Thermo Fisher Scientific Announces the Launch of the EXENT® Solution with IVDR Certification
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
Rimini Street to Report Fourth Quarter and Fiscal Year 2025 Financial Results on February 19, 202626.1.2026 20:46:00 EET | Press release
Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™, and the leading third-party support provider for Oracle, SAP and VMware software, today announced it will report earnings after market close on February 19, 2026. The company will host a conference call and webcast on that date to discuss the fourth quarter and fiscal year 2025 results and the 2026 outlook at 5:00 p.m. Eastern / 2:00 p.m. Pacific time. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260126188817/en/ Rimini Street to Report Fourth Quarter and Fiscal Year 2025 Financial Results on February 19, 2026 A live webcast of the event will be available on Rimini Street’s Investor Relations site via the Rimini Street IR events link and directly via the webcast link. Dial-in participants can access the conference by dialing 1-800-836-8184. A replay of the webcast will be available for one year following the event. About Rimini Street, In
SES Acknowledges Fitch’s Rating Action and Reiterates Deleveraging Plan26.1.2026 20:07:00 EET | Press release
SES S.A. (“SES” or the “Company”), a leading space solutions company, acknowledges the credit rating action announced by Fitch today, which follows the release of SES’ Q3 2025 results and Intelsat integration update. SES continues to be rated investment grade by Fitch with a stable outlook. SES management reiterates that the Company continues to execute on its strategy with a clear plan to strengthen its key credit metrics over time. The Company also has a clear view of the multiple cash generating levers available to it that it believes can substantially support and accelerate the deleveraging plan. SES management will use these levers in a disciplined way and keep investors informed as they deliver on the strategic plan. Consistent with this plan, it remains management’s intention to delever, with a policy objective of reducing adjusted net leverage(1) to at least 3.0x or below. (1) Adjusted net leverage is defined as Adjusted Net Debt divided by Adjusted EBITDA. Adjusted Net Debt is
A2RL Drone Championship Sets the Pace for AI in Autonomous Flight26.1.2026 19:17:00 EET | Press release
The Abu Dhabi Autonomous Racing League (A2RL) Drone Championship delivered a decisive test of autonomous and human performance, as Technology Innovation Institute’s TII Racing set the fastest autonomous lap to win the AI Speed Challenge, while a human first-person-view (FPV) pilot, MinChan Kim – World FPV Champion, narrowly claimed victory in the Human vs AI finale. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260126735530/en/ A2RL Drone Championship Sets the Pace for AI in Autonomous Flight (Photo: AETOSWire) Organised by ASPIRE, the innovation acceleration arm of the Advanced Technology Research Council (ATRC), the event highlighted both the rapid progress of vision-based autonomy and the narrow margins that still separate human instinct from machine execution at speed. Held over two days on 21–22 January during UMEX, the A2RL Championship brought together leading AI research teams and world-class FPV pilots to compete a
Zayed Sustainability Prize Opens Global Call for Submissions for 2027 Cycle26.1.2026 17:25:00 EET | Press release
The Zayed Sustainability Prize, an affiliate of Erth Zayed Philanthropies and the UAE’s pioneering global award for sustainability and humanitarian innovation, has opened submissions for its 2027 cycle. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260126912976/en/ Winners of the 2026 Zayed Sustainability Prize (Photo: AETOSWire) The Prize carries forward the vision and legacy of the UAE’s founding father, Sheikh Zayed bin Sultan Al Nahyan, by supporting those advancing a more inclusive and sustainable world. Now in its 18th year and with a total of US $7.2 million in funds, the Prize invites small and medium enterprises, nonprofit organisations, and high schools to submit innovative solutions across six categories: Health, Food, Energy, Water, Climate Action, and Global High Schools. Commenting on the launch of the 2027 submissions cycle, H.E. Dr. Sultan Ahmed Al Jaber, UAE Minister of Industry and Advanced Technology and
2026 Japan Prize: Two U.S. Scientists and One Japanese Scientist Awarded26.1.2026 16:00:00 EET | Press release
The Japan Prize Foundation announced the winners of the 2026 Japan Prize at 1:00 p.m. on 21 January 2026. Prof. Cynthia Dwork (USA) has been awarded the Japan Prize in the field of Electronics, Information, and Communication. Prof. Shizuo Akira (Japan) and Prof. Zhijian "James" Chen (USA) have been awarded the Japan Prize in the field of Life Sciences. For this year’s Japan Prize, Prof. Dwork is being recognized for her Contribution to leading research for building an ethical digital society, including differential privacy and fairness. Prof. Akira and Prof. Chen are being recognized for their Discovery of the nucleic acid sensing mechanism by the innate immune system. For the 2026 Japan Prize, the Foundation asked approximately 16,000 prominent scientists and engineers from around the world to nominate researchers working in this year’s fields. We received 107 nominations for the field of Electronics, Information, and Communication, and 185 nominations for the field of Life Sciences.
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