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
The Bolivarian Republic of Venezuela Announces the Initiation of a Comprehensive Public Debt Restructuring Process13.5.2026 23:08:00 EEST | Press release
The Bolivarian Republic of Venezuela announces today its decision to initiate a comprehensive restructuring of its external public debt obligations. CONTEXT & RATIONALE Over the past decade, Venezuela's economy has been severely impacted by external shocks – from the end of the commodity super-cycle to foreign sanctions and COVID-19 – resulting in a sharp economic contraction, a protracted default since 2017, and a ballooning of public sector liabilities. The country nonetheless possesses a strong economic potential, including unique hydrocarbon and mineral endowments. A recovery is underway, and Venezuela is committed to accelerating it through a comprehensive reform agenda in support of growth, fiscal sustainability, monetary stabilization, and enhanced governance. Restoring public debt sustainability is central to this agenda: the current debt overhang constrains external financing, limits public investment capacity, and prevents full re-engagement with the international financial s
Boomi Announces Intent to Acquire Lunar.dev to Deliver Governed Agent Connectivity Across the Enterprise13.5.2026 22:00:00 EEST | Press release
Boomi, the data activation company for AI, today announced it has signed a letter of intent to acquire Lunar.dev, an innovator in AI and MCP gateway. The proposed acquisition is expected to enrich the Boomi Enterprise Platform and Boomi Connect with advanced capabilities to govern and scale AI usage across enterprise systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513850557/en/ Boomi Announces Intent to Acquire Lunar.dev to Deliver Governed Agent Connectivity Across the Enterprise As organizations move from AI experimentation to production, controlling how agents and AI applications interact with LLMs at scale has become critical. Lunar.dev addresses this need with an AI gateway that delivers granular, policy-driven control over AI interactions, with the visibility, security, and performance required for enterprise environments. These capabilities enable organizations to move from pilot to production with confiden
BeOne Medicines’ BEQALZI ™ (sonrotoclax) Approved by U.S. FDA as First and Only BCL2 Inhibitor for R/R Mantle Cell Lymphoma13.5.2026 20:27:00 EEST | Press release
BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to BEQALZI™(bee-KAHL-zee; sonrotoclax), a foundational, next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. BEQALZI was designed to enhance BCL2 inhibition—with greater potency, selectivity, and a pharmacologic profile with potential to improve efficacy, tolerability, and convenience over others in the class. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513542161/en/ BeOne Medicines' flagship U.S. biologics manufacturing and clinical R&D facility at the Princeton West Innovation Campus in Hopewell, N.J. Michael Wang, M.D., Global Principal Investigator
Boomi Unveils Innovations That Power the Agentic Enterprise13.5.2026 17:30:00 EEST | Press release
Boomi, the data activation company for AI, today announced a major expansion of the Boomi Enterprise Platform at Boomi World 2026, introducing new capabilities across orchestrated agentic workflows, agentic engineering, governed agent connectivity, grounded agent context, and localized agent infrastructure. Together, these innovations are designed to power the agentic enterprise — where agents and humans work together to drive action and operationalize AI at scale. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513996223/en/ Boomi Unveils Innovations That Power the Agentic Enterprise The enterprise has reached a defining moment as AI becomes the primary interface for work and MCP emerges as the new standard. While the shift toward a headless, agentic enterprise is inevitable, this vision is colliding with skyrocketing cloud costs and trapped data. For many, layering agents onto a fragmented landscape only magnifies govern
Boomi and Couchbase Partner to Power Enterprise AI Agents with Trusted Recollection, Connectivity, and Governance13.5.2026 17:30:00 EEST | Press release
Boomi, the data activation company for AI, and Couchbase, Inc., the operational data platform for AI, today announced a partnership through which the two companies are collaborating closely to accelerate AI pilots to production. The companies will co-engineer solutions that give customers a production-ready foundation for agentic AI, combining Boomi's connectivity, runtime, and governance for AI agents with Couchbase's scalable recollection and vector capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513350337/en/ Enterprises deploying AI agents today face a common challenge: while agents perform well in pilots, they struggle to scale due to inconsistent access to trusted context, recollection, and real-time business data. Lack of governance, auditability, and operational control drives up compute costs while diminishing productivity and revenue. “2026 is the year organizations move from AI experimentation to a
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