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
Special Olympics Airlift Takes Flight Nationwide; Dove 1 Arrives at St. Paul Downtown Airport19.6.2026 18:09:00 EEST | Press release
The 2026 Special Olympics Airlift officially took flight today as all participating Cessna, Beechcraft and Hawker aircraft, known as Doves, departed from airports across the country. Dove 1 for arrival day, a Cessna Citation Latitude generously operated by Prent Corporation, landed at St. Paul Downtown Airport (STP) carrying Special Olympic athletes and delegation members, signaling the start of Airlift arrivals for the Special Olympics USA Games. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260619085293/en/ Special Olympics Airlift takes flight nationwide; Dove 1 arrives at St. Paul Downtown Airport (Photo credit: Textron Aviation). The arrival signals the start of the world’s largest cumulative peacetime airlift spanning more than 40 years, a coordinated aviation effort organized by Textron Aviation, a Textron Inc. (NYSE: TXT) company, that transports hundreds of Special Olympics athletes and coaches from multiple states
Record Currency Management Participates in Innovative European Bank for Reconstruction and Development (EBRD) -Backed Mongolian Tugrik Transaction19.6.2026 17:53:00 EEST | Press release
Record Currency Management Ltd (RCM), subsidiary of London-listed Record plc (Record Financial Group), is pleased to announce its participation in an innovative local currency bond transaction issued by the European Bank for Reconstruction and Development (EBRD), supporting the development of Mongolia's capital markets while providing institutional investors with access to attractive frontier market opportunities. RCM is the UK currency management arm of Record Financial Group, the London-listed specialist investment group managing USD 115 billion of assets on behalf of institutional clients worldwide. Record's client base comprises pension funds, foundations, sovereign institutions and other asset managers, with whom the Group has built long-standing relationships through its focus on bespoke investment and risk management solutions. Headquartered in London, Record has offices in Hamburg, Zurich, Zug, New York, and Hong Kong. The investment forms part of Record Financial Group's broad
Plasma One Launches to Herald a New Era of Stablecoin Banking19.6.2026 15:29:00 EEST | Press release
Plasma has today announced the launch of Plasma One, its flagship financial product designed to make digital dollars usable for everyday spending, sending and earning. Plasma One is designed to make stablecoins feel like money, only better - more accessible, reliable and efficient. For years, stablecoin adoption has been held back by a fragmented system and poor user experience. We have seen wallets in one place, exchanges in another, and costly off-ramps standing between digital dollars and daily life. Plasma One brings that experience together in a single app, giving users a simple way to spend, send and earn with stablecoins from one account with zero fees. Headquartered in London, the city that gave rise to Revolut, Wise and Monzo, Plasma is making a bigger bet, that the next generation of consumer banking will be built on stablecoin rails, not legacy banking infrastructure. Underneath Plasma One is the Plasma Network, Plasma’s own blockchain, purpose-built to move stablecoins inst
IQM Appoints Craig Ciesla, Former Illumina VP, as CTO; Inés de Vega Becomes Chief Scientist19.6.2026 10:00:00 EEST | Press release
IQM Quantum Computers, the global leader in superconducting quantum computers, today announced the appointments of Dr. Craig Ciesla as Chief Technology Officer (CTO) and Dr. Inés de Vega as Chief Scientist, as she transitions from her role as Vice President of Quantum Solutions, deepening IQM´s leadership as the company prepares for its planned Nasdaq listing through a merger with Real Asset Acquisition Corp. (Nasdaq: RAAQ). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260619693929/en/ From left to right: Dr. Inés de Vega, Chief Scientist, and Dr. Craig Ciesla, Chief Technology Officer. Ciesla, an experienced deep tech executive with more than 25 years delivering products across multiple industries from startups to Fortune 500 companies, will advance IQM's technology strategy and drive its implementation into systems and products. De Vega, meanwhile, will be responsible for ensuring scientific feasibility and system-level
Teijin Receives Approval for Additional Indications of XEOMIN ® for Cervical Dystonia and Blepharospasm in Japan19.6.2026 10:00:00 EEST | Press release
Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, and Merz Therapeutics GmbH, a leading player in neurology-focused specialty pharma, jointly announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the additional indications for XEOMIN® (incobotulinumtoxinA) for the treatment of cervical dystonia and blepharospasm. This approval represents the fourth and fifth indications for XEOMIN® authorized in Japan, alongside its existing approvals for the treatment of upper limb spasticity, lower limb spasticity and chronic sialorrhea. Cervical dystonia is a focal dystonia characterized by involuntary contractions of the neck muscles, resulting in abnormal or repetitive movements and postures.1 Blepharospasm is also a focal dystonia, characterized by excessive involuntary contractions of the muscles surrounding the eye.2 Both conditions significantly impact patients’ quality of life. The approval by MHLW is based on Phase III clinic
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