Qvella FAST System and FAST-PBC get CE marked and USFDA listed

With the commercialization of Qvella technology for Positive Blood Culture (PBC) processing, healthcare facilities can now get results up to 24 hours faster than current methods

Qvella, a diagnostics company that aims to reduce the time to results in bacteriology, today announced the commercialization of its FAST System and FAST-PBC Prep Cartridge product for Positive Blood Culture (PBC) processing. The products have received CE marking for in vitro diagnostic (IVD) use in Europe and are now listed as Class I IVD devices with the FDA for the U.S. market.

Qvella's patented FAST-Technology (Field Activated Sample Treatment) eliminates the need for time-consuming culture methods. This allows the processing of downstream applications up to 24 hours faster than current methods so lifesaving treatment, for example, could be started much more quickly than ever before. This disruptive technology can change outcomes for patients, while simultaneously saving money for healthcare providers.

During recent beta trials of Qvella’s FAST System and FAST-PBC Prep Cartridge at renowned healthcare centers in the U.S. and Europe, the research labs noted that Qvella’s technology easily integrates with existing workflows and the fully automated solution requires a minimal hands-on time of approximately two minutes. The FAST System isolates and concentrates pathogens to generate a Liquid Colony (LC) which can be readily used to set up a variety of downstream workflows, including ID by MALDI-TOF, and AST by automated systems such as BD Phoenix, bioMérieux VITEK 2, Beckman Coulter MicroScan WalkAway, Disc Diffusion, and others. The resulting LC very closely match the standard of care. The LC can be generated immediately after obtaining a PBC, potentially saving 24 hours or more in diagnosis of infections. The trials also noted that Qvella’s solution is relatively inexpensive in comparison to other rapid technologies.

“With several performance evaluation studies completed and EU and USA marketing authorization granted, we have officially reached the commercialization milestone for our FAST System,” said Tino Alavie, president, CEO, and co-founder of Qvella. “Given the shortage of technicians that healthcare systems are seeing right now amid the COVID-19 pandemic, the timing could not be better for the commercialization of our technology. It can be used to accelerate infection identification, for example, or to accelerate antibiotic susceptibility testing, with results delivered 24 hours earlier than previously possible. It is also very cost effective compared to molecular blood culture identification panels.”