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
ClickUp 4.0's Craft & Quality is Available Today, Maximizing Human Productivity10.12.2025 20:26:00 EET | Press release
ClickUp today announced the launch of ClickUp 4.0, a groundbreaking release designed to end the chaos of work sprawl and usher in a new era of work. With a bold vision for the convergence of software, people, and AI, ClickUp 4.0 delivers a suite of powerful new features that empower teams to do their best work in one converged workspace. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251210712132/en/ A new era of ClickUp For years, organizations have struggled with fragmented workflows, siloed tools, and the constant friction of context switching. ClickUp 4.0 is the answer: a single, beautifully crafted workspace that brings together tasks, docs, goals, chat, and AI-powered automation. The result is a platform that not only saves time but also sparks creativity and collaboration at every level. “Software is converging - we always knew it would. And it's about time, because work sprawl is the silent killer of productivity," s
United First Partners Serves as Introducing Broker on Mayflower IPO, a UK Listed Acquisition Vehicle and Among the Largest Primary New Issues in London in 2025, Highlighting UFP’s Increasing Presence Across ECM10.12.2025 19:42:00 EET | Press release
United First Partners (“UFP”) is pleased to announce its role as Introducing Broker on Mayflower Acquisition Limited (“Mayflower”), which completed its IPO today, raising USD 500 million. The size of the capital raised places Mayflower among the largest London acquisition vehicles of recent years. The offering represents an important development for UFP’s expanding capital markets platform and reflects the firm’s increasing activity within Equity Capital Markets (ECM). About Mayflower Acquisition Limited Mayflower is a UK Listed Acquisition Vehicle, sponsored by TOMS Capital and JRJ Group, incorporated to unlock exits across a closely-held company universe, including long-held private equity assets and large family-owned businesses. Mayflower’s structure provides guaranteed capital to asset owners, offering a flexible liquidity solution and higher potential for transaction success, and highly aligned economics to investors, with a significant Sponsor commitment of USD 75m. Mayflower wa
Abu Dhabi Launches FIDA Cluster to Shape the Next Generation of Financial and Investment Solutions10.12.2025 19:21:00 EET | Press release
Abu Dhabi has launched the FinTech, Insurance, Digital and Alternative Assets (FIDA) cluster to accelerate the development of next-generation financial and investment solutions and expand the emirate’s role as a global capital hub. Spearheaded by the Abu Dhabi Department of Economic Development (ADDED) and the Abu Dhabi Investment Office (ADIO), the cluster is a core pillar of Abu Dhabi’s long-term economic diversification agenda. By 2045, FIDA is projected to contribute an additional USD 15.2 billion to Abu Dhabi’s direct GDP, generate 8,000 skilled jobs and attract at least USD 4.6 billion in investment, cementing the emirate’s position as a destination for innovative and resilient financial systems. FIDA brings together high-growth areas where technology, regulation and capital intersect, including fintech, digital assets, insurance, reinsurance and alternative investments. It aims to position Abu Dhabi as a preferred jurisdiction for global firms seeking to design, test and scale n
Xsolla Celebrates a Week of Industry Programming at The Game Awards With a New Brand Launch, Day of the Devs Participation, and GamesBeat Hollywood & Games 2025 Partnership10.12.2025 19:00:00 EET | Press release
Xsolla, a leading global video game commerce company that helps developers launch, grow, and monetize their games, today announced a unified lineup of programming during The Game Awards week in Los Angeles. Together, these initiatives showcase Xsolla’s commitment to bringing the community and ecosystem together to support creators, strengthen the relationship between games and their players, and enable games to reach more markets around the world. The week of activities includes its partnership with GamesBeat Hollywood & Games 2025, a featured role during Day of the Devs: The Game Awards Digital Showcase, Games for Love’s The Game Gala, and the unveiling of Xsolla’s refreshed brand identity. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251210688609/en/ Berkley Egenes – Chief Marketing & Growth Officer at Xsolla The brand refresh is the centerpiece of Xsolla’s presence throughout the week, reflecting Xsolla’s future-forward
Hanseo University Expands Aviation Training Program with New Frasca Flight Training Device10.12.2025 17:05:00 EET | Press release
Frasca International, Inc., a FlightSafety International company and leader in flight simulation, today announced that Hanseo University in South Korea is expanding its aviation program with a new Level 5 Cessna 172 Flight Training Device (FTD), the seventh Frasca device to join the university’s fleet. Hanseo University’s school of Aeronautical Science recognized by the Korean University Accreditation Institute as the nation’s first Specialized University for Training Professional Workforce Industries, continues to expand its state-of-the-art simulation capabilities with the acquisition of a Level 5 Cessna 172 FTD. The addition builds on a partnership with Frasca that has spanned more than two decades and further advances aviation education across Asia. “We were seeking simulators that provided both realism and reliability, and Frasca stood out immediately,” said Dr. HanSuk Jung, Vice President Aeronautics, Hanseo University. “Over the years, our partnership has become a deep and lasti
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