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
GasEntec Announces New Ownership Structure, Accelerating Next Phase of Global Growth10.9.2026 12:00:00 EEST | Press release
GasEntec Holdings Inc., a global LNG technology and assets company, today announced a new ownership structure designed to accelerate GasEntec’s next phase of growth and expand the commercialization of its proprietary LNG technologies and solutions. A consortium led by the Groupe Mimran has acquired a majority stake in GasEntec Holdings Inc., the US holding company, supporting GasEntec’s global growth. Under the new structure, GasEntec Holdings is the parent company of GasEntec’s South Korean operating business. Prior shareholders have exited in full. GasEntec’s customer relationships, contracts, engineering organization and ongoing global operations remain unchanged. GasEntec will continue to operate independently, with its technology development, engineering and operations centered in South Korea and an expanding commercial presence across global markets. The new structure provides GasEntec with additional capital and strategic resources to build on its history of LNG innovation and p
EUMETSAT Takes Control of MTG-I210.9.2026 10:30:00 EEST | Press release
EUMETSAT’s Mission Control Centre in Darmstadt, Germany, took over control of the newest addition to its fleet of meteorological satellites, Meteosat Third Generation Imager 2 (MTG-I2), on 9 September 2026, following the successful completion of its Launch and Early Orbit Phase (LEOP). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260909889951/en/ MTG-I2 in orbit MTG-I2 launched from Europe’s Spaceport in French Guiana on 27 August 2026 and has now reached its geostationary orbit, around 36,000 km above Earth. During LEOP, carried out for EUMETSAT by Telespazio, communications with the satellite were established, its solar arrays deployed and a series of precise manoeuvres brought it to its designated orbital position. The spacecraft has now been handed over to EUMETSAT’s flight operations teams. EUMETSAT, working with ESA and European industry, will now begin extensive calibration and validation activities to prepare the s
LUMI AI Factory Selects IQM's Staged Path to Europe's First Superconducting Quantum Computer With Logical Qubits10.9.2026 10:08:00 EEST | Press release
IQM Quantum Computers (Nasdaq: IQMX) today announced its upgrade path for a logical-qubit-capable quantum computer. The deployment to the LUMI AI Factory, led by CSC – IT Center for Science, will support R&D efforts toward fault-tolerant quantum computing and advancements in hybrid computing. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260910712470/en/ UMI AI Factory selects IQM's staged path to Europe's first superconducting quantum computer with logical qubits The system, named LUMI-IQ, is an integral part of the wider LUMI AI Factory initiative, and is jointly funded by the EuroHPC Joint Undertaking and the participating countries: Finland, Czechia, Norway, and Poland. LUMI-IQ will be hosted in CSC’s new data center in Kajaani, Finland. LUMI-IQ will be delivered in three steps: the first installation of an IQM Halocene H4 system in 2027 with 150 physical qubits and early quantum error correction capabilities. The syste
Cyviz and SWISS Create Flexible Collaboration Hub for Hybrid Work at Scale10.9.2026 10:00:00 EEST | Press release
Cyviz AS has delivered a flexible collaboration hub for Swiss International Air Lines Ltd. (SWISS), designed to support hybrid meetings, workshops, training, town halls, and internal events at scale. The project highlights how global enterprises are investing in reliable, intuitive, and versatile collaboration environments as hybrid work becomes embedded in day-to-day operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260910985990/en/ Inside the SWISS collaboration hub at their headquarters in Zurich Located at SWISS headquarters in Zurich-Kloten, Switzerland, the new collaboration hub demonstrates how enterprise collaboration spaces are evolving from traditional meeting rooms into strategic workplace infrastructure. Delivered by Cyviz, the environment supports a wide range of hybrid formats while making advanced room technology simple for everyday users. Designed to switch seamlessly between separate and combined ro
Nothing Cleans Like Oral‑B iO: The Electric Toothbrush That Cleans Deeper, Smarter and Better10.9.2026 10:00:00 EEST | Press release
Oral‑B, the #1 brand most used by dentists worldwide, today spotlights its most advanced brushing technology: the Oral‑B iO range. Powered by a unique 2-in-1 cleaning technology, iO is engineered to clean deeper into every gap, brush smarter with real-time pressure guidance, and deliver results that are clinically proven to be better. The proof is everything — and nothing cleans like Oral‑B iO. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260904320713/en/ Oral-B iO10 Most people know that an electric toothbrush outperforms a manual one — but not everyone knows why, or what makes one electric brush stand apart from another. Oral‑B iO makes the difference clear: deeper, smarter, better — everywhere. Cleans Deeper: The Technology Behind the Clean At the heart of iO is a unique 2-in-1 technology: ultra-precise round head rotations work together with bristle-generated micro vibrations to break down and remove plaque simultaneou
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