molecular assay. In common with the earlier evaluation, the FilmArray GI panel was able to not only detect Clostridium difficile, but also recognise additional diarrheal pathogens, both in samples testing positive for C. difficile, and those testing negative. Multiplex testing devices like the FilmArray GI could therefore prove valuable for rapid and reiable diagnosis of diarrheal pathogens.
As yet, the FilmArray BCID and GI panels are not CE IVD marked or FDA approved, are not commercially available and cannot be used for in vitro dianostic procedures.
However, Mr Ririe explained "In addition to our clinical diagnostic pipeline, we continue to gain significant traction in the market with placements of our FilmArray RP only one year since its commercial launch. As a profitable clinical diagnostics company, we are committed to providing rapid, actionable results and unmatched user- friendliness to meet the needs of clinical laboratories and health care providers worldwide."
来宝会员