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
Kioxia Appoints Yoshihiko Kawamura as Chief Financial Officer27.2.2026 10:15:00 EET | Press release
Kioxia Holdings Corporation (TOKYO:285A), a world leader in memory solutions, today announced the appointment of Yoshihiko Kawamura as Chief Financial Officer (CFO), effective April 1, 2026. Mr. Kawamura brings extensive international experience to Kioxia, having held assignments at Mitsubishi Corporation’s U.S. headquarters, served as General Manager of its Chicago office, and completed a tenure at the World Bank. At Hitachi, Ltd., he held senior leadership positions, including Chief Strategy Officer (CSO), Chief Financial Officer (CFO), and Chief Risk Management Officer (CRMO), where he was instrumental in leading the company’s management reforms. Since joining Kioxia as Executive Vice President in June 2025, Mr. Kawamura has worked closely with the executive team to advance the business through strategic capital and financial planning. Following its initial public offering on the Prime Market of the Tokyo Stock Exchange in December 2024, Kioxia is entering a new phase of growth char
DNP Invests in Rapidus to Support the Establishment of Mass Production for Next-Generation Semiconductors27.2.2026 09:18:00 EET | Press release
Dai Nippon Printing Co., Ltd. (DNP, TOKYO:7912) today announced that it has participated in Rapidus Corporation’s funding round as one of the round investors. This strategic funding initiative supports Rapidus’ plan to steadily progress from its current R&D phase to mass production of 2nm (10⁻⁹ meters) logic semiconductors by 2027. Through this initiative, DNP will advance the development and mass production of EUV lithography photomasks and support Rapidus as it establishes a mass production system for 2nm & next-generation semiconductors. Background In recent years, the rise in energy consumption, in line with increased data generation, has become a challenge, driving demand for next-generation semiconductors capable of improving device performance and reducing power consumption. Next-generation semiconductors manufactured using EUV lithography enable the formation of finer patterns on silicon wafers compared to currently available technologies. This in turn is boosting expectations
EdgeConneX Looks to Enter Swedish Market as Part of European Data Center Expansion Strategy27.2.2026 09:05:00 EET | Press release
EdgeConneX®, an EQT portfolio company with an extensive Pan-European data center footprint, looks to expand its presence with a new site located in Skellefteå, Sweden. The data center site will be acquired from Lyten, a global company that specializes in lithium-sulfur batteries and energy storage. The site would support EdgeConneX broader strategy to expand digital infrastructure capacity across the Nordics. Subject to the completion of applicable administrative and regulatory processes, EdgeConneX will look to develop a data center campus with potential capacity of up to one gigawatt in support of future AI and cloud computing workloads. Upon completion, the data center campus would be one of the largest facilities in Europe that would be primarily powered by renewable energy. “Sweden represents an attractive long‑term market for digital infrastructure investment. The country’s access to renewable energy, stable power grid, technical workforce and strong sustainability framework alig
Lyten Completes Acquisition of Northvolt Sweden and Establishes its First Lyten Industrial Hub in Sweden27.2.2026 09:00:00 EET | Press release
Lyten, a global leader in lithium-sulfur batteries and energy storage, announced today that it has completed the acquisition of Northvolt Ett and Ett Expansion (Skellefteå, Sweden) and Northvolt Labs (Västerås, Sweden). The Northvolt Sweden acquisition includes 16 GWh of existing battery manufacturing capacity, more than 160 hectares of land, infrastructure and buildings to support expanded manufacturing and industrial activities, and the largest and most advanced battery research and development center in Europe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260226538293/en/ Northvolt Labs, the largest battery research and development facility in Europe. Located in Västerås, Sweden. Lyten additionally announced the formation of the Lyten Industrial Hub, located in Skellefteå, at the Northvolt Ett site. The industrial hub will utilize the infrastructure built by Northvolt and access to abundant, clean hydro power to co-loca
SOLUM and Competera Expand Partnership to Integrate AI-Driven Pricing Solutions with Real-Time ESL Execution Across Europe27.2.2026 09:00:00 EET | Press release
SOLUM (KOSPI: 248070) and Competera announced the expansion of their strategic partnership to further connect AI-driven pricing intelligence with real-time Electronic Shelf Label (ESL) execution across European retail networks. The announcement follows strong engagement at EuroShop, where the integrated solution attracted significant interest from the local retail operators. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260226065052/en/ SOLUM and Competera announced the expansion of their strategic partnership (Image: SOLUM) The collaboration brings together Competera’s AI-driven pricing solutions for enterprise retail with SOLUM’s Newton ESL platform, enabling retailers to align advanced price optimization with synchronized shelf-edge communication. Competera’s platform applies machine learning and advanced analytics to help retailers balance competitiveness and value-based pricing, strengthen customer loyalty, improve pri
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