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
FIFA World Cup™ Fans Embrace Referee View as Lenovo AI Brings Viewers Closer to the Pitch9.7.2026 07:00:00 EEST | Press release
New international research from Lenovo reveals that technological advancements are fundamentally changing how fans experience the FIFA World Cup 2026™, making viewers feel closer to the action than ever before. According to a survey of football fans across Australia, Canada, India, U.K., U.S., 87% say technology is improving their viewing experience, and 84% report the close-to-action camera perspectives help them feel like they're right there on the pitch. Accelerating this unprecedented view of the game is Referee View, powered by Lenovo AI that gives viewers a first-person look at the match from the referee’s point of view. The research further found: Over three-quarters (76%) of FIFA World Cup™ viewers have seen or heard about Referee View, and 91% say the close-to-action perspective is appealing. 88% say that smooth, stable footage is an important part of viewing sports footage, and nearly all fans (98%) say clear picture quality has been important when watching this FIFA World Cu
Empire State Building Observation Deck Launches Exclusive Soccer Jersey Ticket Offer for Sports Fans in July9.7.2026 01:37:00 EEST | Press release
The Empire State Building Observation Deck (ESBOD) today announced a new, exclusive ticket offer for soccer fans who don their favorite team’s duds at the “World’s Most Famous Building” in anticipation of the tournament final. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708711923/en/ Empire State Building Observation Deck Launches Exclusive Soccer Jersey Ticket Offer for Sports Fans in July Guests who plan to wear their soccer jersey to the Empire State Building Observation Deck can purchase tickets online for 15 percent off to enjoy the immersive museum experience and New York City’s best views from the 86th and 102nd Floor Observation Decks. The limited-time offer is available only to guests who wear their soccer jersey on the day of their visit from now through July 31. “Whether they rep their favorite country’s jersey or the shirt from their hometown heroes, guests can celebrate their teams with prime views of the
New Esri Press Book Shows That GIS Can Transform the Entire Campus, Starting at the Classroom9.7.2026 00:33:00 EEST | Press release
Esri has released The Spatial Edge: The Strategic Advantage of GIS Skills Across Higher Education, a practical and accessible guide that demonstrates how geographic information system (GIS) technology can unify campuses academically and operationally. While GIS is often associated with disciplines such as geography, planning, and environmental studies, The Spatial Edge expands that view through real-world case examples. The book shows how spatial thinking can connect departments; strengthen decision-making; and help institutions address complex challenges across teaching, research, and campus operations. Designed for administrators, educators, and campus leaders, the guide highlights GIS being used across higher education to: Enhance teaching and student engagement Advance interdisciplinary research Improve campus planning and operations Strengthen community partnerships Prepare graduates with in-demand geospatial skills From the classroom to facilities management, The Spatial Edge ill
Jefferies Financial Group Inc. Announces Pricing of €850,000,000 4.500% Senior Notes Due 20338.7.2026 23:16:00 EEST | Press release
Jefferies Financial Group Inc. (NYSE: JEF) (“JFG”, “we” or “our”) today announced the pricing of its public offering of €850,000,000 aggregate principal amount of 4.500% Senior Notes due 2033 (the “Notes”) with an effective yield of 4.544%, maturing, July 15, 2033. The offering is expected to settle on July 15, 2026, subject to the satisfaction of customary closing conditions. Application is expected to be made for the Notes to be admitted to the Official List of the Irish Stock Exchange plc, trading as Euronext Dublin, and admitted to trading on the Global Exchange Market of Euronext Dublin; any listing is subject to approval by Euronext Dublin. JFG intends to use the net proceeds of the offering for general corporate purposes. Jefferies International Limited served as sole global co-ordinator and joint active book-runner for the offering of the Notes, Banco Santander, S.A., Citigroup Global Markets Limited, Natixis, SMBC Bank International plc and Société Générale served as joint act
KiddeFenwal Launches New Website and Information Hub8.7.2026 19:00:00 EEST | Press release
KiddeFenwal, the global leader in the fire suppression and safety controls industry, today unveiled a revitalized website, designed to serve as a comprehensive information hub for fire industry practitioners and customers alike. The modernized platform includes features created specifically with the company’s global partners, OEMs and distributors in mind, including: Accelerated asset navigation, pointing users to critical safety documentation, design parameters and product specifications; Seamless solution mapping, helping users quickly locate fire suppression configurations by industry, from data centers to BESS applications to commercial kitchens; and Enhanced resource access, including streamlined pathways to connect with the company’s elite distributor network across 120 countries. It also provides information about the company’s three brands, Kidde Fire Systems, Kidde Fire Protection and Fenwal Controls, replacing other sites serving customers in Europe and India. The launch of t
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