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
Bentley Systems Announces Winners of the 2026 Year in Infrastructure Awards7.10.2026 20:55:00 EEST | Press release
(The Bentley Systems 2026 Year in Infrastructure Event) – Bentley Systems, Incorporated (Nasdaq: BSY), the infrastructure engineering software company, today announced the winners of the 2026 Year in Infrastructure Awards. For more than 20 years, the awards have honored the extraordinary work of infrastructure professionals and their innovative use of Bentley software to improve how infrastructure is designed, built, and operated. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261007964087/en/ Bentley Systems announced the winners of the 2026 Year in Infrastructure Awards on October 7, 2026 (Photo courtesy of Bentley Systems) In 2026, over 300 projects were nominated by organizations in 53 countries. Winners were selected across 12 categories spanning the infrastructure lifecycle, industries, and disciplines by a panel of independent judges during the Bentley Systems 2026 Year in Infrastructure Event, held October 6-7 in Sin
Day One Strategy Founders Recognised in The LDC Top 50 Most Ambitious Business Leaders for 20267.10.2026 20:00:00 EEST | Press release
Hannah Mann and Abigail Stuart, Co-Founders of Day One Strategy have been recognised as one of The LDC Top 50 Most Ambitious Business Leaders for 2026. The programme was created by private equity investor LDC, part of Lloyds Banking Group, in partnership with The Times. Since 2018, it has celebrated the ambition and achievements of hundreds of exceptional entrepreneurs. This year The LDC Top 50 attracted more than 620 nominations from across the UK, highlighting the depth of ambition among leaders building successful businesses in every region and sector. The leaders featured are driven by an appetite for growth that is helping to build stronger, more sustainable businesses and a more competitive UK economy. They are expanding internationally, developing new products and services, challenging established markets and investing in their people. Together, their businesses generate £1.4bn in annual revenues and employ almost 8,500 people. Headquartered in 55 towns and cities, they demonstr
TestMu AI Adds Evidence Packs to Kane CLI, Turning Every AI Test Run into One Portable, Shareable File7.10.2026 17:29:00 EEST | Press release
TestMu AI (formerly LambdaTest), the Full Stack Agentic AI Quality Engineering platform, announced evidence packs for Kane CLI, its terminal-first tool for natural language browser and mobile app testing. Every Kane CLI run now produces one sealed .evidence file that holds the complete record of what the AI agent was asked to do, what it did at each step, and what happened. Kane CLI launched in April 2026, giving developers and AI coding agents a way to run tests on real browsers and mobile apps from the terminal, in plain English, with a clear pass-or-fail verdict. Since launch, it has added AI-powered test case generation and the Assurance Lifecycle, which ties tests back to requirement documents. Evidence packs are the next step: a full record of every run. As AI agents write and run more tests, engineering teams need a clear answer to a simple question: what exactly did the agent do, and why did the run pass or fail? That proof is often spread across screenshots, log folders, and d
Medisca and EUROAPI Form Strategic Partnership to Strengthen API Access for Pharmaceutical Compounding7.10.2026 17:07:00 EEST | Press release
Medisca and EUROAPI have formed a strategic partnership focused on expanding API access for pharmaceutical compounding, creating differentiated access in North America and establishing a broader framework for international growth and peptide collaboration. For more than three decades, Medisca has built its business around the evolving needs of pharmaceutical compounders. That starts with the products it chooses to bring to market but extends much further to the manufacturers behind them, the documentation and technical information supporting them, and the quality systems that carry those products through to the customer. The partnership with EUROAPI advances that approach. Under the new strategic partnership, Medisca becomes EUROAPI’s first strategic distribution partner focused on bringing its European-manufactured APIs to the North American compounding market. The collaboration includes exclusive supply arrangements for selected APIs and creates a framework to expand the offering ove
iQmetrix Launches Vendor Managed Inventory Integration with Valor Communication7.10.2026 17:00:00 EEST | Press release
iQmetrix, the global provider of Intelligent Commerce Operating Systems for telecom, is launching a Vendor Managed Inventory integration with Valor Communication, a factory-direct wireless accessory manufacturer and distributor serving carriers, retailers, and dealers since 1997. Built into the iQmetrix Intelligent Commerce Operating System, the integration connects Valor's assortment directly to the platform telecom retailers already run their business on – so replenishment runs on real sell-through data instead of guesswork, and approved accessories move from Valor's floor to the peg without manual reordering. The integration will be available to retailers across the iQmetrix client base. The addition of Valor Communication marks another step in the rapid expansion of the iQmetrix Partner Ecosystem, bringing clients a growing network of integrated partners that work natively inside the platform they already run their business on. This press release features multimedia. View the full
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