MA-NUMARES
24.3.2021 12:02:04 CET | 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/
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/
View source version on businesswire.com: https://www.businesswire.com/news/home/20210324005057/en/
About Business Wire
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
Andersen Global udvider sin afrikanske platform med tilføjelsen af medlemsfirma i Namibia9.5.2026 02:35:00 CEST | Pressemeddelelse
Andersen Global udbygger sin tilstedeværelse i Afrika med tilføjelsen af Andersen in Namibia, da Windhoek Advisory & Taxation tager Andersen-brandet til sig og styrker sine forudsætninger for at betjene virksomheder med aktiviteter i et af det sydlige Afrikas dynamiske vækstmarkeder. Andersen in Namibia har været et samarbejdsfirma siden 2021 og er en lokalt ejet revisions- og konsulentvirksomhed, der leverer ydelser inden for regnskab, skat og forretningsrådgivning, tilpasset de unikke behov i Namibias erhvervsklima. Med ekspertise inden for minedrift, landbrug, logistik, turisme og finansielle tjenesteydelser – sektorer, der er afgørende for Namibias økonomi – bistår firmaet både indenlandske virksomheder og internationale selskaber, der etablerer sig i regionen. Gennem cloudbaseret teknologi og datadrevet indsigt leverer Andersen i Namibia effektive og skalerbare løsninger, der gør det muligt for virksomheder at optimere deres drift, håndtere skatteforpligtelser på tværs af jurisdik
Andersen Consulting styrker sine kompetencer inden for organisatorisk transformation med Afiniti8.5.2026 20:45:00 CEST | Pressemeddelelse
Andersen Consulting annoncerer en samarbejdsaftale med Afiniti, et globalt konsulentfirma inden for forretningstransformation med hovedkontor i Storbritannien, der hjælper organisationer med at levere og opretholde komplekse forandringsprojekter. Afiniti blev stiftet i 2003 og er et globalt konsulenthus inden for forretningsforandring med base i Storbritannien og USA. De støtter klienter gennem komplekse transformationer på tværs af mennesker, processer, systemer og data, og de skaber mærkbare forandringer gennem kreative konsulentydelser. Virksomheden betjener primært stærkt regulerede, sikkerhedsdrevne og aktivtunge organisationer med store, geografisk spredte arbejdsstyrker inden for sektorer som energi, forsyning, biovidenskab, transport og byggeri. Afiniti samarbejder med velkendte brands om at levere ekspertise fra start til slut på tværs af organisatoriske, digitale og ai-baserede transformationer samt ændringer i kultur og driftsmodeller. Dette gælder især komplekse scenarier s
Verdantis Launches MRO360 “The World's First AI-Native Spare Parts Intelligence Platform”8.5.2026 15:40:00 CEST | Press release
MRO360 is the first milestone in Verdantis's journey to deliver the industry's first fully AI-native Enterprise Asset Management solution. Verdantis today announced the global launch of MRO360, a purpose-built AI platform that transforms how asset-intensive organizations manage their MRO spare parts inventory. Designed for manufacturers, oil and gas operators, mining companies, utilities, and other industrial enterprises, MRO360 deploys nine interconnected AI agents that continuously forecast demand, score parts criticality, manage obsolescence risk, calculate dynamic reorder points, helps intercompany plant transfer thereby realizing the exact dollar value of every optimization opportunity across a spare parts catalog in real time. Unlike traditional EAM and CMMS platforms built on static rules, MRO360's agents adapt continuously as demand patterns, supplier performance, and equipment health evolve. For the first time, a maintenance planner can see which work orders are at supply risk
Cyble Positioned as a Challenger in the 2026 Gartner® Magic Quadrant™ for Cyberthreat Intelligence Technologies8.5.2026 15:22:00 CEST | Press release
Cyble today announced it has been recognized as a Challenger in the 2026 Gartner® Magic Quadrant™ for Cyberthreat Intelligence Technologies. The company believes this recognition underscores Cyble’s mission to make threat intelligence truly operational—delivering AI-native capabilities that enable enterprises, government agencies, and MSSPs to shift from reactive security to proactive, intelligence-driven defense. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260508164528/en/ Cyble Named a Challenger in the 2026 Gartner® Magic Quadrant™ for Cyberthreat Intelligence Technologies "Security teams are under constant pressure to respond faster with greater accuracy," said Beenu Arora, Co-Founder and CEO, Cyble. "We believe this recognition highlights our focus on delivering intelligence that drives real outcomes—cutting through noise, accelerating response, and enabling confident decision-making at scale." Intelligence That Acts
WHOOP Expands Health Platform with On-Demand Clinician Access and New AI Features8.5.2026 15:00:00 CEST | Press release
New updates introduce a more personalized, data-driven member experience—bridging the gap between continuous biometrics, real-world context, and clinical insight WHOOP, the human performance company, today announced a new suite of health and AI-driven enhancements and feature updates across the WHOOP memberships, marking a major step forward in its evolution into an intelligent health platform. These updates deepen the company’s commitment to delivering highly personalized, accurate, and actionable insights. They signal the company’s expansion beyond performance optimization into clinical-grade health support. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260508464188/en/ WHOOP Expands Health Platform with On-Demand Clinician Access and New AI Features “WHOOP is a membership, and we take that seriously,” said Ed Baker, Chief Product Officer of WHOOP. “We’re always asking how we can deliver more value to our members, and the
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