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
Octane AI Launches Phoenix, an AI Quiz Builder That Builds, Checks and Improves Quizzes for Shopify Brands21.10.2026 20:15:00 EEST | Press release
Octane AI, the quiz and zero-party data platform for Shopify brands, launched Phoenix in October, its biggest release to date. Merchants describe the quiz they want or upload what they already have, and Phoenix builds it, checks it, personalizes the results and keeps improving it with experiments. One beta customer turned a single document into a complete product-launch quiz: “I attached it to Phoenix, and it built the whole thing, all the pages. It understood everything, not just the text but the logic behind it.” Across all live Octane AI quizzes, 15% of shoppers who finish a quiz place an order. Yet building one has meant hours of writing rules by hand, custom code for design and clicking through every path to find broken results. Phoenix handles those hard parts, from building a quiz to improving it after launch. “Since day one, we've kept track of every piece of feedback from our merchants: what frustrates them and what they wish Octane AI could do. Phoenix is the result, and it k
Cognite Earns Corporate Supplier of the Year Award from Marathon Petroleum Corporation21.10.2026 20:06:00 EEST | Press release
Cognite today announced it has been named Corporate Supplier of the Year winner in Marathon Petroleum Corporation’s 11th Annual Supplier Recognition Awards. The Supplier Recognition Awards is a program sponsored by Marathon Petroleum Corporation to honor suppliers that positively impacted the company’s business throughout the previous calendar year. “There’s a reason ‘Impact’ is one of Cognite’s most important core values,” said Girish Rishi, CEO of Cognite. “For us, the ultimate measure of our performance is delivering quantifiable value for our customers. From that perspective, the Corporate Supplier of the Year award from Marathon is particularly meaningful. Marathon Petroleum is an innovator, and to receive this recognition is a great honor to the Cognite community.” The Supplier of the Year Award from Marathon is the latest honor Cognite has received in 2026: In May, Cognite ranked 15th on CNBC’s Disruptor50 list, honoring venture-backed companies innovating across industries, exp
The Estée Lauder Companies Inc. to Webcast Capital Markets Experience: China Ecosystem Immersion Presentations on November 4, 202621.10.2026 19:48:00 EEST | Press release
The Estée Lauder Companies Inc. (NYSE: EL) today announced that it will webcast presentations from its Capital Markets Experience: China Ecosystem Immersion in Shanghai, China, on Wednesday, November 4, 2026. The event will feature presentations from Stéphane de La Faverie, President and Chief Executive Officer, and Akhil Shrivastava, Executive Vice President and Chief Financial Officer, as well as members of the Company’s Executive Leadership Team and local leaders. The presentations will highlight the Company’s strategy and capabilities in China, Beauty Reimagined in action, and how China serves as a blueprint for deploying the Company’s global capabilities to drive sustainable growth and stronger profitability. Due to limited capacity, in-person attendance is by invitation only. Interested parties can access the live webcast on Wednesday, November 4th, beginning at 1:00 p.m. China Standard Time (12:00 a.m. ET) at Investors – The Estée Lauder Companies Inc. A replay of the webcast wi
Future Health and Bridge for Billions to Launch Programme Strengthening Health Entrepreneurship in Emerging Markets21.10.2026 18:50:00 EEST | Press release
Future Health – A Global Initiative by Abu Dhabi and Bridge for Billions will launch a new entrepreneurship programme designed to strengthen promising health ventures in emerging markets and help locally-developed solutions reach more people. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261021719421/en/ The first phase of the programme will target around 50 entrepreneurs leading late-incubation to early-acceleration ventures in Africa and Asia. Emerging markets are home to significant health needs and entrepreneurial potential, yet many promising ventures can struggle to access the capital, specialist guidance, and health-system connections required to grow. WIPO’s Global Innovation Index 2024 reported that Latin America and Africa together accounted for around 3% of global venture-capital deals in the first half of 2024, while venture-capital values fell by 19% in Asia-Pacific and 80% in Africa. At the same time, entrepre
Hephaestus Exits Stealth Having Raised $17.2M to Supply Rare-Earth-Free HTS Superconductors and Build Low-Cost Fusion Power21.10.2026 17:48:00 EEST | Press release
Hephaestus today emerged from stealth with solutions that address two of the largest cost drivers in fusion power: the high temperature superconducting (HTS) magnets that confine the plasma, and the edge-localized modes (ELMs – major plasma instabilities) that drive up the cost and complexity of conventional reactor designs. The company also announced the close of a new funding round led by CiRi Ventures. Hephaestus was founded in London in 2019 with a single mission – to help make fusion energy cheap enough to compete on the grid. Its AI plasma solver initially swept the full space of tokamak design parameters, unconstrained by the legacy designs and materials much of the industry is already committed to, and identified negative triangularity (NT), which inverts the D-shaped plasma used in most tokamaks, as the most likely configuration for low-cost fusion energy. Subsequent results from facilities worldwide, including the DIII-D, JET, and SMART, have shown that NT can deliver strong
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