CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Anne Ford
January 2014—Fewer children with respiratory disease symptoms hospitalized from the ED without a diagnosis, less antibiotic use, and a favorable ratio of reimbursement to expense. That’s what the laboratory at Children’s Healthcare of Atlanta is seeing, said Beverly B. Rogers, MD, chief of pathology, in a Nov. 5 webinar, “Focus on FilmArray: One New Technology Applied to Classic Clinical Problems.” Presented by CAP TODAY and made possible by an educational grant from BioFire Diagnostics, the webinar centered on the multiplex PCR system from BioFire that tests for viruses, bacteria, yeast, and antimicrobial resistance genes.
Stevenson
BioFire marketing director Wade Stevenson explained how FilmArray works. “It does sample prep, it does amplification, and it does detection” in one benchtop instrument, he said, adding that “it is capable of testing for dozens of targets, all in one reaction.” The user injects water into the FilmArray’s reagent storage device, then injects the sample and loads the instrument. At that point, the FilmArray performs the sample extraction and preparation, extracting and purifying total nucleic acids before delivering those acids first to a multiplex PCR chamber and then to a PCR array.
The Food and Drug Administration has cleared two panels for Film-Array: respiratory and blood culture identification. “We’re real excited,” Stevenson said. “We just finished our clinical trial for our gastrointestinal panel. We’re writing up the 510k submission now.” At BioFire, the hope is to have FDA clearance for the GI panel by mid-2014. “And then deeper in our pipeline, we have a meningitis panel for which we’re just now ramping up to begin clinical trials,” early in 2014, “and then [even] deeper in our pipeline, a lower respiratory panel.”