Diagnostics firm Qvella has obtained a CE mark for its Field Activated Sample Treatment (FAST) System and FAST-PBC Prep Cartridge products to be used for in vitro diagnostic (IVD) in Europe.
The products have also been listed as Class I IVD devices by the US Food and Drug Administration (FDA).
The company’s FAST-Technology eliminates the need for time-consuming culture methods, facilitates automation and accelerates different microbiology workflow stages to generate information for bloodstream infections.
It uses a new sample treatment method that enables the rapid isolation and concentration of bacterial cells in clinical specimens.
During the recent beta trials of the FAST System and FAST-PBC Prep Cartridge, Qvella’s fully automated FAST-Technology showed easy integration into existing workflows and required hands-on time of approximately two minutes.
The trials were conducted at healthcare centres in the US and Europe.
The FAST System isolates and concentrates pathogens to produce a liquid colony (LC) that can be used for downstream workflows, such as ID by MALDI-TOF and AST by automated systems that include bioMérieux VITEK2, BD Phoenix, Disc Diffusion and Beckman Coulter MicroScan WalkAway.
After obtaining a positive blood culture (PBC), the LC can be generated immediately, potentially saving 24 hours or more during the diagnosis of infections.
Qvella president, CEO and co-founder Tino Alavie said: “With several performance evaluation studies completed and EU and USA marketing authorisation granted, we have officially reached the commercialisation milestone for our FAST System.
“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 commercialisation 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.”
Compared to other rapid technologies, Qvella’s solution is claimed to be relatively cost-effective.