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
Seequent Launches AI-Powered Imago Image Analysis to Accelerate Geological Core Logging13.10.2026 15:00:00 EEST | Press release
Seequent, The Bentley Subsurface Company, has launched Imago image analysis, a new AI-powered capability built directly into its cloud-based solution Imago for extracting knowledge from geoscientific imagery. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261013282684/en/ Imago image analysis results showing core condition, fracture polylines, and AutoCrop boundaries on diamond-drilled core. Core condition delineates solid (blue), broken (orange), depth blocks (green), and gaps in recovered core. With the new Imago image analysis add-on, geologists can analyse drill core imagery in minutes, dramatically accelerating analysis that has traditionally taken days or weeks. It generates consistent, high-confidence quantitative geological data to support modelling and exploration decisions, helping teams from junior explorers to mining majors derive greater value from drilling programmes. Purpose-built machine-learning models autom
ExaGrid Announces Record 3 rd Quarter Bookings and Revenue13.10.2026 15:00:00 EEST | Press release
ExaGrid®, the world’s largest independent backup storage vendor providing Tiered Backup Storage with the fastest backups, fastest restores, largest backup storage scale-out system with deduplication, and the most comprehensive security and AI-Powered Retention Time-Lock for Ransomware Recovery, today announced that it had its best ever third quarter for bookings and revenue in the quarter ending September 30, 2026, with double-digit revenue growth over Q3 of 2025 and double-digit revenue growth for the first nine months of 2026 over 2025. ExaGrid has exceeded its plan in all three quarters of 2026 and is ahead of plan on its way to a record bookings and revenue year. ExaGrid’s growth rate is accelerating. In addition, ExaGrid remained P&L, EBITDA, and free cash flow positive for the 23rd consecutive quarter. The company is 100% debt-free, demonstrating strong financial health as a company. ExaGrid had its highest percentage of bookings coming from deals over $1M. Highlights of Q3 2026:
What Europeans Really Want From Their Next Smartphone13.10.2026 14:01:00 EEST | Press release
If you’ve ever bought running shoes for the runner you hoped to become or luggage for a yet to be planned trip, you’re not alone. New research from Samsung reveals that Europeans1 take a similar aspirational approach when choosing a smartphone. More than two thirds (66%2) of Europeans surveyed1 chose their current smartphone with at least one interest they wanted to pursue in mind, with interests ranging from entertainment and side hustles to gaming, travel and content creation. In fact, almost half (46%3) consider their ambitions when making technology choices, including 24% who say their choices are primarily shaped by the life they aspire to lead. Additionally, almost a third (28%) reported that they chose their current smartphone to better reflect their personal style. Having a variety of options to choose from is important when considering the wide range of aspirations and focuses of European consumers. Big ambitions, everyday needs Europeans1 may be choosing smartphones with futu
Enodia Therapeutics Announces Research Collaboration and License Agreement with Pfizer to Develop Sec61-Targeting Small Molecules13.10.2026 14:00:00 EEST | Press release
Enodia Therapeutics, a biotechnology company developing novel small-molecule therapies for targeted protein degradation at the point of synthesis, today announced it has entered into a research collaboration and license agreement with Pfizer Inc. to discover and develop Sec61 inhibitors. The collaboration aims to accelerate the discovery and advancement of novel small-molecule therapeutics leveraging Enodia’s proprietary platform. Enodia’s proprietary platform enables selective Sec61 Translocon modulation, a novel approach to inhibit disease-driving proteins at the point of synthesis before pathological effects occur, while preserving essential physiological functions. Enodia has built a broad and well-characterized chemical space spanning multiple Sec61 inhibitor families, supported by extensive biological datasets, including proteomics, cryo-EM and tailored cell-line libraries that enable rational small-molecule design powered by machine learning. “Enodia has built a broad platform t
TradingHub Appoints Phil Snow as Chairman13.10.2026 12:00:00 EEST | Press release
TradingHub today announced the appointment of Phil Snow as Chairman, further strengthening the company's leadership as it continues to expand its global presence and invest in innovation across trade surveillance. Phil brings three decades of experience in financial technology, data and analytics, built at FactSet, where he served as Chief Executive Officer from 2015 to 2025. Under his leadership, FactSet more than doubled its revenue, joined the S&P 500 and expanded its products and global presence. The appointment follows TradingHub's recent investment from Nordic Capital and reflects the shared ambition to support the company's next phase of growth while building on the strong foundations established by its leadership team. "Phil is an outstanding appointment for TradingHub, and I am delighted to welcome him as Chairman," said Mike Coats, Chief Executive Officer of TradingHub. "He spent a decade running a global financial data company that serves many of the same institutions we do,
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