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
Egon Zehnder Elects German Herrera as New Chair28.1.2026 21:01:00 EET | Press release
Egon Zehnder, the world’s premier leadership advisory firm, today announced that, in accordance with its established governance and three-year election cycle, German Herrera has been elected as the Firm’s next Chair by its worldwide partnership. Herrera will assume the role effective March 1, 2026. He will succeed Michael Ensser, who has held the position since 2022, in a planned succession at the conclusion of his regular term. Herrera joined the Firm in 1998 in Bogotá and has helped shape the Firm’s global presence, taking on a broad range of leadership roles, from co-leading the Global Family Business Advisory Practice to serving on the Executive Committee and the Market Council. Most recently, Herrera has guided Egon Zehnder’s U.S. market through a period of impressive growth and transformation, which today includes 15 offices and more than 150 consultants. As the first Latinx person in this role in the industry, he actively forges strategic partnerships and joint ventures. With ex
De' Longhi Group - Record Preliminary 2025 Revenues of €3.8 Billion, up 10.4% at Constant Exchange Rates28.1.2026 20:25:00 EET | Press release
Below are the preliminary 2025 revenues for the De’ Longhi S.p.A. Group: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260128191504/en/ 12 months, revenues at € 3,801.5 million, growing at 8.7% (+10.4% at constant currency); fourth quarter, revenues at € 1,340.0 million, growing at 5.7% (+8.2% at constant currency). Fabio de' Longhi, CEO of the Group, stated: "The Group achieved solid growth at constant currency of 10.4% in 2025, characterized by consistent results throughout the year. We are particularly pleased with the excellent performance achieved in the fourth quarter, which successfully overcame the challenges posed by the current market environment. The household division consolidated its recent growth momentum during the quarter, with organic growth of 5.2% against a challenging year-over-year comparison. This performance was primarily driven by the structural trend in coffee, amplified by strategic media investmen
Organon Completes Divestiture of JADA ® System to Laborie28.1.2026 19:45:00 EET | Press release
Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today the successful closing of the sale of its JADA® System to Laborie Medical Technologies Corp. Please see our prior announcement for a summary of the transaction terms. Indications for Use The JADA® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. Contraindications Ongoing intrauterine pregnancy Untreated uterine rupture Unresolved uterine inversion Current cervical cancer Known uterine anomaly Current purulent infection of vagina, cervix, or uterus For C-sections: Cervix <3 cm dilated before use of JADA Warnings Avoid excessive force when inserting JADA into the uterus or trauma to uterine wall may occur, including perforation. The safety and effectiveness of the JADA System in delivery at a gestational age <34 weeks or, if multiples, uter
Laserfiche Expands AI Data Capture with Auto-Classification to Transform Data into Business Intelligence28.1.2026 17:00:00 EET | Press release
Laserfiche — the leading SaaS provider of intelligent content management — today announced major enhancements to its AI-powered data extraction tool, Smart Fields. The update introduces automated document classification and tagging, allowing organizations to move from unstructured content to informed decisions in seconds. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260128228490/en/ Using natural language prompts instead of rigid, ruled-based OCR, Smart Fields can now identify document type — such as invoices, taxpayer identification forms, or student transcripts — and automatically apply the correct metadata template using AI. Users can also use Smart Fields to automatically add informational and security tags to files that meet certain criteria, defined using a natural language prompt. Users can capture key details, route documents, and apply the proper metadata tags instantly and at scale. “Success in today’s AI-driven
Andersen Consulting Adds Collaborating Firm HaystackID28.1.2026 16:30:00 EET | Press release
Andersen Consulting strengthens its cybersecurity and technology capabilities through a Collaboration Agreement with HaystackID, a U.S.-based provider of eDiscovery, legal data, and cyber discovery services. Founded in 2011, HaystackID works closely with law firms, corporations, and governmental agencies to manage complex, data-intensive legal matters, including civil litigation, regulatory inquiries, and internal investigations. The firm delivers end-to-end litigation support through cyber discovery, digital forensics, managed review, compliance, and information governance services, enabling clients to identify, analyze, and defensibly produce critical data. Leveraging proprietary AI-driven platforms and expert-led review teams, HaystackID supports clients across North America and Europe, including Fortune 100 companies. “As legal and regulatory environments become more data-driven and time-sensitive, we continue to evolve our litigation support capabilities, from advanced analytics a
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