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
Rimini Street Announces Fiscal Second Quarter 2026 Financial and Operating Results30.7.2026 22:03:00 CEST | Press release
Second Quarter Financial Highlights Include: Revenue of $111.1 million, up 6.7% year over year Adjusted Revenue of $108.0 million, up 10.0% year over year Remaining Performance Obligations (RPO) of $636.9 million, up 8.0% year over year Adjusted Annualized Recurring Revenue of $401.1 million, up 8.1% year over year Rimini Street, Inc., (Nasdaq: RMNI), a global provider of end-to-end enterprise software support, managed services and Agentic AI ERP innovation solutions, and the leading third-party support provider for Oracle, SAP and VMware software, today announced results for the fiscal second quarter ended June 30, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730702735/en/ Rimini Street Announces Fiscal Second Quarter 2026 Financial and Operating Results “Second-quarter results and four consecutive quarters of improved growth metrics demonstrate strong demand for our core Rimini Support™ offering, increasing adop
Rimini Street Launches Rimini Govern™ for AI to Deliver Comprehensive AI Agent Governance, Security & Interoperability as a Service30.7.2026 22:01:00 CEST | Press release
The new service enables organizations to quickly and easily implement and operationalize a global, enterprise-wide governance, control, security and performance measurement solution for AI agent activity and workflows Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced the immediate availability of Rimini Govern™ for AI, the newest offering in the company’s Rimini Govern portfolio of Governance, Risk and Compliance (GRC) solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730389723/en/ Rimini Street Launches Rimini Govern™ for AI to Deliver Comprehensive AI Agent Governance, Security & Interoperability as a Service The new managed service is delivered 24/7/365 through Rimini Street’s Global Command Centers by expert AI engineers to help organizations: Accelerate AI agent deployment Reduc
One Biosciences Announces Data Validating New Method for Single-Cell Transcriptomic Tumor Profiling from Clinical Pathology Samples30.7.2026 21:03:00 CEST | Press release
Sample-to-report workflow generating single-cell RNA expression profiles using routine FFPE pathology slides from four institutions validated across 88 specimens and six cancer types One Biosciences, a techbio company pioneering clinical-grade single-cell tumor profiling, today announced data establishing that single-cell RNA expression profiles can be generated from the standard, formalin-fixed paraffin-embedded (FFPE) pathology specimens obtained in routine cancer care using the company’s proprietary platform, OneMap™. The study, conducted with collaborators at Centre Léon Bérard, Hôpital Bichat–Claude Bernard, Institut Curie, and Memorial Sloan Kettering Cancer Center, was released as a preprint on BiorXiv. “Every tumor is a unique ecosystem of many different types of cells, some cancerous, some not. Single cell profiling enables us to understand what those cells are, what they’re doing and potentially how that may impact treatment outcomes,” said Helena Yu, MD, thoracic medical onc
ARIS Recognized as a Leader in First Gartner® Magic Quadrant™ for Digital Twin of an Organization Platforms, Believes This Reinforces Need for Trusted Governance and Control of Enterprise AI30.7.2026 18:00:00 CEST | Press release
ARIS, the process context platform enabling enterprise AI deployment, today announced its recognition as a Leader in the inaugural Gartner Magic Quadrant for Digital Twin of An Organization (DTO) Platforms – where it believes agentic AI, autonomous workflows, and enterprise governance converge. As enterprises move from AI experimentation to autonomous agent deployment, a critical challenge emerges: how do you safely scale autonomous AI when the enterprise lacks a unified digital twin – a single source of truth for processes, data, governance, and outcomes? Gartner describes the DTO as a dynamic software model that relies on operational and contextual data to understand how an organization operationalizes its business model, connects with its current state, responds to changes, deploys resources, simulates future states and delivers customer value. "Enterprises are rightfully ambitious about agentic AI and autonomous workflows," said Guillaume Bacuvier, CEO of ARIS. "But they're discove
Kingswood Capital Management Raises $4 Billion Across Two Oversubscribed Middle-Market Funds30.7.2026 17:00:00 CEST | Press release
The firm’s fourth institutional fundraise more than doubles its assets under management, reaching over $7 billion Kingswood Capital Management, L.P. (together with its affiliates, “Kingswood”), a Los Angeles-based investment firm focused on the middle-market, today announced the final closing of Kingswood Capital Opportunities Fund IV, L.P. (together with its parallel fund, “Fund IV”), with total capital commitments of $3.1 billion, as well as Kingswood Capital Opportunities Small Cap Fund I, L.P. (together with its parallel fund, “Small Cap Fund I”), with total capital commitments of $900 million. These funds more than double Kingswood’s total assets under management (“AUM”) to over $7 billion. Fund IV represents the fourth institutional fundraise in five years for Kingswood and is more than double the size of Fund III. Both Fund IV and the inaugural Small Cap Fund I were significantly oversubscribed in just five weeks. Fund IV exceeded its initial target of $2.25 billion, while Small
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