NEW YORK – Diagnostics company Qvella announced on Friday that it has obtained the CE mark for its FAST System and FAST-PBC Prep Cartridge products to process positive blood cultures for sepsis testing. The products have also been listed as Class I in vitro diagnostic devices with the US Food and Drug Administration.
The system and prep cartridge are fully automated technologies to enable rapid isolation and concentration of bacterial cells in clinical specimens. They require hands-on time of two minutes and integrate into existing workflows to allow processing for downstream applications up to 24 hours sooner than current methods, Qvella said in a statement.
The FAST System isolates and concentrates pathogens to generate a so-called liquid colony which can be used for downstream workflows such as bacterial identification by MALDI-TOF or antimicrobial susceptibility testing by automated systems. The liquid colony can be generated immediately after obtaining a positive blood culture, potentially allowing for the diagnosis of infections more than 24 hours sooner than with current methods, Qvella said. The solution is also cost effective compared to molecular blood culture identification panels, the firm added.
Users are responsible for validating the FAST System and FAST-PBC Prep Cartridge in combination with their lab's diagnostic procedures and in accordance with applicable regulations, the Richmond Hill, Ontario-based firm noted.
"With several performance evaluation studies completed and EU and US marketing authorization granted, we have officially reached the commercialization milestone for our FAST System," said Tino Alavie, president, CEO, and cofounder 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," Alavie added.
Concurrent with the marketing authorization and commercialization of the FAST System and FAST-PBC Prep Cartridge, the results of a completed study of the technology were published in the Journal of Clinical Microbiology earlier this month. The firm will also present the technology in two sessions at the European Congress of Clinical Microbiology & Infectious Diseases next week.