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
Charlotte Tilbury awarded CBE in the King’s Birthday Honours 202613.6.2026 00:31:00 EEST | Press release
Charlotte Tilbury CBE, sole Founder, President, Chairman and Chief Creative Officer of Charlotte Tilbury Beauty, has been awarded a Commander of the Order of the British Empire (CBE) in the King’s Birthday Honours 2026 for services to the beauty and cosmetics industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260612679101/en/ Charlotte Tilbury, founder, president, chairman and chief creative officer of Charlotte Tilbury Beauty, who has been awarded a CBE (Commander of the Order of the British Empire) in 2026 for services to the beauty industry and entrepreneurship. (Photo: Charlotte Tilbury team) This honour recognises Charlotte’s contribution to leading and building Britain’s most successful global beauty brand. She has played a defining role in revolutionising the beauty industry and driving economic growth of the UK beauty sector, which has expanded from approximately £17bn in 2013 to over £31bn today. Charlotte Til
IQM Appoints Barbara Venneman, Vanguard Board Director and Former Global Head of Deloitte Digital, to its Board of Directors12.6.2026 19:36:00 EEST | Press release
IQM Quantum Computers, the global leader in superconducting quantum computers, today announced the appointment of Barbara Venneman to its Board of Directors. Venneman deepens the Board's expertise in digital transformation, enterprise technology commercialization, and global business scaling as IQM expands its commercial footprint worldwide. Additionally, CEO and Co-founder Jan Goetz will replace Co-founder Juha Vartiainen as the Founder representative on the IQM Board. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260612650938/en/ IQM Appoints Barbara Venneman, Vanguard Board Director and Former Global Head of Deloitte Digital, to its Board of Directors Ms. Venneman joins the IQM Board of Directors following a distinguished career at the intersection of advanced technology, strategy, and business transformation. She most recently served as Global Head of Deloitte Digital and previously held senior global leadership roles,
DEWA Organises Second Agentic AI Retreat at Al Shera’a, World’s Tallest, Largest and Smartest Net‑Positive Government Building12.6.2026 18:08:00 EEST | Press release
HE Saeed Mohammed Al Tayer, MD & CEO of Dubai Electricity and Water Authority (DEWA),has emphasised that DEWA deploys the latest Agentic AI technologies, in line with the vision to enhance its leading role and reinforce Dubai’s position as the city of the future. He made these remarks during the Agentic AI Executive Retreat DEWA organised at Al Shera’a, its new headquarters, which is the world’s tallest, largest and smartest net-positive government building. The event was attended by the executive leadership team and key stakeholders in digital transformation and artificial intelligence (AI), as well as representatives from SAP and McKinsey. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260612633834/en/ DEWA organises second Agentic AI Retreat at Al Shera’a, world’s tallest, largest and smartest net positive government building (Photo: AETOSWire) In his speech, Al Tayer said that DEWA is guided by directives from the wise l
BeOne Medicines’ Foundational Hematology Franchise Leads Next Era of B-Cell Cancer Innovation at EHA 202612.6.2026 13:00:00 EEST | Press release
BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new data from its foundational hematology franchise at the 2026 European Hematology Association (EHA) Congress in Stockholm. Updated results from tacabrutideg (BGB-16673), a potential best-in-class Bruton’s tyrosine kinase (BTK) degrader, demonstrated durable responses in pretreated relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), with early activity also seen in BTK inhibitor–naïve patients. These data are complemented by results from the all-oral combination of BRUKINSA® (zanubrutinib) plus next-generation BCL2 inhibitor BEQALZI™ (sonrotoclax; ZS), which continue to demonstrate rapid, deep, durable responses across multiple B-cell malignancies. Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said: “BTK inhibition has reshaped the treatment of B-cell cancers, and we believe degradation is the next leap forwa
Cyviz: Microsoft’s Immersive Approach to Collaboration12.6.2026 10:00:00 EEST | Press release
Watch Video Case Study >> This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260612831180/en/ Watch Video Case Study >> https://www.cyviz.com/case-studies/microsoft-immersive-suite/ As business and technology environments grow more complex, establishing shared understanding across disciplines has become critical. The Immersive Suite is designed for active collaboration, where visual narratives, data, and technical content are explored interactively. This allows participants to test scenarios, align perspectives, and move more efficiently from discussion to decision. “We deliberately work with familiar tools like PowerPoint. That allows us to focus on storytelling and interaction rather than explaining technology, making collaboration more natural and effective,” says Joris Haverkort, Chief Technology Officer for Microsoft Netherlands. A key principle is simplicity at scale. Instead of relying on specialized tools, users build co
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