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
Canva Introduces Magic Layers, Turning Static AI Outputs Into Editable Designs11.3.2026 15:00:00 EET | Press release
Canva, the world's leading all-in-one visual communication platform, today unveiled Magic Layers, a new breakthrough technology that turns any flat design or image into something you can edit, refine, and remix to suit your vision. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260311951174/en/ Magic Layers is a new breakthrough technology that turns any flat design or image into something you can edit, refine, and remix to suit your vision. Generative AI has triggered a flood of visual content, but most of it remains locked in static image files. Even small changes can require starting over, with reprompts that can unintentionally alter the entire design. Powered by years of internal research and Canva’s growing investment in its AI development arm, Magic Layers ushers in a new era of editable content, where speed meets true creative control. Available in public beta today, it turns AI-generated content into a launchpad, no
Adtran plays key role in OIF’s OFC 2026 interoperability demo with FSP 3000 OLS, ZR+ coherent plugs and domain controller11.3.2026 15:00:00 EET | Press release
Adtran today announced it’s playing a key role in the OIF’s multi-vendor interoperability demo at OFC 2026. The showcase brings together 40 member companies, highlighting real‑world operation across open optical networks. It validates multi‑vendor 100Gbit/s, 400Gbit/s and 800Gbit/s ZR+ coherent pluggable transceivers operating over open line systems. Featuring Adtran’s FSP 3000 OLS, coherent ZR+ pluggable optics and Mosaic Network Controller, the setup extends previous years’ configurations to include C‑ and L‑band operation and multi‑layer domain control. Adtran’s 800Gbit/s ZR+ pluggables also feature in the OIF plugfest, reinforcing their role in large‑scale, multi-vendor environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260311198561/en/ Adtran’s open networking technology will be central to the OIF multi-vendor interoperability demo at OFC 2026. “Interoperability is the foundation that enables open optical netw
Xsolla Releases New Industry Report Identifying the Biggest Opportunities for the Future of Video Games for Developers11.3.2026 15:00:00 EET | Press release
Xsolla, a leading global video game commerce company, today released the latest edition of The Xsolla Report, timed to coincide with this week's activations and collaborations in San Francisco. This edition provides insights from working with thousands of studios to map out where the industry’s biggest opportunities are emerging. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260311021020/en/ Graphic: Xsolla The gaming industry remains extraordinarily vibrant, and the playbook for success is changing. Studios that are adapting their commercial strategies, embracing direct-to-player commerce, expanding into high-growth global markets, and leveraging AI to sharpen operations are pulling ahead and building businesses designed to thrive for years to come. "The economics of game development have and will continue to shift and evolve into the future. Budgets have expanded, player acquisition costs have surged, and traditional publ
SES Launches Cash Tender Offer11.3.2026 14:25:00 EET | Press release
THIS ANNOUNCEMENT RELATES TO THE DISCLOSURE OF INFORMATION THAT QUALIFIED OR MAY HAVE QUALIFIED AS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE MARKET ABUSE REGULATION (EU) 596/2014. NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN OR INTO OR TO ANY PERSON LOCATED OR RESIDENT IN, OR AT ANY ADDRESS IN, THE UNITED STATES OF AMERICA, ITS TERRITORIES AND POSSESSIONS (INCLUDING PUERTO RICO, THE U.S. VIRGIN ISLANDS, GUAM, AMERICAN SAMOA, WAKE ISLAND AND THE NORTHERN MARIANA ISLANDS), ANY STATE OF THE UNITED STATES OF AMERICA OR THE DISTRICT OF COLUMBIA (THE UNITED STATES) OR TO ANY U.S. PERSON (AS DEFINED IN REGULATION S OF THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE SECURITIES ACT)) OR IN OR INTO ANY JURISDICTION WHERE IT IS UNLAWFUL TO RELEASE, PUBLISH OR DISTRIBUTE THIS ANNOUNCEMENT (SEE “OFFER AND DISTRIBUTION RESTRICTIONS” BELOW). SES (the “Offeror”) announces today that it is inviting holders of its outstanding €625,000,000 Deeply Subordinated Fixed Rate Re
Thredd and Cross River to Accelerate Expansion into the US Market for Global Fintechs11.3.2026 14:01:00 EET | Press release
Thredd, the AI-first issuer processing platform, today announced a strategic alliance with Cross River Bank (“Cross River”), a technology infrastructure provider that offers embedded financial solutions. The relationship is designed to accelerate the entry of international fintechs into the United States. This collaboration leverages Thredd’s global expertise and technology stack with Cross River’s proprietary core infrastructure, established market leadership and regulatory expertise, creating a seamless pathway for innovative payment solutions to launch and scale in the U.S. As part of this agreement, Thredd becomes one of Cross River’s select strategic processing partners outside of the bank’s own stack. The arrangement enables Thredd to introduce a curated pipeline of high-potential fintech clients from various geographic regions*.1 In turn, Thredd’s clients benefit from Cross River’s proven ability to deliver compliant, scalable banking infrastructure and principal network sponsor
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