MA-NUMARES
24.3.2021 12:02:04 CET | 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/
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/
View source version on businesswire.com: https://www.businesswire.com/news/home/20210324005057/en/
About Business Wire
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
ILiAD Biotechnologies Announces $115M Oversubscribed Series B Financing to Advance BPZE1 Pertussis Vaccine10.2.2026 14:00:00 CET | Press release
Financing round led by RA Capital ManagementProceeds to support Phase 3 development of BPZE1 with pivotal study to begin in 2026 ILiAD Biotechnologies, Inc. (ILiAD), an advanced clinical stage biotech company focused on the prevention and treatment of disease caused by Bordetella pertussis, today announced the successful closing of an oversubscribed $115 million Series B financing. The financing was led by RA Capital Management with participation from new investors Janus Henderson Investors and BNP Paribas Asset Management Alts, as well as existing investors including a multi-national pharmaceutical company and AI Life Sciences. As part of the financing, Mario Barro, Ph.D., Head of Infectious Diseases at RA Capital Management has joined ILiAD’s Board of Directors. Proceeds from the Series B financing will support the advancement of ILiAD’s next generation pertussis vaccine candidate, BPZE1. Inducing both systemic and mucosal immunity, BPZE1 is a live attenuated intranasal pertussis vac
Armis Launches Armis Centrix™for Application Security to Secure the Code that Runs Organizations10.2.2026 14:00:00 CET | Press release
Solution helps security teams reduce cyber risk exposure, operate more efficiently and streamline their security stack Armis, the cyber exposure management & security company, today announced Armis CentrixTM for Application Security, which unifies application security across an organization’s software development lifecycle. The technology helps security teams secure code as a next-generation attack vector to fortify organizations’ defenses and protect against cyber threats. “To effectively manage risk, it’s essential to get to the root cause of the problem and weed it out,” said Nadir Izrael, CTO and Co-Founder of Armis. “Code-based vulnerabilities are being embedded into organizational infrastructure, and AI-generated code is exacerbating the problem, containing exponentially more vulnerabilities when compared to code written by human developers. As enterprises embrace AI-assisted coding and drive continuous development pipelines, they need a smarter, more dynamic, and unified approac
Sam Elbeck of ExaGrid Honored as a 2026 CRN® Channel Chief10.2.2026 14:00:00 CET | Press release
ExaGrid®, the industry’s only Tiered Backup Storage solution with AI-Powered Retention Time-Lock (RTL) that includes a non-network-facing tier (creating a tiered air gap), delayed deletes and immutability for ransomware recovery,today announced that CRN®—a brand of The Channel Company—has selected Sam Elbeck, ExaGrid’s Vice President of Americas Sales and Channel Partners, for inclusion on the prestigious 2026 CRN® Channel Chiefs list. This annual recognition celebrates IT vendor and distribution executives who are shaping channel strategy and driving innovation and partnership across the industry. “It’s an honor to be named to the Channel Chiefs list again this year,” said Sam Elbeck. “We are committed to the channel and view our partners as an extension of ExaGrid. We collaborate closely on every opportunity to ensure mutual success. Our channel philosophy centers on building long-term relationships grounded in honesty, integrity, and transparency. We strive for ExaGrid to be known a
Vasion Appoints Scott Lee as Chief Product Officer to Accelerate the Impact of Intelligent Print Automation10.2.2026 14:00:00 CET | Press release
Seasoned enterprise product leader brings proven track record of scaling product organizations and driving exponential value Vasion, a leader in serverless printing and Intelligent Print Automation, today announced the appointment of Scott Lee as Chief Product Officer. Lee brings more than 25 years of C-level product and growth leadership experience transforming and scaling enterprise SaaS companies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260210803525/en/ Scott Lee joins Vasion as Chief Product Officer, bringing more than 25 years of enterprise SaaS leadership experience to accelerate the company's intelligent print automation platform and AI-ready capabilities. As Chief Product Officer at Vasion, Lee will lead product management, product design, and product operations. He will focus on expanding strong product foundations and ensuring customer value as the company scales. His extensive experience modernizing complex
Kingswood Capital Management Enters Into a Definitive Agreement to Acquire Coveris’ Paper Unit, Rebrands as Paragon Print and Packaging10.2.2026 13:00:00 CET | Press release
Kingswood Capital Management, LP (together with its affiliates, “Kingswood”) announced today that it has entered into a definitive agreement to acquire Business Unit Paper (“BU Paper”) from Coveris, a global manufacturer of paper and plastic packaging solutions. As part of the transaction, BU Paper will be rebranded Paragon Print and Packaging (“Paragon”), restoring the unit’s original name. Jo Ormrod, Chief Operating Officer, will serve as Paragon’s Chief Executive Officer, and the existing company management will remain in place. The transaction is expected to close in several weeks, subject to customary legal and regulatory requirements. Paragon produces high-quality, sustainable paper-based packaging solutions, including for key end markets such as food, household, and personal care. The company, which was established in 1994, specializes in products like self-adhesive and linerless labels, lined board, cartons, and trays using eco-friendly materials. “We are excited about our next
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