Business Wire

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

Share

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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media
Jodi Echakowitz
Boulevard Public Relations
416-271-7250
jodi@boulevardpr.com

About Business Wire

Business Wire
Business Wire



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

Align Announces Additional Leadership for UK and EMEA to Support Continued Growth18.5.2022 17:11:00 CEST | Press release

Align, the premier global provider of technology infrastructure solutions celebrates significant growth throughout the UK and EMEA markets with management changes to support increasing demand. The appointment of Giulia Marcolina as Managing Director and Mike Konold as AV Solutions Director of Align’s UK-based headquarters, will enable the team to deliver innovative collaborative technology and state-of-the-art AV solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220518005833/en/ Giulia Marcolina, a 15 year veteran with Align, is named Managing Director of Align's UK-based headquarters. (Photo: Business Wire) Giulia brings over 25 years of IT experience, previously serving as Align’s Programme Manager, delivering corporate office relocation and consolidation projects for clients such as Blackrock, Total Gas and Power, and UBS. In her new role, she will lead Align’s team of project managers in building upon Align’s lon

RMS Advances Climate Risk Modeling and Moves More Models to High Definition18.5.2022 16:30:00 CEST | Press release

RMS®, a Moody’s Analytics company and world-leading risk modeling and solutions company, today announces it will be releasing four new High Definition™ (HD) models, including Europe Windstorm, North America Winterstorm (WT), North America Severe Convective Storm (SCS), and Terrorism. RMS HD Models represent the next generation of risk modeling, delivering deeper analysis and granularity from Moody’s. The HD probabilistic models incorporate a high-fidelity, simulation-based framework for modeling event frequency and severity, to provide a major step forward in the quality of catastrophe risk quantification. The framework allows for event footprints to be represented more realistically across larger event sets. The new RMS Europe Windstorm HD Model further enhances the current model and will cover 17 countries, adding Finland and Lichtenstein. The HD model includes a climate variability view and has expanded storm surge analytics to include the U.K., Ireland, France, and Belgium. Storm c

Suketu Upadhyay Elected to Vertex Board of Directors18.5.2022 16:30:00 CEST | Press release

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Suketu (“Suky”) Upadhyayhas been elected to its board of directors as an independent director. Mr. Upadhyay is a global business executive with more than 20 years of experience in the pharmaceutical and medical technology sectors, serving in financial and strategy roles covering multiple areas of the life sciences sector. He is currently the Executive Vice President and Chief Financial Officer of Zimmer Biomet, a leading global innovator and manufacturer of orthopedic solutions, a position he has held since July 2019. “We are delighted to have Suky join the Vertex Board. His extensive financial and strategic experience in health care, paired with his leadership and expertise across biopharma and medtech, make him a valuable addition to our board of directors,” said Reshma Kewalramani, M.D., Vertex’s Chief Executive Officer and President. “It’s an honor to join Vertex, a company focused on serial innovation with an

Armory Makes Continuous Deployment Achievable and Effortless, at any Scale, for all Developers18.5.2022 16:17:00 CEST | Press release

Armory, the Continuous Deployment company empowering development teams to easily, reliably, safely, and continuously deploy software at any scale, today announced public early access to their new Continuous Deployment-as-a-Service product. Armory Continuous Deployment-as-a-Service delivers declarative deployments, across multiple environments, that support advanced strategies, so developers can focus on building great code rather than deploying it. “We believe deploying software continuously, at any scale, should be achievable and effortless for all developers of the world, not just the likes of Google and Netflix,” said Jim Douglas, President and CEO, Armory. “It’s our vision and mission to unlock innovation through software to make software continuous, scalable, secure, and safe, so developers can improve and protect their customers’ experience with confidence and ease.” To effectively compete in a software-defined world, development teams must ensure a stellar customer experience. S

Sermo Survey Reveals New Lung & Breast Cancer Research Rated as Most Interesting by Oncologists Attending ASCO This Year18.5.2022 15:15:00 CEST | Press release

A new survey from Sermo, a physician-first online community and leader in global HCP insights, timed to the annual American Society of Clinical Oncology (ASCO) conference found that nearly half (47%) of attending oncologists are most interested in new data being presented about lung cancer. This is followed by a similarly high interest in new data about breast cancer, as reported by 44% of oncologists surveyed. Additionally, oncologists/hematologists reported they are most excited about learning about tumor targeting antibodies treatments as reported by 54% of those surveyed. Ahead of ASCO’s Annual Meeting, new cancer research and innovations are the driving reason surveyed oncologists/hematologists are attending the conference this year (59%). However, how they plan to attend looks different to many oncologists, as only 18% of oncologists/hematologists surveyed said they will attend ASCO in-person this year. A Look Into the Pandemic’s Negative Impacts on Cancer Care Globally Oncologis

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