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
Unlocking Digital Gold’s US$700bn Opportunity19.10.2026 19:00:00 EEST | Press release
The digital gold market, worth US$45–55bn today, could unlock up to US$700bn in latent demand, according to new research from World Gold Council and Boston Consulting Group. The report points to substantial untapped appetite among retail investors, with nearly nine in ten surveyed saying they would consider digital gold under the right conditions. The US$700bn opportunity represents the report’s estimate of total latent demand that could be released if today’s barriers to adoption were removed, rather than a near-term forecast. The report’s five-year base case sees digital gold growing by around 27% a year to US$160–170bn by 2031. That could rise to US$270–280bn over the same time if more barriers fall faster. Momentum is already building as financial markets undergo a broader digital transformation, bringing tokenised investment products increasingly into the mainstream. Tokenised gold, one segment of the digital gold market alongside vaulted digital gold, has grown fivefold in value
Roquette Brings Broad Portfolio of Excipient Solutions and Technical Expertise to AAPS PharmSci 360 202619.10.2026 17:00:00 EEST | Press release
Roquette, a global leader in plant-based ingredients, excipients and pharmaceutical solutions, will showcase its expansive portfolio of excipients, capsules, coatings, and biopharma solutions at AAPS PharmSci 360 2026. The conference and trade show will take place October 26-28 in New Orleans, Louisiana, USA. At Booth 1100 in the exhibit hall, Roquette’s Health & Pharma Solutions team will share their expertise across controlled-release technologies, hydroxypropyl beta-cyclodextrins, and sustainable formulation approaches, alongside a comprehensive portfolio of innovative solutions designed to address the evolving needs of pharmaceutical developers. “AAPS PharmSci 360 is a key opportunity to share our latest innovations, as well as highlight the breadth and depth of our scientific know-how that helps our customers solve complex formulation challenges,” said Peter Freed, Head of Technical Service & Development North America for Roquette’s Health & Pharma Solutions Business Unit. “From a
TestGorilla Survey: Recruiters are Faster with AI, but Not More Confident They’re Finding the Right Candidates19.10.2026 16:00:00 EEST | Press release
AI made finding candidates faster for 72% of US recruiters over the last 12 months, according to TestGorilla's Recruiting in 2026 report, a survey of 1,428 US talent professionals. That speed, however, did not make them any more confident they had found the right person. In fact, of the recruiters that claim AI has made them faster, a third reported no gain in confidence at all, and 18% say their confidence in the match actually fell. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019723138/en/ Recruiters report gains in speed from AI but not in certainty - TestGorilla’s Recruiting in the AI era 2026 report Recruiters are making up the difference themselves, by hand. Of those recruiters, 67% now spend an hour or more manually checking a single candidate before they trust that person can do the job, and nearly 30% spend two hours or more. That is time AI sourcing was supposed to save, not divert to new, extra work. "Recrui
Fortanix Announces Confidential AI for Enterprise Grade Kubernetes Workloads on CNCF® Confidential Containers (CoCo)19.10.2026 16:00:00 EEST | Press release
Fortanix® Inc., a global leader in data and AI security and pioneer of Confidential Computing, today announced support for CNCF Confidential Containers (CoCo) in Fortanix Confidential AI, enabling organizations to run AI workloads on Kubernetes inside hardware-based Trusted Execution Environments (TEEs), on confidential CPUs and GPUs. Enterprises keep the speed and agility of containers while protecting sensitive data, AI models, agents, and applications in use, so they can support their regulatory compliance efforts, scale AI across the business, and adopt frontier AI without compromising data privacy or intellectual property. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019549928/en/ Confidential AI is a critical need in the industry today and a strong ecosystem of industry leaders is collaborating to advance open innovation and help enterprises securely adopt AI at scale. Regulated industries, including financial ser
Lenovo Earns Dual Leader Recognition for IT Sustainability in Latest ISG Provider Lens® Digital Sustainability Reports19.10.2026 16:00:00 EEST | Press release
Lenovo today announced that it has been named a Leader in the IT Solutions quadrant of the 2026 ISG Provider Lens® Digital Sustainability reports for both Europe and the United States, citing the company’s organization-wide approach to IT sustainability, which spans devices, infrastructure and services. The recognition comes as enterprises face the daunting challenge of scaling AI, balancing energy demand, and managing costs and environmental impact as infrastructure needs grow. ISG’s 2026 research estimates the global digital sustainability market to be $34.3 billion—up 12% from 2025. Europe represents 43% of that market, and the U.S. is 33%. Against the backdrop of growing year-over-year demand, Lenovo is broadening its approach to sustainability spanning circular procurement, AI-ready infrastructure, managed lifecycle services and carbon intelligence. Furthermore, Lenovo helps customers consider sustainability throughout the IT lifecycle, from procurement and deployment through oper
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