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
Grid Dynamics Launches Business Process Consulting Practice to Bridge the Gap Between AI Investment and Business Results27.10.2026 22:05:00 EET | Press release
Grid Dynamics Holdings, Inc. (Nasdaq: GDYN) (“Grid Dynamics”), a premier AI transformation partner for the Fortune 1000, today announced the launch of its Business Process Consulting practice, extending the company's AI transformation capabilities across the entire AI adoption lifecycle, beyond technology implementation to non-technical areas of enterprise AI value creation. Grid Dynamics has established itself as a leader in enterprise AI engineering, developing and deploying advanced AI solutions for some of the world's largest enterprises. Drawing on this experience, the company is expanding its focus to two critical factors in maximizing the business impact of AI: identifying the business domains and processes with the greatest potential for AI-driven improvement, and ensuring that the resulting solutions are successfully adopted across the enterprise. Starting with early discovery, the practice identifies and prioritizes high-value transformation opportunities, establishes busines
Logitech Announces Q2 Fiscal Year 2027 Results27.10.2026 22:05:00 EET | Press release
SIX Swiss Exchange Ad hoc announcement pursuant to Art. 53 LR — Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the second quarter of Fiscal Year 2027. Sales were $1.22 billion, up 3 percent in US dollars and 2 percent in constant currency, compared to Q2 of the prior year. GAAP gross margin was 44.9 percent, up 150 basis points compared to Q2 of the prior year. Non-GAAP gross margin was 45.2 percent, up 140 basis points compared to Q2 of the prior year. GAAP operating income was $201 million, up 5 percent compared to Q2 of the prior year. Non-GAAP operating income was $231 million, up 0.4 percent compared to Q2 of the prior year. GAAP earnings per share (EPS) was $1.25, up 9 percent compared to Q2 of the prior year. Non-GAAP EPS was $1.51, up 4 percent compared to Q2 of the prior year. Cash flow from operations was $164 million. The quarter-ending cash balance was $1.51 billion. The Company returned $406 million of cash to shareholders in the qu
Hightouch Partners with Independent Media to Activate Reader and Commercial Data27.10.2026 18:01:00 EET | Press release
Hightouch, the leading agentic marketing platform, today announced a partnership with Independent Media, publisher of The Independent. Independent Media will use Hightouch to connect its customer data to marketing tools. With Hightouch, the company will send readers more relevant membership and subscription offers, build stronger audiences for its advertising partners, and grow its affiliate and e-commerce business. “Deepening customer relationships and delivering real value to our commercial partners requires moving seamlessly from insight to action,” said Krishan Gandhi, Director of Data Intelligence and Monetisation at Independent Media. “Partnering with Hightouch allows us to utilise our warehouse data directly into our engagement tools, powering real-time, omnichannel journey orchestration, while enabling us to build premium audience segments with far greater speed and agility.” “Independent Media has a large, loyal readership and strong relationships with advertisers,” said Matth
IFF Identifies Ten Consumer Moments Reshaping Food and Beverage Innovation in the GLP-1 Era27.10.2026 17:00:00 EET | Press release
IFF (NYSE: IFF)—a global leader in flavors, fragrances and health and biosciences, today launched its latest report, “GLP-1 Consumer Moments of Opportunity.” The report uncovers ten emerging consumer moments that reflect the changing needs of consumers using GLP-1 medications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261026614988/en/ New report from IFF uncovers ten emerging consumer moments that reflect the changing needs of consumers using GLP-1 medications. “What GLP-1 users need from food and beverage products depends on the moment, and those needs can change many times throughout the day,” said Yuvraj Arora, president of IFF Taste. “The most successful innovations will be designed around the occasions that matter most to consumers, delivering the right balance of nutrition, enjoyment and functionality for each one. Understanding these moments can unlock entirely new avenues for innovation." While much of the indus
Phison Receives Micron Global Supplier Awards27.10.2026 16:00:00 EET | Press release
Phison Electronics (8299TT), a global leader in NAND flash controllers and storage solutions, is honored to announce that it was presented with Outstanding Supplier Performance Awards in the Semiconductor category and the Best in Quality – Assembly and Test categoryat the Micron Supplier Day 2026. The event, held in Boise, Idaho, United States was attended by top-level management of Micron and its suppliers, including Phison. The awards highlight our commitment to excellence in quality, innovation and collaboration with Micron, a global leader in semiconductor memory and storage. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261027158504/en/ Phison wins Outstanding Supplier Performance Award in Semiconductor category and the Best in Quality – Assembly and Test category at the Micron Supplier Day 2026 “Receiving our third Micron Supplier Award in a row is a tremendous honor and a testament to the strength of our partnership
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