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
Samsung and Mistral AI Announce Strategic Partnership for Intelligence-Driven Semiconductor Infrastructure8.9.2026 19:15:00 EEST | Press release
Samsung Electronics Co., Ltd., today announced it has entered into a strategic partnership with Mistral AI to enhance its semiconductor engineering and manufacturing capabilities that will reinforce its leadership in AI chip technologies. The announcement of the partnership was made during the state summit held in Paris between South Korea and France. Under the agreement, Samsung will integrate Mistral’s AI services and solutions—including its flagship large language model, Mistral Large—across its semiconductor operations to develop customized on-premises AI models optimized for intelligence-driven infrastructure. Mistral’s powerful AI platform is expected to provide Samsung with a unique stack of tools that will transform how semiconductors are designed and manufactured. The on-premises enterprise solutions will especially ensure security and flexibility required to process highly sensitive technologies and operational data entirely within the boundaries of Samsung’s semiconductor in
Sensereo Airo Wins IFA Berlin Innovation Award8.9.2026 18:00:00 EEST | Press release
Sensereo, an environmental intelligence company developing next-generation sensing products for safer, healthier and smarter living, was presented with the prestigious IFA Berlin Innovation Award for its Airo modular indoor air quality system. The award was presented during IFA Berlin on Thursday, Sept. 4, recognizing Airo for its innovative approach to helping consumers better understand and manage the quality of their indoor environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260906292649/en/ Winner of a 2026 IFA Innovation Award, Airo is Sensereo’s flagship environmental intelligence platform, combining advanced sensing technology with a modular design that allows users to monitor multiple aspects of indoor air quality and environmental conditions through a single, consumer-friendly system. Designed to transform complex environmental data into useful, actionable information, Airo helps households better understan
Verdantis Rebrands as the AI Super-Agent for MRO, Sets Sights on AI-Native Enterprise Asset Management8.9.2026 17:06:00 EEST | Press release
Verdantis, the AI company for spare parts and MRO inventory optimization in asset-intensive industries, today unveiled its new brand identity as the AI Super-agent for MRO and announced it is building toward a fully AI-native Enterprise Asset Management (EAM) platform. Verdantis’s super-agent orchestrates nine specialized AI agents across the decisions that decide plant uptime: spare parts, criticality, demand, reorder, and work order planning. These decisions set working capital, maintenance spend, and whether a critical asset runs and, in most plants, they are still made in spreadsheets and disconnected systems. The positioning is for the teams who own uptime - maintenance, reliability, and MRO supply chain leaders in oil and gas, mining, utilities, chemicals, and manufacturing. And it reflects an AI-first architecture: agents decide and act by default; people supervise, override, and teach the system. Every human override creates feedback that helps the system learn. That principle
HyperLight Welcomes VentureTech Alliance to Series C, Deepening TFLN Integration Across the Semiconductor Ecosystem8.9.2026 17:00:00 EEST | Press release
HyperLight Corporation ("HyperLight"), a leader in thin-film lithium niobate (TFLN) photonics, today announced that VentureTech Alliance ("VTA") has joined its Series C financing round. VTA is a venture investment firm focused on the semiconductor industry, with a portfolio built across the semiconductor technology stack — including circuit design, foundry-adjacent process technology, EDA, advanced packaging, and photonics. VTA's participation extends the ecosystem alignment that defined the round, which brought together investors spanning silicon ICs, foundry manufacturing, electronics manufacturing services, networking, and global infrastructure capital. With VTA's addition, the syndicate now reaches further into the semiconductor manufacturing and design-enablement layers on which high-volume photonics production depends. "The transition to TFLN is not a component decision — it is an ecosystem decision," said Mian Zhang, CEO of HyperLight. "Getting TFLN into volume requires the proc
EcoOnline Appoints Conor O’Loughlin as CEO8.9.2026 17:00:00 EEST | Press release
EcoOnline, a global provider of software that transforms how organisations protect people and the planet, today announced the appointment of Conor O’Loughlin as Chief Executive Officer, effective immediately. O’Loughlin succeeds Tom Goodmanson and will lead the Company into its next chapter of growth and innovation, continuing EcoOnline’s mission of keeping employees safe across the globe and supporting more than 11,000 customers. O’Loughlin is an experienced, growth-oriented technology operator and founder. He co-founded fitness technology company Glofox, scaling it into a global SaaS business serving customers in more than 80 countries before its acquisition by ABC Fitness in 2022. Following the acquisition, he served as Platform President and later Global Chief Revenue Officer at ABC Fitness, leading strategy across the company’s revenue-generating activities. “Keeping people safe at work is more important than ever, and EcoOnline does it with a depth of expertise that few can match
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