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
SES Launches Multi-Orbit Satellite Connectivity on Mexico’s Viva1.6.2026 21:00:00 EEST | Press release
SES, a leading space solutions company, and Viva, Mexico’s ultra low-cost airline, launched fast and reliable multi-orbit satellite inflight connectivity service on Viva’s Airbus aircraft, strengthening SES’s position as a leading provider of satellite-powered broadband inflight service in the Americas and around the world. “Viva’s passengers will soon benefit from reliable, multi-orbit satellite connectivity that will provide the same fast and dependable internet access they enjoy at home no matter where or when they fly. SES’ partnerships with growing airlines like Viva highlight how carriers throughout the Americas are leading the way when it comes to the most advanced connectivity. SES is the engine that powers inflight connectivity, a trusted partner that makes airline operations easier,” said Mike DeMarco, SES President of Mobility. A total of 60 A320s and 40 A321s are set to offer the SES solution in the coming years. With the youngest Latin American fleet of Airbus A320s and A3
Motive Powers Latin America’s Next Wave of Mobile Innovation1.6.2026 18:00:00 EEST | Press release
Motive, a global leader in entitlement and connected device & service management, joined operators and industry leaders at M360 LATAM in Mexico City, showcasing live deployments across the region's most consequential use cases: Satellite Direct-to-Device connectivity for unreachable geographies, end-to-end eSIM provisioning and visibility at scale, and SIM-based silent authentication replacing fraud-exposed SMS OTP. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260531906729/en/ Across landmark deployments with multiple Claro, Vivo, and Entel operations, Motive’s Entitlement Server (Motive ES) has moved from infrastructure component to regional growth engine. These deployments are citing measurable commercial growth, enabling streamlined eSIM provisioning, improved device onboarding experiences, and new revenue opportunities tied to digital services and secure identity. Powered by Motive ES, Entel Chile became the first mobi
Interactive Brokers Integrates AI into Client Portfolios – Informed by Agentic Technology, Controlled by the Client1.6.2026 17:00:00 EEST | Press release
Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced agentic trading through direct integration with Claude, one of the world's leading AI platforms. Available through the AI platform’s certified connector marketplace, the integration lets clients manage their accounts and access more than 170 global markets. "Interactive Brokers has used technology for over four decades to help investors make more informed decisions and interact more efficiently with markets," said Milan Galik, Chief Executive Officer of Interactive Brokers. "Investors are increasingly using artificial intelligence to research markets, analyze information and generate ideas. We believe the next logical step is to allow clients to securely connect AI tools directly to their brokerage accounts — whether they want a simple conversational interface, deeper portfolio analysis or the ability to develop and execute sophisticated trading strategies.” Clients can link their existing IBKR account thro
AIM Expands Life Sciences Supply Chain Capabilities and Hires New Partner, Thomas Ebel1.6.2026 16:01:00 EEST | Press release
AIM today announced the appointment of veteran pharma supply chain expert Thomas Ebel as Partner, effective June 15. Mr. Ebel brings more than 25 years of supply chain consulting experience at leading firms including CAMELOT, McKinsey, and Accenture, and will anchor a broader initiative to expand AIM’s end-to-end supply chain capabilities. According to Richard de Bakker, Statutory Director and Founder at AIM, the firm is significantly expanding its capabilities around “end-to-end” supply chain needs. “AIM is well known as a leader in supply chain development for launch, as well as optimization of existing supply chains — supporting clients in getting their finished products to patients,” said Mr. de Bakker. “We are now adding new capabilities in supply chain diagnostics and strategy, end-to-end planning optimization, supply reliability, and working capital optimization, among others. Combined with AIM’s established supply chain expertise, this expanded offering gives clients true ‘end-
Seoul Semiconductor's World-First 'HV Opto-Semiconductor' Powers Up Global Top 4 Automakers1.6.2026 16:00:00 EEST | Press release
Seoul Semiconductor Co., Ltd. (KOSDAQ: 046890), a global opto-semiconductor technology company, announced that its world's first High Voltage (HV) opto-semiconductor technology has entered mass production with four of the world's top automotive brands across the Americas, Europe, and Asia, with plans to expand supply to 10 models by the end of the year. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260601232986/en/ Comparison: Conventional 3V LED vs. Seoul Semiconductor 12V 'HV Opto-Semiconductor' (Figure: Seoul Semiconductor) The technology combines micro-scaled opto-semiconductor chips capable of 12V single-chip operation — as opposed to conventional 3V LEDs — with a high-voltage (HV) driver technology. This enables a reduction of more than 10% in the number of driver-related components used in hybrid and electric vehicles, while lowering power consumption by approximately 10%, contributing to cost reduction and simplific
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