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
Hitachi and Google Cloud Expand Strategic Alliance to Accelerate Real-world Deployment of Physical AI Through FDE and Advanced Cybersecurity Solutions9.6.2026 03:20:00 EEST | Press release
Hitachi, Ltd. (TSE:6501, "Hitachi") today announced the expansion of its strategic alliance*1 with Google Cloud to support customers by accelerating the real-world deployment of physical AI and cybersecurity solutions to protect against AI generated threats. Garnering increasing attention, physical AI is a technology that connects AI-driven analysis and decision-making—derived from frontline data—to concrete actions such as autonomous control and operation of various devices and equipment. Continuously repeating this cycle enables optimal AI decision-making and execution tailored to each specific situation. Through the real-world deployment of physical AI, Hitachi is driving the transformation of social infrastructure. To realize this critical mission, through the strategic alliance, Hitachi will establish and globally deploy Hitachi's Forward Deployed Engineers (FDEs) model that leverages its strengths in IT, OT, and products cultivated through Lumada, together with Google Cloud’s adv
VeriSilicon Drives Commercial Adoption of AV2 Across Next-Generation Video and Streaming Applications9.6.2026 03:00:00 EEST | Press release
VeriSilicon (688521.SH) today announced that its VC9800D Video Processing Unit (VPU) IP supports AV2 decoding, further expanding the company’s advanced video codec portfolio for next-generation video and streaming applications. The VC9800D enables flexible deployment of next-generation video technologies across a broad range of intelligent consumer and multimedia devices. VeriSilicon has released VC9800D with AV2 to multiple global customers and is updating the IP based on the AV2 V1.0 specification. AV2 is the next-generation video coding specification from the Alliance for Open Media (AOMedia). Building on the foundation of AV1, AV2 is engineered to provide superior compression efficiency, enabling high-quality video delivery at significantly lower bitrates. It is optimized for the evolving demands of streaming, broadcasting, and real-time video conferencing. VeriSilicon’s VC9800D provides highly configurable video processing capabilities, supporting either standalone AV2 decoding or
ClickHouse Appoints New Leader for Asia Pacific and Expands Global Go-To-Market Leadership Team9.6.2026 01:45:00 EEST | Press release
ClickHouse, a leader in real-time analytics, data warehousing, observability, and AI/ML, today announced a significant expansion of its global go-to-market (GTM) leadership team, headlined by the appointment of Ed Lenta as Vice President, Asia Pacific and Japan (APJ). The additions build on the momentum established last year with the appointment of Kevin Egan as Chief Revenue Officer, and reflect ClickHouse's strategic investment in scaling its global organization to meet surging customer demand. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260608754768/en/ Ed Lenta, Vice President, Asia Pacific and Japan (APJ), ClickHouse Lenta joins ClickHouse to lead the company's go-to-market efforts across the APJ region. He brings deep experience scaling cloud and data platform businesses across the region, most recently as General Manager of Asia Pacific and Japan at Databricks, where he managed operations across more than twenty co
Money20/20 Europe Celebrates Ten Years of Industry Leadership as AI, Digital Assets and Financial Sovereignty Take Centre Stage8.6.2026 18:37:00 EEST | Press release
Money20/20, the world's leading fintech show and the place where money does business, celebrated a major milestone with its 10th Europe edition, convening more than 7,500 attendees, one in three at C-suite level, and over 2,300 companies from over 105 countries in Amsterdam, for three days of industry-defining announcements, strategic partnerships, and dealmaking that set the agenda for the future of financial services. Featuring more than 450 speakers across six stages, Money20/20 Europe welcomed leaders from banking, fintech, payments, policy, technology and digital assets to explore the forces reshaping the future of money. “This year’s show demonstrated that financial services have entered a new phase of transformation,” said Bryony Naylor, Vice President of Money20/20 Europe. “Across the show floor and on stage, we saw leaders move beyond discussing what’s next to actively building it. From AI and digital identity to financial sovereignty and digital assets, the conversations and
Liberty Latin America Selects BTS as Exclusive A2P Messaging Managed Services Partner Across All Its Markets8.6.2026 18:36:00 EEST | Press release
BTS announced today that it has been chosen as the exclusive provider of managed A2P SMS services for Liberty Latin America (LLA), supporting the company’s efforts to strengthen revenue protection, fraud mitigation, traffic intelligence, and operational visibility across its markets. The agreement reinforces LLA’s A2P messaging strategy throughout a broad regional footprint and establishes a coordinated operating model to improve control, visibility, and monetization of A2P traffic across its markets. The partnership will support revenue maximization, stronger fraud protection and grey-route mitigation, enhanced real-time traffic visibility, operational reporting and analytics, revenue assurance, and 24x7x365 managed services support. The agreement spans 25 markets and reflects a high level of operational trust in BTS’ ability to deliver consistent performance across diverse regulatory, technical, and commercial environments. “This agreement gives us a stronger and more consistent oper
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