numares announces FDA 510(k) Submission of AXINON System®, a NMR platform for metabolomics-based, AI-driven Diagnostics
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
World Economic Forum and Salesforce Empower Global Leaders With First-of-its-Kind Agentic Assistant for the 2026 Annual Meeting in Davos15.1.2026 20:06:00 EET | Press release
Salesforce (NYSE: CRM), the world’s #1 CRM, today announced the activation of the World Economic Forum’s institutional knowledge powered by Agentforce 360 to support over 3,000 of the world’s most influential leaders at the 2026 World Economic Forum Annual Meeting. The Forum has launched a new proactive, high-precision concierge app, “EVA,” built on the Agentforce 360 Platform, Salesforce’s agentic platform. EVA will empower attendees to move beyond traditional information access, with an AI agent that doesn’t just answer questions, but can reason, prioritize, and act on a leader’s behalf for the 2026 Annual Meeting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260115571119/en/ Scheduled for January 19–23 in Davos, Switzerland, this year’s event is set to be the largest meeting in the organization's history. With over 450 high-impact sessions and thousands of specialized interactions, the gap between available insight and
Coolbrook Named on the 2026 Global Cleantech 10015.1.2026 19:14:00 EET | Press release
Coolbrook, a transformational technology and engineering company on a mission to decarbonise major industrial sectors like petrochemicals and chemicals, iron and steel, aluminium, and cement, has been named on Cleantech Group’s 2026 Global Cleantech 100. This annual list recognizes companies poised to deliver market-ready solutions that advance a cleaner, more resilient global future. The report highlights innovators addressing some of the world’s most urgent environmental and infrastructure challenges. The complimentary report introduces you to innovators advancing groundbreaking technologies and business models to enable us to act on the ever-increasing climate and environmental crisis. Following a 2025 marked by geopolitical volatility and shifting economic signals, the global cleantech ecosystem enters 2026 with slightly greater certainty - yet heightened competitive pressure. Growth is concentrating around two dominant themes: AI infrastructure and critical minerals. “The 2026 Glo
Frasca to Supply Four New Flight Training Devices to Global Medical Response15.1.2026 17:05:00 EET | Press release
Frasca International, Inc., a FlightSafety International company, today announced it has signed a contract with Global Medical Response (GMR) to supply four new Level 7 Flight Training Devices (FTDs). The new devices include an Airbus EC135, a Pilatus PC-12, a Beechcraft C90, and a Beechcraft B200. Each FTD will feature Frasca's unique motion system to provide enhanced realism in training. The devices will be installed at GMR’s new training facility currently under construction in Denton, Texas. Frasca has supported GMR’s pilot training efforts for nearly two decades, beginning with the delivery of their first device in 2005 for Air Evac Lifeteam, a GMR company. Since then, Frasca simulators have played a central role in preparing GMR’s flight crews for the complex and high-stakes environments they encounter in emergency medical operations. With the delivery of these new devices, GMR will operate a total of 15 Frasca simulators, including seven Level 7 FTDs and eight Helicopter Trainin
Andersen Consulting Expands Human Capital Offering With Addition of Jakarta Consulting Group15.1.2026 16:30:00 EET | Press release
Andersen Consulting deepens its capabilities through a Collaboration Agreement with Jakarta Consulting Group (JCG), an advisory firm known for its expertise in organizational transformation, human capital strategy, and leadership development. Headquartered in Indonesia, JCG has advised companies in industries such as real estate, mining, and manufacturing through strategic and cultural transformation. With core offerings that include business and management consulting, HR consulting, assessment, and business and management training, the firm is known for its ability to transform businesses and leaders with agility, cultural intelligence, and execution-driven solutions. “We’ve always believed that sustainable transformation begins with people — when leaders evolve, organizations follow,” said Patricia Susanto, CEO of Jakarta Consulting Group. “By combining Andersen Consulting’s global perspective with our regional insight, we can offer clients more holistic solutions to navigate change
illumynt Reports 60% Revenue Growth and Launches Global Innovation Center to Meet Rising Enterprise Security and Sustainability Demands15.1.2026 16:11:00 EET | Press release
illumynt an intelligent, security-first technology lifecycle partner, today announced significant growth and innovation milestones that position the company as a leader in the next evolution of the IT Asset Disposition (ITAD) industry—an industry increasingly shaped by artificial intelligence, accelerated hardware refresh cycles, and heightened regulatory scrutiny. Under the leadership of CEO Joerg Herbarth, illumynt continues to execute its mission to deliver intelligent, technology-driven lifecycle solutions that maximize sustainability, security, and recovery value for the world’s most compute-intensive organizations. In 2025, ITAD became a strategic imperative. AI-driven workloads have dramatically compressed infrastructure lifecycles, while updates to NIST SP 800-88 Rev. 2, adoption of R2v3, and the expansion of global privacy frameworks have raised expectations for auditability, transparency, and verified data security. As a result, ITAD has evolved from a back-end operational fu
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