MA-NUMARES
24.3.2021 12:02:04 CET | Business Wire | Press release
Leading NMR diagnostics company numares AG today announced that the company made a 510(k) submission to the U.S. Food and Drug Administration (FDA) for its AXINON® IVD System , a NMR-platform for AI-driven, metabolomics-based diagnostics. If cleared, AXINON® would become the first NMR-based clinical laboratory system using AI-evaluated metabolic data. Several multi-marker assays for AXINON® will cover numerous unmet medical needs, in order to prevent, diagnose and treat disease.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210324005057/en/
The clearance of AXINON® would bring a novel diagnostic approach to clinical laboratories, the combination of several metabolic biomarkers, so-called metabolite constellations, analyzed by advanced nuclear magnetic resonance (NMR) technology and evaluated by numares’ proprietary, AI-driven AXINON® diagnostic software.
"This U.S. regulatory filing for its diagnostics platform is an important milestone for numares ," said Winton Gibbons, President - US and co-Chief Executive Officer of numares . “After entering into collaborations on joint diagnostics development with analytical instrumentation and solution provider Bruker Corporation in January 2021, and with Mayo Clinic Laboratories in 2019, this FDA submission is the first step in our common endeavor to bring NMR diagnostics into routine clinical use, and make metabolomics-based diagnostics accessible to the patients.”
numares is currently developing multi-marker algorithms for several diagnostic tests on the AXINON® IVD System . These include AXINON® GFRNMR to reliably assess kidney function by improved determination of glomerular filtration rate (GFR). numares expects to submit this test to the FDA also in the first half 2021. The third assay AXINON® renalTX-SCORE® is intended to reliably identify early kidney rejection in post-transplant surveillance, and be submitted to the FDA in 2022. Further multi-marker tests are in development, e.g., for liver disease, cancer detection, and multiple sclerosis.
Dr. Maulik Shah, numares’ Medical Director comments: “AXINON® provides clinical laboratories with a powerful technology that leverages the information-rich metabolome with artificial intelligence to give healthcare professionals new insights into disease diagnosis and management for improved patient outcomes. At the same time, automation capabilities, excellent precision, easy operability will allow easy adaption of the FDA-cleared system by clinical laboratories and will make AXINON® an indispensable routine diagnostic tool in precision medicine.”
“The 510(k) submission of our AXINON® System is an important step and prerequisite to further strengthen commercialization of numares’ products in the United States”, concludes Dr. Volker Pfahlert, co-CEO of numares and chairman of the executive board. “Metabolic disorders are a rapidly increasing problem and major challenge to today’s healthcare systems. Patients will benefit from our approach to consider the patient's metabolome with sophisticated algorithms. Once cleared by the FDA, we believe AXINON® has the potential to meaningfully improve health outcomes and quality of life for millions of patients.”
The AXINON® System consists of AI-based AXINON® Software , ready-to-use AXINON® kits, and an advanced NMR technology, refined by numares’ proprietary Magnetic Group SignalingTM to ensure highly standardized and automated processing of serum or urine samples in high-throughput.
About numares
numares AG, based in Regensburg, Germany, is a fast-growing innovative diagnostics company that applies machine learning to metabolomics data to develop advanced analytical tests for high-throughput use in clinical diagnostics. The AXINON® System employs advanced nuclear magnetic resonance (NMR) spectroscopy to evaluate metabolic constellations. Magnetic Group Signaling (MGS® ) is a proprietary technology that enables NMR for highly standardized and rapid throughput testing. Metabolic tests stand as an important pillar in precision medicine to address unmet needs in cardiovascular, kidney, liver, and neurological diseases. You will find more information at https://www.numares.com/
View source version on businesswire.com: https://www.businesswire.com/news/home/20210324005057/en/
About Business Wire
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
Data4Industry-X Empowers Industrial Organizations in Meeting Digital Product Passport Requirements20.4.2026 14:17:00 CEST | Press release
Contributing to the International Manufacturing-X Council Showcase at Hannover Messe, to improve resilience, productivity and innovation in Manufacturing Hannover Messe - Data4Industry-X, the trusted industry data space solution, builds its momentum by accelerating Digital Product Passport (DPP) compliance with trusted, secure and traceable data exchange at scale, as demonstrated at Hannover Messe April 20-24, 2026 . As theDigital Product Passport becomes a regulatory reality for manufacturing organizations, the ability to exchange data in a trusted, secure and traceable environment across the entire supply chain, in compliance with data regulations such as the Data Act, has become critical. Actively contributing to the International Manufacturing-X Council showcase, driven by LNI 4.0 association involving 16 countries, Data4Industry-X, a decentralized environment, demonstrates the use case of the DPP on the battery’s State of Health, and how the battery current capacity and performanc
Ushio Industry & Entertainment Appoints Takuya Matsumoto as President & CEO and Outlines Strategic Direction for the Next Phase20.4.2026 12:32:00 CEST | Press release
Ushio Industry & Entertainment (Ushio INE GmbH) announces the appointment of Takuya Matsumoto as President and Chief Executive Officer, marking a key milestone in the evolution of the business and its integration within the Ushio Group. With more than 20 years of experience across sales, new business development, and global operations, Takuya Matsumoto brings deep industry expertise and a strong leadership track record within Ushio. Most recently, he served as General Manager of the Global Business Unit, where he played a pivotal role in advancing global growth initiatives. A Clear Vision: A strong heritage with a forward-looking vision focused on innovation, operational excellence, and customer value Under Takuya Matsumoto’s leadership, Ushio INE will continue to build on its strong legacy while advancing its mission to deliver high-performance, high-quality lighting solutions across industrial and entertainment markets worldwide. “Our mission is to continuously deliver essential ligh
Compass Pathways to Participate in Needham Virtual Psychedelics Forum on April 27, 202620.4.2026 12:30:00 CEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that CEO Kabir Nath will participate in a panel entitled “Clinical Risk, Regulatory Reality and the Path to Scale” at the Needham Virtual Psychedelics Forum on April 27, 2026, at 11am-12pm ET. A live audio webcast of this event will be accessible from the “Events” page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event. About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable response
PPG invests in testing line for radiation-curable coatings at Marly, France20.4.2026 11:00:00 CEST | Press release
Installation helps accelerate development cycles, reduce number of customer trials PPG (NYSE: PPG) today announced the installation of an advanced testing line for radiation-curable coatings at its R&D Center of Excellence in Marly, France. The line can test multiple curing technologies, including infrared (IR), ultraviolet (LED, excimer and arc lamps), and electron beam (EB). This investment allows the company to accurately replicate customer production conditions, helping accelerate development cycles and reduce the number of customer trials. Unlike conventional thermal curing, radiation curing requires less energy because it operates at or near ambient temperature. This reduction in energy demand can significantly lower carbon emissions by 65%*, with further gains possible when powered by renewable energy sources. In addition, UV- and EB-curable systems typically use 100% solids formulations with no solvents, reducing or eliminating volatile organic compound emissions. Beyond sustai
IQOSand Devialet Introduce “Soundsorial Design” Collaboration20.4.2026 10:00:00 CEST | Press release
Exhibition and capsule collection drop at Milan Design Week 2026 Philip Morris International (NYSE: PM) today announced a collaboration between IQOS – the number 1 tobacco heating system1, and Devialet – the French acoustic engineering company, launching “Soundsorial Design” at Milan Design Week 2026. The immersive exhibition is an ethereal landscape of water and light, where sound, movement, and voice become visible across an ever‑changing immersive canvas. A space to push experiential boundaries, where visitors are invited to explore their own frequency as sound transforms into sight.The collaboration celebrates self-expression while connecting a community of over 35 million IQOS users who moved away from cigarettes. Devialet’s mission to give sound its rightful place in our lives, achieved through acoustic breakthroughs, meets IQOS’s bold spirit of being forever curious – the force that pushes the brand to continuously innovate and explore new technologies for a better future. Two p
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