Qvella FAST System and FAST-PBC Prep Cartridge Get CE Marked and FDA Listed for In Vitro Diagnostic Use

Qvella, a diagnostics company that aims to reduce 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 for 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.”

Study Published in Journal of Clinical Microbiology
Concurrent with the marketing authorization and commercialization of the FAST System and FAST-PBC Prep Cartridge, the results of a completed study have been published in the latest Journal of Clinical Microbiology in an article titled “Saving Time in Blood Culture Diagnostics: a Prospective Evaluation of the Qvella FAST-PBC Prep Application on the FAST System.”

Qvella at ECCMID
At the 32^nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) taking place in Lisbon, Portugal and online from April 23 – 26, 2022, Qvella’s FAST System and FAST-PBC Prep Cartridge are the subjects of two presentations.

• April 24, 2022, at 11:30 WEST, Product Theatre Pavilion 3
  Prof./Dr. Alexandre Dalpke, Dept. of Medical Microbiology and Hygiene, University of Heidelberg, Germany will be presenting details on the study published in the Journal of Microbiology. His presentation is titled: “Saving time in microbiological blood culture diagnostics: Evaluation of Qvella’s FAST system for accelerated identification and antimicrobial susceptibility testing”

• April 25, 2022, at 14:00 WEST, Product Theatre Pavilion 3
  Alberto Antonelli PhD, Research fellow at the University of Florence, Department of Experimental and Clinical Medicines, will be presenting on this topic: “Rapid detection of Carbapenemase-Producing Enterobacterales using a novel sample preparation method and lateral flow immunoassays from positive blood culture.”

About Qvella Corporation
Qvella is a diagnostics company founded in 2009 by a group of scientists and engineers with the goal of dramatically reducing time to results in bacteriology. The company aims to revolutionize how medicine is practiced by significantly cutting time, costs and saving lives. Qvella's FAST technology utilizes a novel sample treatment technique that enables the rapid isolation and concentration of bacterial cells in clinical specimens. When implemented in concert with a variety of downstream applications and detection methodologies, it can significantly reduce time to results. When these efforts are coupled with Antibiotic Stewardship programs, now being adopted by most major medical centers, timely clinical decisions can be made which leads to improved patient outcomes, reduced hospital stays, lower side effect profiles, and a significant reduction in treatment costs. Qvella has nearly 130 employees working from its headquarters in Richmond Hill, Ontario as well as offices in Carlsbad, California and Mechelen, Belgium. Additional information is available at qvella.com.

Disclaimers
For In Vitro Diagnostic Use. FAST™ System and FAST-PBC Prep Cartridge have not been validated for any downstream diagnostic procedures or applications and are only indicated for positive blood culture specimens containing bacteria. The user is responsible for validating the FAST™ System and FAST-PBC Prep Cartridge in combination with diagnostic procedures used in their laboratory and in accordance with applicable regulations. Products are region specific and may not be approved for sale in your jurisdiction. Contact Qvella for regulatory status and product information pertaining to your country/region.

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