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Idaho Tech Preparing for Regulatory Clearance, Launch of Blood Culture ID, GI Panels

NEW YORK (GenomeWeb News) – Idaho Technology today said that it anticipates commercially launching its blood culture ID and gastrointestinal panels by early 2014.

In an update on the company's clinical pipeline, Idaho Technology CEO Kirk Ririe said that clinical trials for the BCID panel have begun while the clinical evaluation of the GI panel is expected to launch in the first quarter of 2013.

"Pending regulatory clearance," he said in a statement, "we expect the BCID panel to be available commercially in the US and Europe in the first half of 2013 and the GI panel to follow early in 2014."

Both tests are built on the Salt Lake City-based company's FilmArray system, a PCR-based platform. The FilmArray BCID test identifies sepsis-causing organisms as well as the presence of antibiotic-resistance genes. Idaho Tech said the test is designed to detect about 90 percent of the pathogens isolated from positive aerobic blood cultures, and preliminary results showed it had "good concordance" with the gold standard of culture and biochemical identification.

The current version of FilmArray BCID simultaneously tests for eight gram-positive and 11 gram-negative bacteria, five yeast pathogens, and four antibiotic resistance genes, the company said. Clinical trials are underway to obtain US Food and Drug Administration clearance and CE IVD marking.

The FilmArray GI panel is for identifying GI pathogens from stool samples that have been minimally processed. The current version of the panel simultaneously detects 25 different diarrheagenic pathogens, including bacteria, viruses, and protozoa. An early phase study has demonstrated good concordance between the FilmArray GI and standard clinical testing, Idaho Tech said.

It added that because the test detects several pathogens from a single sample, it can identify "significantly" more pathogens than individual tests ordered by physicians. A second early phase test for FilmArray GI for the detection of Clostridium difficile also demonstrated good concordance between the test and an FDA-cleared molecular assay, the company said.