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
World Employment Confederation’s 59th Annual Conference to Address Critical Global Labour Market Concerns8.5.2026 08:12:00 EEST | Press release
Taking place on 12-13 May in Toronto and entitled ‘Grow With Talent’, this year’s World Employment Conference – co-organised with ACSESS – arrives at a time of profound economic uncertainty. This gathering of leaders and experts will help define the path forward for the global labour market and set the stage for discussions at the 114th Session of the International Labour Conference (ILC) in June. Bettina Schaller, President of World Employment Confederation (WEC) says: “The question at the heart of this year’s World Employment Conference is: how will we mobilise the world’s talent to drive growth in an era of disruption?At a time of accelerating AI adoption, rapid demographic change and an uncertain global economic outlook, pressure on labour markets is intensifying. The issue is no longer simply shortages, but how effectively talent is developed, deployed and matched to where it is needed most.” As advocates for the private employment services industry, WEC brings together policymake
Esentia Announces Successful Pricing of 6.125% Senior Notes Due 2033 and 6.500% Senior Notes Due 20388.5.2026 04:24:00 EEST | Press release
Esentia Energy Development, S.A.B. de C.V. (“ESENTIA” or the “Company”), today announced the pricing of U.S.$1,000,000,000.00 aggregate principal amount of its 6.125% Senior Notes due 2033 (the “2033 Notes”) and U.S$1,000,000,000.00 aggregate principal amount of its 6.500% Senior Notes due 2038 (the “2038 Notes” and, together with the 2033 Notes, the “Notes”) to be issued by the Company in a private offering to qualified institutional buyers in accordance with Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”), and outside the United States to non-U.S. persons in accordance with Regulation S under the Securities Act. The 2033 Notes will be issued at a price of 99.517%, and the 2038 Notes will be issued at a price of 98.444%. The 2033 Notes mature on July 30, 2033, and the 2038 Notes mature on July 30, 2038, and will be fully and unconditionally guaranteed by certain of the Company's subsidiaries. The settlement of the Notes is expected to take place on May 14
83% of Restaurants Are Invisible in AI Search: New Uberall Report Reveals the Discovery Gap Reshaping the Quick Service Restaurant Industry7.5.2026 20:35:00 EEST | Press release
Uberall, the global leader in location marketing technology, today released Fast Food, Faster Discovery: The 2026 GEO Playbook for Multi-Location QSRs — the industry’s first benchmark report measuring how AI assistants recommend restaurants and how multi-location QSR (Quick-Service Restaurant) brands can adapt their local marketing strategies for AI-mediated search. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507962493/en/ Fast Food, Faster Discovery: Why AI Is the New Drive-Thru The report draws on Uberall’s proprietary GEO Studio benchmark data and aggregated performance metrics from its global QSR customer base. Its central finding: as consumer restaurant discovery rapidly shifts from traditional search to AI assistants, the majority of QSR locations are effectively absent from AI-generated recommendations — at the exact moment AI is becoming consumers’ primary discovery channel. This visibility gap arrives as the Q
Department of Health - Abu Dhabi and ŌURA Partner to Advance Preventive Health in Abu Dhabi7.5.2026 19:57:00 EEST | Press release
Department of Health—Abu Dhabi (DoH) and ŌURA, maker of the world’s leading smart ring, Oura Ring, today announced a joint research programme to study how continuous wearable data can advance preventive health. The collaboration marks the beginning of a long-term partnership to advance Abu Dhabi’s prevention-first, data-driven healthcare agenda, and will initially focus on women’s health and cardiometabolic risk. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507073495/en/ HE Mansoor Al Mansoori (Left) and Tom Hale (Right) The collaboration builds on Abu Dhabi’s advanced public health infrastructure and longitudinal health data assets, integrating them with ŌURA’s real-time, continuous insights across key health indicators. Together, this creates a strong foundation for understanding health at a population level, enabling the identification of risk factors and supporting a shift from reactive care to more proactive, perso
Rave Sues Apple in Five Countries Over App Store Removal7.5.2026 18:03:00 EEST | Press release
Rave Inc. (“Rave” or the “Company”), the developer and operator of the Rave app, a cross-platform co-viewing “super app” with more than 225 million downloads, today announced that it has filed antitrust lawsuits against Apple in five countries: the United States, Canada, Brazil, the Netherlands and Russia. The lawsuits challenge Apple’s unilateral and anticompetitive decision to remove Rave from its App Store, thereby distorting competition, reducing consumer choice in co-viewing functionalities and increasing the costs to users of switching between iPhone and competing smartphone devices. Rave operates a social entertainment app that allows users in different locations to watch their favorite videos, movies, and TV shows together in real time across multiple operating systems and devices, including iOS, Android, Windows and macOS, and communicate through chat and voice. Rave alleges that this cross-platform experience threatened Apple’s closed iOS ecosystem, which Apple maintains by l
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