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
Amadeus Redefines Travel Advertising to Help Brands Capture Demand Earlier28.5.2026 14:00:00 EEST | Press release
Amadeus today introduced the Amadeus Travel Advertising Platform at its Advertising Summit in Nice, France. Leveraging Accenture’s agentic framework for campaign execution, the platform outlines a new approach designed to help travel companies make faster, smarter advertising decisions based on where demand is forming — not just where it has already converted. Travel advertising has become increasingly complex, fragmented across channels and often driven by historical performance signals that arrive too late to capture emerging demand. As travelers plan trips across AI chatbots, search, social, metasearch, content platforms and OTAs long before booking, travel brands face rising acquisition costs and growing pressure to prove return on investment. The Amadeus Travel Advertising Platform connects forward-looking travel demand intelligence with advertising planning, activation and AI-supported decision-making. This enables travel brands to drive profitable demand and decisions by investi
Kinaxis Convenes Global Supply Chain Leaders at Kinexions North America to Advance Agentic AI and Decision Orchestration28.5.2026 14:00:00 EEST | Press release
Kinaxis® (TSX:KXS), a global leader in end-to-end supply chain planning and orchestration, is set to host Kinexions North America kicking off next week from June 1-3 at The Cosmopolitan of Las Vegas. The company’s flagship conference will bring together global supply chain, business and technology leaders for three days of product innovation, customer insights, and peer networking as Kinaxis continues to advance its focus on AI-driven decision making across the supply chain industry. This year’s event will spotlight how organizations are applying agentic AI and orchestration, moving beyond insight to execution, and increasingly from decisions to coordinated action. Speakers from global organizations including Merck, Bristol Myers Squibb, Unilever, British American Tobacco, Qualcomm, ExxonMobil, The Hershey Company, Scotts Miracle-Gro, and Veolia,will join Kinaxis executives to share how they are navigating disruption and improving operational outcomes. Kinaxis CEO, Razat Gaurav is set
Compass Pathways Elects Kathleen Tregoning to Board of Directors28.5.2026 13:30:00 EEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the election of Kathleen Tregoning to its Board of Directors at the annual general meeting of shareholders. Ms. Tregoning is expected to serve on the Compensation and Leadership Development Committee and the Nominating and Corporate Governance Committee. She brings extensive experience guiding biopharmaceutical companies through periods of growth and transformation, with expertise spanning corporate strategy, external affairs, public policy and patient access. “With two successful Phase 3 trials meeting the primary endpoint, a transformative clinical profile for COMP360, and a rolling NDA submission and review now underway, Compass is strongly positioned to make our goal of securing an FDA approval a reality. Compass is entering a stage where experience in external engagement, public policy, and patient access matters more
Alzprotect Announces FDA Clearance of IND for AZP2006 (Ezeprogind®) in Progressive Supranuclear Palsy (PSP)28.5.2026 13:28:00 EEST | Press release
Alzprotect today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for AZP2006 (Ezeprogind®) for the treatment of Progressive Supranuclear Palsy (PSP). FDA clearance permits the Company to begin clinical development of AZP2006 in the United States. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260526387210/en/ “FDA IND clearance is a pivotal step in our PSP program,” said Philippe Verwaerde, PhD, President & Chief science Officer. “We can now expand our clinical efforts in the U.S. to evaluate AZP2006’s potential to address PSP, a severe neurodegenerative disease with no approved disease-modifying therapies.” Dr. Artin Karapet, Chief Medical Officer, commented: “The FDA’s clearance of our IND for AZP2006 is a pivotal milestone, aligning U.S. and European regulatory pathways and enabling the initiation of rigorous clinical trials in the United Stat
LMR by IFF Inaugurates New Experimental Field in Grasse28.5.2026 12:00:00 EEST | Press release
LMR Naturals by IFF—a global leader in natural ingredients for perfumery, cosmetics and flavors—today inaugurated its new experimental field, Domaine des Naturels LMR. The field is dedicated to advancing research in natural ingredients, preserving Grasse’s agricultural heritage and expanding education in naturals. The inauguration, attended by Grasse Mayor Jérôme Viaud, a long-standing supporter of the perfume industry, underscores IFF and LMR’s ongoing commitment to the region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260527694524/en/ At Domaine des Naturels LMR, R&D experts research new natural species, variety breeding, cultivation methods and production techniques. “This inauguration reflects over two decades of continuous investment in Grasse and in naturals,” said Ana Paula Mendonça, president, Scent, IFF. “With Domaine des Naturels LMR, we are bringing together innovation, preservation and knowledge sharing to s
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