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
Venture Global Secures New Agreements to Support Expansion of Existing Grid-Independent Power Network15.10.2026 13:00:00 EEST | Press release
Venture Global, Inc. (NYSE: VG) today announced it has entered into power and grid frame agreements with GE Vernova and Baker Hughes Energy Services for up to 16 new, 720 MW power island units and associated power transformer equipment, supporting the continued expansion of its existing behind-the-meter, Island-Mode industrial power network that is not reliant on the grid. The agreements will enable continued growth in Venture Global’s LNG business and provide a pathway to make up to 10 GW of new compute capacity available over time – at sites owned or controlled by the Company - for potential adjacent infrastructure and data centers. With Island Mode power generated using this incremental dedicated on-site infrastructure, the expansion would place no additional demand on the public electric grid or public water utilities and, therefore, have no added costs to local consumers. This new capacity would build on the company’s 4.5 gigawatts of Island Mode modular, gas-fired generation that
Moncler Re/Icons: Cher, JENNIE and Grace Jones Re/Define What It Means to Be a Pioneer15.10.2026 13:00:00 EEST | Press release
Since its origins, Moncler has been at the forefront of the ascent, equipping the world’s most intrepid pioneers – those first to explore, so others can follow. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261015573482/en/ MONCLER RE/ICONS CHER That spirit lives on in the new Moncler Re/Icons collection, which takes iconic styles from the brand’s archives and reimagines them for a new generation, brought to life by three cultural pioneers who have forged their own extraordinary paths: Cher, JENNIE and Grace Jones. Each has spent a career making moves, moving mountains and reaching for higher peaks, refusing to follow the path already laid out before them. Pioneers in their own singular ways, they have blazed trails for others to follow and built enduring legacies that continue to shape what comes next. Inspired by archival photographs of alpine pioneer and early Moncler collaborator Lionel Terray, the campaign brings our p
AI Investment Is Surging, but Businesses Are Struggling to Prove the Value, HTEC Global Study Finds15.10.2026 11:42:00 EEST | Press release
HTEC, a global product engineering and AI transformation company, today launches The HTEC AI Value Realization Report 2026, revealing a new challenge emerging as organizations move beyond AI experimentation: investment is accelerating faster than many companies’ ability to measure, govern and consistently realize its value. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261015407055/en/ HTEC, a global product engineering and AI transformation company, today launches The HTEC AI Value Realization Report 2026, revealing a new challenge emerging as organizations move beyond AI experimentation: investment is accelerating faster than many companies’ ability to measure, govern and consistently realize its value. The independent study finds that 79% of organizations have increased AI investment over the past year, with spending rising by 31% on average. Yet 77% of executives now believe AI value is constrained more by people and pr
Flowdesk Europe Receives Payment Institution Authorization from the ACPR Under PSD215.10.2026 10:30:00 EEST | Press release
Flowdesk, a global liquidity provider and digital asset trading and infrastructure provider, today announced that its European entity, Flowdesk Europe, has been authorized as a Payment Institution by the French Prudential Supervision and Resolution Authority, l'Autorité de contrôle prudentiel et de résolution (ACPR), under the second Payment Services Directive (PSD2). The authorization allows Flowdesk Europe to provide custody and transfer services for e-money tokens (EMTs), the fiat-referenced stablecoins regulated under the Markets in Crypto-Assets (MiCA) regulation, to its clients across the European Union. The authorization follows the entity’s Crypto-Asset Service Provider (CASP) authorization received from the Autorité des Marchés Financiers (AMF) under MiCA at the end of June this year. With both authorizations in place, Flowdesk Europe can now support its EU clients across the trading, custody, and transfer of crypto-assets and EMTs, reflecting the firm’s long-standing commitme
Too Good To Go Expands Its Marketplace Beyond Food15.10.2026 10:30:00 EEST | Press release
Too Good To Go, the world's largest marketplace for surplus food, today announced that it is expanding its Marketplace beyond food, enabling retailers to redistribute surplus across personal care — including skincare, haircare, oral care and beauty products — pet care, flowers and plants, nutrition and supplements, and home, initially spanning cleaning and laundry products and décor. More than 8,500 stores already supply products across these areas, around one third of which were already working with Too Good To Go to redistribute surplus food. “In today’s society, we have built incredibly efficient processes for producing and selling things at scale, creating abundance, but we have not built the same efficiency into making sure what is left over gets used. As our lives have become more convenient, we have become less conscious of what those things are worth. We used to finish what was on the plate, find a use for what we had and instinctively pause before throwing something away. Too
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