numares announces FDA 510(k) Submission of AXINON System®, a NMR platform for metabolomics-based, AI-driven Diagnostics
24.3.2021 14:00:00 EET | 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/
numares AXINON® IVD System: The AI-driven AXINON® Software, in combination with advanced NMR technology, refined by numares' proprietary Magnetic Group SignalingTM, allows metabolomics-based precision diagnostics by implementation of various numares' tests, e.g. to identify early kidney rejection in post-transplant surveillance, assess kidney function by improved determination of glomerular filtration rate (GFR) and risk for cardiovascular disease (CVD). (Photo: Business Wire)
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/
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/20210324005057/en/
Contact information
numares
Christiane Proll
Tel.: +49 941 280 949-14
E-Mail:
christiane.proll@numares.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
83% of Restaurants Are Invisible in AI Search: New Uberall Report Reveals the Discovery Gap Reshaping the Quick Service Restaurant Industry7.5.2026 20:35:00 EEST | Press release
Uberall, the global leader in location marketing technology, today released Fast Food, Faster Discovery: The 2026 GEO Playbook for Multi-Location QSRs — the industry’s first benchmark report measuring how AI assistants recommend restaurants and how multi-location QSR (Quick-Service Restaurant) brands can adapt their local marketing strategies for AI-mediated search. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507962493/en/ Fast Food, Faster Discovery: Why AI Is the New Drive-Thru The report draws on Uberall’s proprietary GEO Studio benchmark data and aggregated performance metrics from its global QSR customer base. Its central finding: as consumer restaurant discovery rapidly shifts from traditional search to AI assistants, the majority of QSR locations are effectively absent from AI-generated recommendations — at the exact moment AI is becoming consumers’ primary discovery channel. This visibility gap arrives as the Q
Department of Health - Abu Dhabi and ŌURA Partner to Advance Preventive Health in Abu Dhabi7.5.2026 19:57:00 EEST | Press release
Department of Health—Abu Dhabi (DoH) and ŌURA, maker of the world’s leading smart ring, Oura Ring, today announced a joint research programme to study how continuous wearable data can advance preventive health. The collaboration marks the beginning of a long-term partnership to advance Abu Dhabi’s prevention-first, data-driven healthcare agenda, and will initially focus on women’s health and cardiometabolic risk. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507073495/en/ HE Mansoor Al Mansoori (Left) and Tom Hale (Right) The collaboration builds on Abu Dhabi’s advanced public health infrastructure and longitudinal health data assets, integrating them with ŌURA’s real-time, continuous insights across key health indicators. Together, this creates a strong foundation for understanding health at a population level, enabling the identification of risk factors and supporting a shift from reactive care to more proactive, perso
Rave Sues Apple in Five Countries Over App Store Removal7.5.2026 18:03:00 EEST | Press release
Rave Inc. (“Rave” or the “Company”), the developer and operator of the Rave app, a cross-platform co-viewing “super app” with more than 225 million downloads, today announced that it has filed antitrust lawsuits against Apple in five countries: the United States, Canada, Brazil, the Netherlands and Russia. The lawsuits challenge Apple’s unilateral and anticompetitive decision to remove Rave from its App Store, thereby distorting competition, reducing consumer choice in co-viewing functionalities and increasing the costs to users of switching between iPhone and competing smartphone devices. Rave operates a social entertainment app that allows users in different locations to watch their favorite videos, movies, and TV shows together in real time across multiple operating systems and devices, including iOS, Android, Windows and macOS, and communicate through chat and voice. Rave alleges that this cross-platform experience threatened Apple’s closed iOS ecosystem, which Apple maintains by l
emnify named a Visionary in the 2026 Gartner ® Magic Quadrant™ for Managed IoT Connectivity Services, Worldwide7.5.2026 18:00:00 EEST | Press release
emnify, a global provider of cloud-native IoT connectivity solutions, today announced it has been recognized as a Visionary in the 2026 Gartner® Magic Quadrant™ for Managed IoT Connectivity Services, Worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507642325/en/ emnify named a Visionary in the 2026 Gartner® Magic Quadrant™ for Managed IoT Connectivity Services, Worldwide. Get the report As a first-time recognized vendor, emnify believes this recognition reflects its forward-looking approach to IoT connectivity, building a platform designed to anticipate where enterprise needs are heading rather than replicating the connectivity models of the past. "We feel being named a Visionary in our first appearance in the Gartner® Magic Quadrant™ recognizes our deliberate strategy of the last decade: from owning our core network and pioneering satellite-cellular convergence on a single SIM, to embedding fine-tuned AI models
UAE Commits $49bn to Local Manufacturers7.5.2026 17:00:00 EEST | Press release
The United Arab Emirates (UAE) pledged $49 billion in industrial procurement opportunities on Monday and announced plans to localize more than 5,000 products as the Gulf state doubled down on its industrial sovereignty agenda. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507855698/en/ UAE commits $49bn to local manufacturers (Photo: AETOSWire) Dr. Sultan Al Jaber, UAE Minister of Industry and Advanced Technology, made the announcement at the opening of the fifth edition of Make it in the Emirates, which follows a period that has tested the region. “History remembers the challenges nations face. But it also remembers how nations respond to them and what they build next,” he said. TA’ZIZ announced $40.5 billion worth of agreements aimed at expanding UAE chemical production capacity. The opportunities include offtakes and $2 billion of financing for the UAE’s first world-scale methanol plant. A $270 million National Indust
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