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
ExaGrid Announces All Flash/SSD Tiered Backup Storage Solution22.1.2026 15:00:00 EET | Press release
ExaGrid®, the industry’s only Tiered Backup Storage solution with AI-Powered Retention Time-Lock (RTL) that includes a non-network-facing tier (tiered air gap), Auto Detect & Guard, delayed deletes and immutability for ransomware recovery, today announced that it is shipping an All Flash/SSD backup storage solution with a unique front-end Landing Zone and non-network-facing Repository Tier (tiered air gap) that stores all backup retention using advanced data deduplication. The new SSD appliances ship with ExaGrid software version 8. ExaGrid’s unique Landing Zone and scale-out architecture allow for significantly faster backups and restores, as well as scalability as data grows, versus other SSD products such as Dell Data Domain inline deduplication appliances with SSD or straight SSD from Pure Storage. Due to three years of software work and the extremely fast performance of SSD, ExaGrid’s new SSD appliance models require a much smaller Landing Zone than on its HDD systems greatly redu
Overall Survival Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer22.1.2026 15:00:00 EET | Press release
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that ROSELLA, the company’s pivotal Phase 3 trial of relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer, met its overall survival (OS) primary endpoint. In ROSELLA, patients treated with relacorilant in addition to nab-paclitaxel chemotherapy experienced a 35 percent reduction in the risk of death compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.65; p-value: 0.0004). The median OS for patients receiving relacorilant was 16.0 months, compared to 11.9 months for patients receiving nab-paclitaxel alone, a difference of 4.1 months. Relacorilant in combination with nab-paclitaxel was well-tolerated, consistent with its known safety profile. Importantly, the
Parse Biosciences Launches Workflow for Immune Repertoire and Transcriptome Analysis22.1.2026 15:00:00 EET | Press release
Parse Biosciences, the leading provider of accessible and scalable single cell sequencing solutions, today announced the launch of a fully integrated immune repertoire and whole transcriptome analysis workflow in its data analysis platform, Trailmaker™. The new functionality complements Parse’s existing portfolio of Evercode immune products to enable a full end-to-end workflow for researchers. Immunologists have lacked an integrated, purpose-built platform capable of connecting immune repertoire data with whole transcriptome single cell insights. As a result, interpreting clonal behavior, understanding functional cell states, and drawing meaningful biological conclusions has often required stitching together fragmented tools, custom code, or inconsistent visualization approaches. The new Trailmaker functionality directly addresses these challenges by providing an accessible, end-to-end immune profiling solution that brings repertoire and transcriptional information together in a cohesi
BitGo Holdings Celebrates its Debut as a Public Company on the New York Stock Exchange22.1.2026 15:00:00 EET | Press release
BitGo Holdings, Inc. (“BitGo”, the “Company”, “we”), the digital asset infrastructure company, today celebrates its debut on the New York Stock Exchange (“NYSE”) as a publicly traded company under the ticker symbol “BTGO”. Members of BitGo’s leadership team will be ringing the NYSE Opening Bell today at 9:30am ET. “Today marks a defining moment for BitGo,” said Mike Belshe, CEO and Co-Founder of BitGo. “Our entry into the public markets will enable us to further accelerate the financial system’s transition toward a transparent and credible digital asset economy, while continuing to deliver exceptional security, custody and liquidity solutions for our clients. We believe that the opportunity ahead is significant and that we are uniquely positioned to help institutions navigate the road ahead.” Belshe continued, “I am incredibly proud of the company we’ve built, and deeply grateful to our team for their hard work and dedication in reaching this milestone. As we take this next step into t
AMGTA Announces EOS as New Principal Member and Appoints Björn Hannappel to Board of Directors22.1.2026 14:59:00 EET | Press release
The Additive Manufacturer Green Trade Association (AMGTA) today announced that EOS has elevated its longstanding participation in the association to Principal Member. As part of this expanded leadership role, Björn Hannappel, Head of Sustainability at EOS, has joined the AMGTA Board of Directors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260121601881/en/ Björn Hannappel, Head of Sustainability at EOS, has joined the AMGTA Board of Directors. Principal Membership represents AMGTA’s highest level of engagement and is reserved for organizations demonstrating sustained leadership, strategic alignment, and a commitment to advancing sustainable and resilient manufacturing practices globally. As a Principal Member, EOS will take on an expanded role in shaping AMGTA’s strategic direction, governance, and industry collaboration initiatives. EOS is a world-leading technology supplier in the field of commercial 3D printing of meta
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