Business Wire

QVELLA

Share
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 32nd 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.

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Elegen and Nutcracker Therapeutics to Pilot First Fully Cell-Free Manufacturing Process for RNA-based Personalized Cancer Therapeutics11.7.2025 14:00:00 CEST | Press release

Fully cell-free process aims to further democratize personalized cancer therapeutic manufacturing with shorter turnaround times and negligible bioburden and endotoxin risks. Elegen, a global leader in next-generation DNA manufacturing, and Nutcracker Therapeutics, a global leader in next-generation RNA design and manufacturing, today announced the launch of a pilot program to demonstrate the industry’s first fully synthetic, cell-free manufacturing platform for RNA-based personalized cancer therapeutics (PCTs). The pilot marks another step toward making PCTs more accessible, timely, and scalable. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250711152688/en/ As late-stage PCT clinical trials progress and therapy developers work to create the next generation of PCTs, the speed, reliability, scaling and cost of traditional production methods pose a major challenge. Specifically, the first step of DNA template production is hi

$MBG Token Pre-Sale Set for July 15 — Only 7 Million Tokens Available at $0.3511.7.2025 10:17:00 CEST | Press release

MultiBank Group, the world’s largest financial derivatives institution headquartered in Dubai, has confirmed that its highly anticipated $MBG Token pre-sale will go live on July 15, with demand expected to be intense. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250711737311/en/ With only 7 million $MBG tokens up for grabs at an exclusive entry price of $0.35, this is a rare opportunity to secure early access to what many are calling the year’s most powerful utility asset. With only 7 million tokens up for grabs at an exclusive entry price of $0.35, this is a rare opportunity to secure early access to what many are calling the year’s most powerful utility asset. Early participants can join simultaneously on MultiBank.io, the Group’s regulated crypto exchange, and Uniswap, the world’s leading decentralized platform. Supported by $29 billion in real assets and powered by over $35 billion in daily turnover, $MBG is engineered

Live Story Raises €2.7 Million to Revolutionize the Digital Experience11.7.2025 10:05:00 CEST | Press release

With a round led by Vertis, the next-generation CMS platform accelerates its focus onAI, performance, and European expansion. Target: surpass €10M in recurring revenueby 2027. Live Story, the tech company founded by Stefano Mocellini, has closed a €2.7 million seed round led by Vertis, one of Italy’s leading early-growth venture capital firms. The funding will support the company’s international expansion and technological development, with a clear goal: to exceed €10 million in annual recurringrevenue by 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250711335560/en/ “We invested in Live Story because it addresses one of the major inefficiencies in digital commerce: the slow and rigid management of visual and narrative content,” says Alessandro Pontari, Partner at Vertis SGR. “The platform helps brands drastically reduce their time-to-market through a visual CMS that integrates seamlessly with any tech stack. In a wor

With a Score of 84 out of 100, Sagemcom Is Awarded the EcoVadis Platinum Medal: a Prestigious Recognition of its CSR Commitment11.7.2025 09:00:00 CEST | Press release

Sagemcom Group is proud to announce that it has been awarded, for the third time, the Platinum Medal by EcoVadis, the highest distinction granted by the leading global platform for assessing Corporate Social Responsibility (CSR) performance. This medal places Sagemcom in the top 1% of companies evaluated worldwide, across all industries. With a score of 84 out of 100, Sagemcom reaffirms its position as a committed leader in ecological transition, business ethics, sustainable supply chain management, and social responsibility. “The EcoVadis Platinum Medal is more than just an award — it is the recognition of our collective efforts to embed sustainable development principles at the heart of our corporate strategy and culture,” says Sylvaine Couleur, Executive Vice President, CSR & Communication. “Achieving this level demonstrates that our commitments are tangible, impactful, and internationally recognized. This distinction strengthens our determination to further advance and expand our C

IEEE Standards Commitment to Advancing AI Governance Includes Impactful Contributions to New International AI Standards Exchange11.7.2025 08:00:00 CEST | Press release

IEEE, the world’s largest technical professional organization dedicated to advancing technology for humanity, and its IEEE Standards Association (IEEE SA) announced today that its portfolio of over 100 global AI-related standards is included in the new International AI Standards Exchange. This Exchange is a centralized repository of international AI standards with the aim to foster collaboration and responsible AI development worldwide. IEEE and its AI global standards were recognized in the 2024 United Nations AI Advisory Body’s Report, Governing AI for Humanity, which created the impetus for the AI Standards Exchange. Due to its impactful AI standards and related work, IEEE, a major standards body, was included as a partner in the establishment of the Exchange. IEEE President and CEO Kathleen Kramer, who is speaking at the AI for Good Summit this year at the High-Level AI Standards Panel,shares, “IEEE’s mission of advancing technology for the benefit of humanity is foundational to ou

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye