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
Interactive Brokers Expands AI Integration Capabilities – Adding ChatGPT and Grok to Its Growing Suite of Agentic Trading Tools22.6.2026 17:00:00 EEST | Press release
Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced the expansion of its agentic trading capabilities with the addition of ChatGPT and Grok, further broadening a growing ecosystem of AI platform integrations that began with Claude. Available through certified AI connector marketplaces across multiple leading platforms, these integrations allow clients to research, analyze, and generate instructions with speed and efficiency to uncover new trading and investing opportunities instantly. With this release, Interactive Brokers also extends the selection of products available for order instructions to include support for options, futures and futures options in addition to equities and ETFs. “We continue to see growing interest from investors in using artificial intelligence as a more natural way to interact with financial markets,” said Milan Galik, Chief Executive Officer of Interactive Brokers. “Adding ChatGPT and Grok, together with support for options and fut
IQM Named Among Quantum Collaborators in HPE's New Hybrid Quantum-HPC Platform22.6.2026 16:22:00 EEST | Press release
Hewlett Packard Enterprise has named IQM Quantum Computers among the companies collaborating on its hybrid classical-quantum computing platform, announced at HPE Discover Las Vegas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260622035759/en/ IQM Radiance quantum computer at HPE Discover Las Vegas 2026 IQM, a global leader in full-stack superconducting quantum computers, is contributing superconducting quantum processor technology to the effort, in which HPE is integrating multiple quantum modalities with its Cray supercomputing infrastructure. This collaboration strengthens IQM's global expansion plans as the company prepares for its planned Nasdaq listing through a merger with Real Asset Acquisition Corp. (Nasdaq: RAAQ). For IQM, HPE's selection places the company at the center of one of the computing industry's most significant efforts to bring quantum and high-performance computing together, an integration widely rega
Return Abuse Goes Mainstream as Nearly Half of Consumers Use AI in Return Claims, New Riskified Research Finds22.6.2026 15:30:00 EEST | Press release
Riskified (NYSE: RSKD), a global leader in ecommerce fraud detection and risk intelligence, today released a new global report, “Rewriting the Rules on Returns”, exploring how consumer attitudes and behaviors around ecommerce returns are evolving in the age of artificial intelligence (AI). The Riskified-commissioned study, conducted by eTail Insights, is based on a survey of 2,091 consumers across seven countries, alongside in-depth interviews with senior leaders from many of the largest retail companies in the world. The research finds that return abuse behaviors are increasingly normalized, while nearly half of consumers already use generative AI tools to assist with return or refund claims. At the same time, merchants are responding by tightening return policies, shortening return windows, and deploying advanced AI detection to better distinguish between legitimate behavior and abuse patterns. Key Findings Nearly half of consumers (50%) report using generative AI tools such as ChatG
Forrester Unveils Agendas For 2026 Technology & Innovation Forums In North America And EMEA22.6.2026 15:00:00 EEST | Press release
Forrester (Nasdaq: FORR) today announced the full conference agendas for its Technology & Innovation Forum Central (Austin, September 14–15, 2026), Technology & Innovation Forum EMEA (London, September 30–October 1, 2026), and Technology & Innovation Forum East (New York City, November 4–5, 2026). This year’s theme, “The IT Singularity,” dives into the new AI era in which AI has become ubiquitous and no longer a competitive advantage on its own. To succeed, technology leaders including chief information officers, chief data officers, and chief AI officers need to integrate AI into their operating models, modernize software development and IT operations, strengthen data and governance practices, and align technology investments with business strategy. Across the Forums, tech leaders and their teams will learn how to scale AI responsibly, accelerate delivery, and strengthen executive confidence in an increasingly autonomous, AI-driven environment. Key sessions include: The AI Voyage — Fr
AdvanCell Establishes U.S. Global Headquarters and Secures Flagship Manufacturing Facility in Greater Boston to Drive Growth Strategy22.6.2026 15:00:00 EEST | Press release
AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, today announced the establishment of its U.S. Global Headquarters in the Greater Boston area, and the lease of a new 128,000-square-foot facility that will become the Company’s U.S. flagship manufacturing center supporting its long-term growth and commercialization strategy. The expansion marks an important milestone in the Company’s evolution into a U.S.-based radiopharmaceutical company with integrated operations spanning North America and Australia. The investment reflects AdvanCell's strategy to expand its U.S. presence and build the infrastructure needed to support the development and future commercialization of ADVC001 and its Lead-212 targeted alpha therapy pipeline. Located in Greater Boston, the Innovation Park campus owned by IQHQ provides access to a world-class life-science ecosystem, supporting the next phase of the Company’s growth. The Andover facility will
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