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
Bureau Veritas: A Steady Organic Revenue Growth in the First Quarter 202622.4.2026 08:30:00 EEST | Press release
Bureau Veritas (BOURSE:BVI): Q1 2026 Key figures1 › Revenue of EUR 1,547.0 million, up 4.5% organically, and down 0.8% year-on-year › Strong organic growth from Marine & Offshore at +11.2% and Buildings & Infrastructure at +7.3% with moderate growth for Consumer Products Services at +4.3%, Certification at +2.3%, Agri-Food & Commodities at +2.1%, and Industry at +0.7%, › Stable scope effect of (0.1)%, from bolt-on acquisitions (+1.8% contribution), net of disposals (-1.9%), › Negative currency impact of 5.2%, resulting from the euro’s appreciation against most currencies. Q1 2026 Highlights › Maintained steady performance across most regions, in an environment marked by disruptions related to the conflict in the Middle East; growth in the Industry business impacted by the delays of Opex-related services mainly in the Middle East, › Continued progress in execution of the Group’s LEAP | 28 strategy, pivoting its portfolio towards higher‑growth and higher‑margin activities. Four acquisiti
Bureau Veritas: A Steady Organic Revenue Growth in the First Quarter 202622.4.2026 08:30:00 EEST | Press release
Bureau Veritas (BOURSE:BVI): Q1 2026 Key figures1 › Revenue of EUR 1,547.0 million, up 4.5% organically, and down 0.8% year-on-year › Strong organic growth from Marine & Offshore at +11.2% and Buildings & Infrastructure at +7.3% with moderate growth for Consumer Products Services at +4.3%, Certification at +2.3%, Agri-Food & Commodities at +2.1%, and Industry at +0.7%, › Stable scope effect of (0.1)%, from bolt-on acquisitions (+1.8% contribution), net of disposals (-1.9%), › Negative currency impact of 5.2%, resulting from the euro’s appreciation against most currencies. Q1 2026 Highlights › Maintained steady performance across most regions, in an environment marked by disruptions related to the conflict in the Middle East; growth in the Industry business impacted by the delays of Opex-related services mainly in the Middle East, › Continued progress in execution of the Group’s LEAP | 28 strategy, pivoting its portfolio towards higher‑growth and higher‑margin activities. Four acquisiti
4Moving Biotech Granted FDA Fast Track Designation to 4P004, Supporting an Accelerated Development Pathway in Knee Osteoarthritis22.4.2026 08:00:00 EEST | Press release
4Moving Biotech (4MB), a clinical-stage biotechnology company developing next-generation Disease-Modifying Osteoarthritis Drugs (DMOADs), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to 4P004 for the treatment of knee osteoarthritis in patients with synovitis who have not benefited from at least two prior pharmacological therapies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260421591087/en/ 4Moving Biotech Granted FDA Fast Track Designation to 4P004, Supporting an Accelerated Development Pathway in Knee Osteoarthritis This designation highlights both the serious burden of knee osteoarthritis and the persistent lack of disease-modifying treatment options. It also reflects the strong scientific rationale supporting the 4P004 development program, including its targeted intra-articular approach and the role of synovitis as a key marker of disease progression. 4P004 is a
4Moving Biotech Granted FDA Fast Track Designation to 4P004, Supporting an Accelerated Development Pathway in Knee Osteoarthritis22.4.2026 08:00:00 EEST | Press release
4Moving Biotech (4MB), a clinical-stage biotechnology company developing next-generation Disease-Modifying Osteoarthritis Drugs (DMOADs), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to 4P004 for the treatment of knee osteoarthritis in patients with synovitis who have not benefited from at least two prior pharmacological therapies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260421591087/en/ 4Moving Biotech Granted FDA Fast Track Designation to 4P004, Supporting an Accelerated Development Pathway in Knee Osteoarthritis This designation highlights both the serious burden of knee osteoarthritis and the persistent lack of disease-modifying treatment options. It also reflects the strong scientific rationale supporting the 4P004 development program, including its targeted intra-articular approach and the role of synovitis as a key marker of disease progression. 4P004 is a
LTM Wins Two Google Cloud Partner of the Year Awards for 202622.4.2026 05:30:00 EEST | Press release
LTM, the Business Creativity partner to the world’s largest enterprises, announced today that it has received two Google Cloud Partner of the Year 2026 Awards. LTM is being recognized for its achievements in the Google Cloud ecosystem, helping joint customers to drive high-impact, scalable cloud transformations. LTM won the Google Cloud Partner of the Year Award in the Media & Entertainment category by modernizing a global media company's complex data estate with BigQuery. The transformation improved speed, lowered costs, and provided a scalable foundation, enabling real-time analytics and AI-ready pipelines. This approach offers a repeatable model for data modernization in Media and Entertainment industry. Additionally, LTM was honoured with another Google Cloud Partner of the Year Award for Infrastructure Modernization in North America and the transformation of the ERP landscape for a global leader in healthcare services. This resulted in faster time to market, modern scalable ecosys
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