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
ILiAD Biotechnologies Expands BPZE1 Public Health and Commercial Potential with Publication of Pediatric Phase 2b Study in The Lancet Infectious Diseases2.10.2026 15:00:00 EEST | Press release
ILiAD Biotechnologies, Inc. (ILiAD), an advanced clinical stage biotech company focused on the prevention and treatment of disease caused by Bordetella pertussis, today announced the publication of results from its Phase 2b SUPER (Stand Up to Pertussis) clinical trial in The Lancet Infectious Diseases. This randomized, double blind, placebo- and active-comparator-controlled trial demonstrated that BPZE1, a live attenuated intranasal pertussis vaccine, induced robust nasal mucosal immune responses in healthy children aged 6 through 17 years (LINK). The study demonstrated that a single intranasal dose of BPZE1 induced nasal mucosal immune responses against all Bordetella pertussis antigens tested and was well tolerated, both when administered alone and when co-administered with a tetanus-diphtheria-acellular pertussis (Tdap) booster vaccine. The multi-center Phase 2b trial enrolled 366 participants across 16 sites in the United Kingdom, Australia, and Costa Rica and included participants
NIQ Brings New AI and Automation Capabilities to Retail Space Planning and Merchandising2.10.2026 13:45:00 EEST | Press release
NielsenIQ (NYSE: NIQ), a leading consumer intelligence company, today announced new AI and automation capabilities for NIQ Spaceman®, its retail space planning and merchandising platform trusted by more than 600 retailers across 65+ countries. The enhancements help retailers create store-specific planograms up to 50 times faster, identify execution and compliance gaps, and scale merchandising decisions across their store networks through expanded cloud-based access. "Retailers are under increasing pressure to localize assortments, execute consistently across stores, and respond more quickly to changing shopper behavior," said Natalie Williams, SVP, Product at NIQ. "These enhancements help simplify that process by embedding agentic AI directly into merchandising workflows and automating traditionally manual planning tasks. That means teams can spend less time building and updating planograms and more time acting on opportunities. With greater automation, retailers can improve productivi
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)2.10.2026 13:30:00 EEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to one senior leader and ten newly hired non-executive employees. The equity awards for the senior leader were granted on September 30, 2026 and consisted of options to purchase an aggregate of 121,800 shares and restricted share units covering an aggregate of 58,000 shares. The options have an exercise price per share equal to $12.44. The equity awards to the ten newly hired non-executive employees were granted on October 1, 2026 and consisted of options to purchase an aggregate of 97,100 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 46,200 shares. These options have an exercise price per share equal to $11.95, the closing price of the Company’s American De
Global Health Leaders to Convene at Abu Dhabi Future Health Summit 20262.10.2026 13:24:00 EEST | Press release
Global leaders across healthcare, science, technology, policy, and investment will convene at the Abu Dhabi Future Health Summit from 20 to 22 October 2026 to examine how health systems can better anticipate risk and enable earlier intervention as advances in AI, genomics, diagnostics, and health data create new possibilities for understanding health risks earlier. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261001283179/en/ Forum panel and speakers at the Abu Dhabi Future Health Summit As health systems respond to the growing burden of chronic disease and the need to help people live longer in good health, the ability to identify changing health risks and act sooner is becoming increasingly important. Hosted by Future Health – A Global Initiative by Abu Dhabi and the Department of Health – Abu Dhabi, the Future Health Summit will be held under the theme 'To Sense is to Predict', exploring the global shift from reactive m
Venture Global and ConocoPhillips Announce 20-Year LNG Sales and Purchase Agreement1.10.2026 23:30:00 EEST | Press release
Today, Venture Global, Inc. (NYSE: VG) and ConocoPhillips (NYSE: COP) announced a new, long-term Sales and Purchase Agreement (SPA) for liquefied natural gas (LNG). Under the SPA, ConocoPhillips will buy 1.0 million tonnes per annum (MTPA) of LNG from Venture Global for 20 years, starting in 2030. "Venture Global is proud to welcome ConocoPhillips, one of the world's leading energy companies, as a long-term partner," said Venture Global CEO Mike Sabel. "This agreement reflects continued market confidence in our proven ability to deliver reliable, low-cost U.S. LNG quickly and at scale. We look forward to supporting ConocoPhillips' growing global LNG portfolio for decades to come." About Venture Global Venture Global is an American producer and exporter of low-cost U.S. liquefied natural gas (LNG) with over 100 MTPA of capacity in production, construction, or development. Venture Global began producing LNG from its first facility in 2022 and is now one of the largest LNG exporters in th
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