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
Vedanta Ltd Doubles Zinc Capacity in South Africa with US$ 600 Mn investment19.10.2026 20:19:00 EEST | Press release
Vedanta Limited doubled its annual zinc production capacity to 500,000 tonnes1in South Africa through an investment of nearly US$ 600 Mn at Gamsberg (Phase II) at Vedanta Zinc International (VZI). Gamsberg has one of the world’s most significant zinc deposits and is VZI’s flagship zinc mine. Inaugurated by South African President Cyril Ramaphosa and Vedanta Limited Director Priya Agarwal-Hebbar, this expansion marks one of the decade’s largest mining investments in South Africa. It advances Vedanta Limited’s position as the world’s largest2 zinc producer, with a vision of achieving 3 million tonnes of annual production across India and South Africa. Of this, 2 million tonnes are targeted from its subsidiary, Hindustan Zinc Limited the world’s largest integrated zinc producer, while Vedanta Zinc International business aims to contribute 1 million tonnes annually. This expansion strengthens the ZAR 21 Bn (nearly US$ 1.5 Bn) investment commitment Vedanta made at the 2018 South Africa Inve
Unlocking Digital Gold’s US$700bn Opportunity19.10.2026 19:00:00 EEST | Press release
The digital gold market, worth US$45–55bn today, could unlock up to US$700bn in latent demand, according to new research from World Gold Council and Boston Consulting Group. The report points to substantial untapped appetite among retail investors, with nearly nine in ten surveyed saying they would consider digital gold under the right conditions. The US$700bn opportunity represents the report’s estimate of total latent demand that could be released if today’s barriers to adoption were removed, rather than a near-term forecast. The report’s five-year base case sees digital gold growing by around 27% a year to US$160–170bn by 2031. That could rise to US$270–280bn over the same time if more barriers fall faster. Momentum is already building as financial markets undergo a broader digital transformation, bringing tokenised investment products increasingly into the mainstream. Tokenised gold, one segment of the digital gold market alongside vaulted digital gold, has grown fivefold in value
Roquette Brings Broad Portfolio of Excipient Solutions and Technical Expertise to AAPS PharmSci 360 202619.10.2026 17:00:00 EEST | Press release
Roquette, a global leader in plant-based ingredients, excipients and pharmaceutical solutions, will showcase its expansive portfolio of excipients, capsules, coatings, and biopharma solutions at AAPS PharmSci 360 2026. The conference and trade show will take place October 26-28 in New Orleans, Louisiana, USA. At Booth 1100 in the exhibit hall, Roquette’s Health & Pharma Solutions team will share their expertise across controlled-release technologies, hydroxypropyl beta-cyclodextrins, and sustainable formulation approaches, alongside a comprehensive portfolio of innovative solutions designed to address the evolving needs of pharmaceutical developers. “AAPS PharmSci 360 is a key opportunity to share our latest innovations, as well as highlight the breadth and depth of our scientific know-how that helps our customers solve complex formulation challenges,” said Peter Freed, Head of Technical Service & Development North America for Roquette’s Health & Pharma Solutions Business Unit. “From a
TestGorilla Survey: Recruiters are Faster with AI, but Not More Confident They’re Finding the Right Candidates19.10.2026 16:00:00 EEST | Press release
AI made finding candidates faster for 72% of US recruiters over the last 12 months, according to TestGorilla's Recruiting in 2026 report, a survey of 1,428 US talent professionals. That speed, however, did not make them any more confident they had found the right person. In fact, of the recruiters that claim AI has made them faster, a third reported no gain in confidence at all, and 18% say their confidence in the match actually fell. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019723138/en/ Recruiters report gains in speed from AI but not in certainty - TestGorilla’s Recruiting in the AI era 2026 report Recruiters are making up the difference themselves, by hand. Of those recruiters, 67% now spend an hour or more manually checking a single candidate before they trust that person can do the job, and nearly 30% spend two hours or more. That is time AI sourcing was supposed to save, not divert to new, extra work. "Recrui
Fortanix Announces Confidential AI for Enterprise Grade Kubernetes Workloads on CNCF® Confidential Containers (CoCo)19.10.2026 16:00:00 EEST | Press release
Fortanix® Inc., a global leader in data and AI security and pioneer of Confidential Computing, today announced support for CNCF Confidential Containers (CoCo) in Fortanix Confidential AI, enabling organizations to run AI workloads on Kubernetes inside hardware-based Trusted Execution Environments (TEEs), on confidential CPUs and GPUs. Enterprises keep the speed and agility of containers while protecting sensitive data, AI models, agents, and applications in use, so they can support their regulatory compliance efforts, scale AI across the business, and adopt frontier AI without compromising data privacy or intellectual property. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019549928/en/ Confidential AI is a critical need in the industry today and a strong ecosystem of industry leaders is collaborating to advance open innovation and help enterprises securely adopt AI at scale. Regulated industries, including financial ser
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