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
Goldman Sachs Alternatives Acquires FGI Worldwide12.5.2026 12:00:00 EEST | Press release
FGI Worldwide LLC (“FGI” or the “Company”), a leading provider of working capital financing and trade credit insurance solutions, today announced it has been acquired by the Private Equity business within Goldman Sachs Alternatives. Over its 25-year history, FGI has established a strong reputation as a leader and innovator in asset-based lending and risk mitigation, specializing in multi-jurisdictional working capital solutions that support businesses with flexible financing to drive domestic and global expansion. The acquisition enables FGI to accelerate its growth and expand its suite of financing, risk and Insurtech solutions for clients. In conjunction with the transaction, Sami Altaher, Co-Founder and President of FGI, succeeds David DiPiero as Chief Executive Officer, marking the next chapter in the Company’s evolution. “We are grateful to our team, customers, partners and investors who have made this milestone possible,” said Altaher. “I am incredibly proud of what we have built
Kept Alive by ECMO Until Heart Transplant: Sahara Romero's Story of Survival and Recovery, with ECMOlife by Eurosets12.5.2026 11:45:00 EEST | Press release
“Now, for the first time in years, I can live without constantly fearing something could go wrong.” That's how Sahara Romero told her story, presented at the EuroELSO Congress in Dublin (6-8 May), dedicated to lifesaving extracorporeal therapies. Hers is a remarkable journey back to life, where clinical expertise and advanced life-support technologies came together to radically change her fate. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511305446/en/ Antonio Petralia, CEO of Eurosets; Sahara Romero, patient; dr. Mario Andrés Mercado Díaz, Intensive care specialist at the Clínica Shaio in Bogotá; Estefanía Giraldo Bejarano, specialist ECMO nurse at the Clínica Shaio in Bogotá Sahara has lived with a serious heart condition since early adolescence. The first signs of heart failure appeared when she was eleven. “When I was doing simple activities, like gymnastics lessons, I got very tired and experienced pain in my chest
New Research From Infobip Finds Disconnected Data and Systems Prevent Brands From Automating Customer Journeys at Scale12.5.2026 11:39:00 EEST | Press release
Global AI-first cloud communications platform Infobip’s 2026 Customer Experience (CX) Maturity Report reveals a widening gap between communications infrastructure investment and CX performance. With ever-increasing customer expectations, achieving CX maturity is the goal for major global brands. This hinges on how well brands can build experiences on mobile channels. There is a fundamental difference between a simple fraud alert on SMS and a two-way WhatsApp chat that allows customers to act immediately. While 96% of brands automate customer interactions in some way, few are delivering a seamless experience. Only 58% of brands say their channels are fully in sync, and 60% have centralized storage of customer data. But looking closer, only 27% use an orchestration platform, and 50% of brands say their tools are fully API-ready. This means half of brands struggle with connecting tools and data and many don't use a unified platform to build truly seamless experiences. This fragmentation i
Rerouting Alone Could Cost Airlines $8 Billion This Summer, New i6 Group Data Shows12.5.2026 11:00:00 EEST | Press release
Airlines flying European long-haul routes are facing a fuel cost penalty that could exceed $8 billion between May and August 2026, according to a new operational data report released today by i6 Group, a global leader in integrated aviation fuel management technology. The report, “Middle East Conflict: Summer 2026 Outlook,” draws on real fueling transactions captured at nearly 300 airports worldwide by i6's Fusion6 platform and provides insight into the costs of the conflict so far and how it might impact summer travel, based on actual fuel supply and into-plane uplift data. Key Findings $5.6 billion – $8.4 billion: Projected industry-wide rerouting fuel cost, May–August 2026 62.2%: Increase in European airport fuel book stocks (April 2026 vs. April 2025) 415,373 tons: Additional CO2 generated monthly from rerouting in the i6 network alone, or the equivalent of nearly 6,000 extra London–New York round-trip flights per month "The data captures what airlines are paying to fly around clos
Paymentology Raises $175 Million co-led by Apis Partners and Aspirity Partners to Support Next Phase of Growth12.5.2026 10:01:00 EEST | Press release
Paymentology, the leading global issuer-processor, today announced a $175 million investment co-led by Apis Partners (”Apis”), a private equity firm specialising in financial infrastructure and services, and Aspirity Partners (“Aspirity”), a pan-European Private Equity firm focused on Financial Technology & Services and Enterprise Technology & Connectivity Services. The investment will support Paymentology’s continued global expansion, product development and strengthening of its team, as the company builds on strong demand for modern issuer processing on a global scale. The transaction brings together two investors with deep experience in the payments industry and a shared focus on advancing payments infrastructure, united by the view that issuer processing represents one of the most significant opportunities in the sector. For Apis, the investment, made by Apis Growth Fund III1, marks the firm’s 16th payments investment. Both Apis and Aspirity will draw on their deep sector and globa
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