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
HJS Foundation Releases JEP Protocol & HJS Framework: The "Black Box" for AI, Enabling Verifiable Human Oversight24.3.2026 05:36:00 EET | Press release
HJS Foundation (Human Judgment Systems Foundation) today released two complementary solutions: the Judgment Event Protocol (JEP) and the Human Judgment Structure (HJS) framework. As a minimalist open standard, JEP generates tamper-proof records of AI decision accountability, just like an aircraft black box; HJS embeds human judgment logic into AI operation processes — together, they transform "human oversight" from a regulatory requirement into a verifiable technical fact, providing an optional technical solution for AI accountability. How to prove that AI decisions (such as loan approvals, medical diagnoses, border screenings, etc.) have undergone human review? JEP generates immutable audit trails of human intervention through four cryptographic primitives — Judge, Verify, Delegate, Terminate; HJS builds a controllable and accountable system to prevent risks such as AI drift and ensure that human judgment guides AI operations. Current systems rely on alterable post-hoc documentation,
Access Advance Welcomes New VDP Pool Licensors and Releases Independent Economic Analysis Confirming FRAND Compliance24.3.2026 02:00:00 EET | Press release
Access Advance LLC today announced that Sharp Corporation, CB Cline, SK Planet, and Telechips, Inc have joined the Access Advance Video Distribution Patent Pool (VDP Pool) as Licensors, further expanding the pool's portfolio of patents for modern video codec technologies (HEVC, VVC, VP9, and AV1). The announcement coincides with the release of an independent economic analysis by Criterion Economics confirming that the VDP Pool's royalty structure is fair, reasonable, and nondiscriminatory (FRAND). Sharp, a global leader in consumer electronics and display technologies, brings decades of research and development in video processing and compression to the VDP Pool. The additions of CB Cline, SK Planet, and Telechips, Inc further expand the pool’s patent coverage. These additions reinforce the VDP Pool’s position as the leading licensing program for modern video codec technologies powering the streaming experiences of consumers worldwide. "Sharp, CB Cline, SK Planet, and Telechips each br
Power Integrations Extends Flyback Topology to Enable 440 W, Offering Simpler Alternatives to Resonant Power Designs23.3.2026 23:45:00 EET | Press release
APEC 2026 – Power Integrations (NASDAQ: POWI), the leader in high-voltage integrated circuits for energy-efficient power conversion, today introduced a breakthrough in flyback topology extending the power range of flyback converters to 440 W—well beyond the limits that traditionally required more complex resonant and LLC topologies. The new TOPSwitchGaN™ flyback IC family unites the company’s groundbreaking PowiGaN™ technology with its iconic TOPSwitch™ IC architecture, reducing complexity, eliminating heat sinks in many cases, shortening design time, improving manufacturability, and lowering total system cost. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260323686299/en/ The new TOPSwitchGaN™ flyback IC family extends the power range of flyback converters to 440 W—well beyond the limits that traditionally required more complex resonant and LLC topologies. “This is more than a product evolution—it’s a fundamental shift in
I-Pulse Announces Strategic Partnership to Advance Geothermal Pulsed Power Applications in the Millungera Basin, Australia23.3.2026 23:40:00 EET | Press release
I-Pulse Co-Founder, Chairman, and CEO Robert Friedland, I-Pulse Co-Founder and Head of Technology Laurent Frescaline, and Sunrise Energy Metals Managing Director Sam Riggall, are delighted to announce a partnership to deploy and validate I-Pulse’s G-Pulse pulsed power drilling technology in the Millungera Basin, a large-scale geothermal clean energy resource located in northwest Queensland, Australia. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260323421297/en/ Left: Millungera Basin location in Queensland, Australia. Right: Millungera Basin (in brown) to the east of the Mt Isa Inlier (in red) and EPG permit areas. Under an earn-in agreement, I-Pulse will assume operational control and funding of the Millungera Basin Geothermal Project through a capital-light, technology-driven joint venture structure. Sunrise remains a free-carried minority holder of the site, ensuring alignment, continuity and local resourcing, while I-
The Estée Lauder Companies’ Statement on Potential Transaction with Puig23.3.2026 22:15:00 EET | Press release
The Estée Lauder Companies Inc. (NYSE: EL) confirms that it is in discussions regarding a potential business combination with Puig, in which the two companies would potentially merge their businesses. No final decision has been made, and no agreement has been reached. Unless and until an agreement is signed between the companies, there can be no assurances regarding the deal or its terms. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding a potential transaction and the anticipated timing, terms, and completion of any such transaction. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the possibility that no agreement will be reached, tha
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