BioFire Submits FilmArray® Torch to FDA for Clearance to Use with FilmArray® Respiratory Panel
Cost-effective medical device design has allowed BioFire Diagnostics to develop a family of diagnostic products which will be able to fully integrate and scale to meet the needs of hospital laboratories of any size. BioFire, a division of bioMerieux, has announced that it has submitted the FilmArray® Torch to the FDA for a special 510(k) clearance for use with the FilmArray® Respiratory Panel, another one of their diagnostic medical products.
“The Torch will fully integrate with the existing panel.”
Marcy L’Etoile of Business Wire reported that the Torch, “the latest advancement in syndromic infectious disease molecular testing,” provides up to six times more sample throughput per square foot of benchtop space. L’Etoile added that the Torch is a “fully integrated, random and continuous access multiplex PCR2 system, designed to meet the throughput demands of any size hospital laboratory.” With 510(k) clearance, the Torch will be able to fully integrate with the existing panel to provide improved diagnostic solutions.
The FilmArray® Torch is scalable to suit a laboratory’s needs: its two module base can test up to 42 patients samples per day. The 12-module, fully configured model can test up to 262 samples per day. Its designed to be compatible with any FilmArray® panel. In addition to adapting to laboratories of any size, the FilmArray® system can be set up in as little as two minutes, according to the BioFire website. This makes FilmArray® more streamlined and user-friendly than other diagnostic panels.
BioFire announced it will be submitting its other FDA-cleared FilmArray® medical products for 510(k) clearance with the Torch system. In a recent statement, BioFire CEO Randy Rasmussen said the submission shows the company’s continuing efforts to “provide our customers with the most innovative molecular infectious disease diagnostic solutions.” Please visit the BioFire website for more product information.