Thermo Fisher Scientific Announces the Launch of the EXENT® Solution with IVDR Certification
24.8.2023 15:15:00 EEST | Business Wire | Press release
Thermo Fisher Scientific, the world leader in serving science, today announced the commercial launch of the EXENT® Solution, after receiving IVDR certification*. The EXENT solution is a fully integrated and automated mass spectrometry system designed to transform diagnosis and assessment for patients with monoclonal gammopathies, including multiple myeloma which, according to the World Health Organization in 2020, is the second most prevalent blood cancer worldwide[1]. The EXENT Solution is now commercially available in the following countries: Belgium, France, Germany, Italy, the Netherlands, Spain and United Kingdom.
The EXENT Solution enables clinical laboratories to measure, quantify and track specific endogenous M-proteins and exogenous therapeutic monoclonal antibodies with enhanced analytical sensitivity and specificity in serum. The EXENT Solution is easy to implement in routine laboratory use and features three integrated modules: EXENT-iP®500, an automated sample preparation instrument; EXENT-iX®500, a Matrix Assisted Laser Desorption Ionization - Time of Flight Mass Spectrometer (MALDI-ToF MS); and EXENT-iQ®, an intelligent and intuitive workflow software, including data review. The analyser is combined with the EXENT® Immunoglobulin Isotypes (GAM) immunoassay, a highly sensitive and specific immunoassay for measuring and quantifying IgG, IgA, and IgM.
“The EXENT Solution represents a significant breakthrough in innovation for the detection and monitoring of monoclonal immunoglobulins,” said Dr. Stephen Harding, Chief Scientific Officer, Protein Diagnostics, Thermo Fisher.
Traditionally, treatment for monoclonal gammopathies is determined by monitoring M-protein levels, which can indicate tumor size. With remarkable treatment successes in recent years, many patients are achieving M-protein concentrations below detectable limits using standard techniques. However, differences in disease progression persist within this group. The EXENT Solution addresses this unmet clinical need for more sensitive analytical methods that can differentiate between subsets, without initiating invasive bone marrow biopsy techniques too early.
The EXENT Solution was developed with Mayo Clinic intellectual property, combining industry leadership in innovation with Mayo’s expertise in monoclonal gammopathy research. The EXENT Solution is intended to aid diagnosis of monoclonal gammopathies and monitoring of multiple myeloma and Waldenström’s macroglobulinemia patients.
Key features and innovations of the EXENT Solution include:
- Enhanced Analytical Sensitivity: By pushing the boundaries of sensitivity, empowers clinicians and laboratories to monitor patients to a deeper level of response with just a serum sample.
- Dynamic Monitoring of Unique M-proteins: Tracking specific M-proteins over time, enabling the identification of additional M-proteins produced by emerging clones.
- Advanced Visualization: Presents M-proteins in a visually intuitive manner, supporting clinicians and laboratories to make informed decisions regarding endogenous M-proteins.
- Simplified and Less Invasive Serum Testing: Prioritizes patient comfort and convenience by requiring a simple and minimally invasive serum test.
- Smart Software with Automated Algorithm Data Processing: Supported by intelligent software equipped with automated algorithm data processing that minimizes manual labor, enhances data accuracy, and expedites analysis.
- Quantification with the Optilite® Analyser: In combination with the Optilite Analyser, provides precise quantification of M-proteins for comprehensive and accurate results.
Earlier this year, Thermo Fisher Scientific completed the acquisition of The Binding Site, adding protein diagnostics solutions, including diagnosis and monitoring for monoclonal gammopathies, to its specialty diagnostics portfolio.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
|
The EXENT Solution is not commercially available in the USA or China, future commercial availability cannot be guaranteed. Product availability is subject to country specific regulatory requirements. Contact your local representative for availability in your country. |
|
|
|
EXENT, EXENT Immunoglobulin Isotypes (GAM) immunoassay, EXENT-iP, EXENT-iQ, EXENT-iX, and Optilite are registered trademarks of The Binding Site Group Limited (Birmingham, UK) in certain countries. Other brand or product names may be trademarks of their respective holders. |
|
|
|
* The EXENT Solution consists of the following CE marked products: EXENT Analyser, IE800 (IVDR Class A, nonsterile), Immunoglobulin isotypes (GAM) for the EXENT Analyser - MSR801.M (IVDR Class C), EXENT Immunoglobulin Isotypes (GAM) Control Pack - MSQ801.M (IVDR Class C). |
[1] International Agency for Research on Cancer, World Health Organization 2020, (Viewed on 27/07/2023)
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230824591835/en/
Contact information
Media Contact Information:
Claire Deans
Marketing Manager, Global Communications
+44 121 456 9596
Claire.deans@bindingsite.com
Secondary Contact Information:
Amir Modirzadeh
Senior Director, Communications
(415) 867-9386
Amir.modirzadeh@thermofisher.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Philips and Imricor Launch Cardiac Interventional MR Lab Solution, Expanding Longstanding Collaboration27.8.2026 22:27:00 EEST | Press release
Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and Imricor Medical Systems (ASX: IMR), a pioneer and world-leading developer of MR-compatible products for interventional MR procedures, today announced a new Interventional MR (iMR) lab solution for Philips 1.5T MR. The first commercially available configuration* combines Philips’ 1.5T MRI platform and Imricor's portfolio of iMR systems and consumables, enabling an MR-guided workflow for cardiac intervention, without compromising on MR field strength. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260827693715/en/ Meeting the need for greater tissue insight during cardiac intervention Cardiac arrhythmias affect millions of people worldwide, and catheter ablation is an established and increasingly utilized treatment for many complex cardiac arrhythmias. Yet today, these procedures continue to rely primarily on X-ray fluoroscopy, which provides only
Xsolla Launches Game Biz Institute, an Editorial Platform Where Industry Practitioners Explain the Business of Games27.8.2026 18:32:00 EEST | Press release
Xsolla, a global commerce company, today announced the launch of Game Biz Institute (GBI), an editorial platform where named industry practitioners and researchers examine the commercial layer of games: direct-to-player distribution, payments, monetization, user acquisition, and retention. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260827362663/en/ Graphic: Xsolla Game design has a curriculum. The business of games does not. Engines, pipelines, production, and narrative are taught at hundreds of universities, while the commercial machinery that determines whether good work becomes a durable company is still learned through expensive trial and error, usually after the decisions that mattered have already been made. GBI was built to close that gap by publishing what practitioners have actually learned running these businesses. "Game developers have never had more data and less clarity," said Chris Hewish, President of Xsol
Star Wars Zero Company™ Now Available On PC, PlayStation 5 and XBOX Series Consoles27.8.2026 18:00:00 EEST | Press release
Electronic Arts Inc. and Bit Reactor, in collaboration with Lucasfilm Games, announced today that Star Wars Zero Company™, a single-player turn-based tactics game set in the twilight of the Clone Wars™, is now available for PC via the EA app, Steam, and Epic Games Store, and PlayStation®5 and XBOX Series consoles. In Star Wars Zero Company, former Republic officer Hawks and Zero Company, an elite squad of unconventional professionals for hire, are recruited for an operation by Republic Intelligence. From ex-nobles to ex-cons, they now share one mission: Stop the Infinite Coil, a Separatist-aligned cult, and their leader Kundri Fathom before the deadly Shadow Plague consumes the galaxy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260827012810/en/ https://www.youtube.com/watch?si=7SYogg8ILAD3tUG3&v=AxAgeglgSeA&feature=youtu.be “After all these years of hard work from our amazing team, Star Wars Zero Company is a go for laun
Rehlko Joins Wisconsin Data Center Coalition as Newest Energy Resilience Member, Reinforcing Its Role at the Center of AI and Digital Infrastructure Growth27.8.2026 16:15:00 EEST | Press release
Rehlko, a global industrial energy resilience platform providing custom-engineered, integrated power solutions for mission-critical infrastructure worldwide, today announced it has joined the Wisconsin Data Center Coalition (WIDCC) as the organization's newest energy resilience member. The membership reflects Rehlko's commitment to advancing Wisconsin's role as a leader in responsible AI infrastructure development, built on reliable and scalable power. Rapid growth in hyperscale and enterprise data center investment is reshaping markets across the world, and Rehlko is building the power infrastructure that makes it possible. Sitting at the intersection of the structural forces driving AI infrastructure expansion, grid reliability, and accelerating electrification, Rehlko brings more than a century of engineering depth and lifecycle capability to the table. WIDCC brings together stakeholders from across Wisconsin's technology, utility, economic development, workforce development, govern
GenNx360 Capital Partners Closes Fourth Flagship Fund at $865 Million27.8.2026 15:30:00 EEST | Press release
GenNx360 Capital Partners (“GenNx360” or “the Firm”), a New York City-based private equity firm investing in U.S. lower middle market industrial services and business services companies, today announced the successful closing of GenNx360 Capital Partners IV, L.P. (“Fund IV” or “the Fund”), with $865 million in commitments, exceeding its target. Fund IV is the largest fund raised in GenNx360’s history. Fund IV was supported by a diverse group of existing and new investors including leading pensions, asset managers, insurance companies, foundations, and family offices, reflecting conviction in the firm’s disciplined investment approach, operational value creation model, and tenured, diverse team. Fund IV will continue GenNx360’s differentiated strategy of partnering with lower middle market founders and management teams to scale essential services businesses. Fund IV has made five investments to date across infrastructure services, testing and inspection services, aerospace and defense,
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