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
Klarna Card reaches 5 million active customers19.3.2026 15:31:00 CET | Press release
Klarna, the global digital bank and payments provider, today announced that the Klarna Card has reached 5 million active customers globally, underscoring rapid adoption as consumers shift towards new forms of payment which provide more control over day-to-day money management. The card draws from the customer's own funds for everyday spending, with the option to spread the cost of a specific purchase, like a large appliance or a flight, when it makes sense to do so. The result is a card that offers genuine spending control without the long-term debt obligations that come with traditional credit cards. The card’s growth is reinforced by Klarna’s membership program. The program offers premium perks such as airport lounge access, travel insurance, and lifestyle subscriptions — without requiring users to take on debt, meet spending thresholds, or revolve balances. By separating everyday spending from rewards, Klarna is challenging the strings-attached model legacy banks have long relied on
Stonebranch Releases 2026 Global State of IT Automation Report, Revealing Orchestration as the Missing Link for AI Adoption and Trust19.3.2026 14:30:00 CET | Press release
New research shows hybrid IT orchestration, automation-as-a-service, and WLA investments are accelerating as AI workflow deployment scales across the enterprise. Stonebranch, a leading provider of service orchestration and automation solutions, today released its annual 2026 Global State of IT Automation Report, the company’s most comprehensive research study to date. Based on responses from 402 IT automation professionals spanning C-suite executives to individual contributors across North America, EMEA, Latin America, and APAC, the report provides a detailed, data-driven portrait of how enterprises are investing in, deploying, and deriving value from IT automation in 2026. “This year’s findings highlight an important shift in how organizations approach automation,” said Giuseppe Damiani, CEO of Stonebranch. “Organizations are now building automation as strategic infrastructure — a governed, scalable foundation that spans hybrid environments, operationalizes AI, and delivers automation
Perma-Pipe Accelerates Growth with New U.S. Northeast Facility Investment to serve Artificial Intelligence Data Center customers, Provides Middle East Operations’ Update and Concludes the Board’s Review of Strategic Alternatives19.3.2026 14:00:00 CET | Press release
Perma-Pipe International Holdings, Inc. (the “Company”) today announced a strategic expansion initiative focused on accelerating growth through entry into the high-demand U.S. Northeast region. The Company is positioning itself to capitalize on the rapidly expanding Artificial Intelligence (“AI”)-driven data center market in both the United States and international markets while continuing to reinforce its leadership in critical infrastructure solutions. As part of this growth strategy, Perma-Pipe will prioritize investments aimed at expanding its presence in the rapidly evolving AI data center sector. The initiative reflects the Company’s long-term commitment to supporting next-generation technology infrastructure and strengthening its position in the global energy, industrial, and infrastructure markets. Expansion in the U.S. Northeast President & Chief Executive Officer, Saleh Sagr said, “We are excited to announce the expansion of our operations with a new facility in the Northeast
Armis Launches First-of-Its-Kind Benchmark Report Warning of Critical Security Gaps in AI-Native Development19.3.2026 13:00:00 CET | Press release
Research reveals 100% of leading generative AI models fail to generate secure code for critical development scenarios Armis, the cyber exposure management & security company, is warning that the rapid enterprise adoption of AI-native development is outpacing critical security safeguards, leaving organizations exposed to systemic vulnerabilities. New research from Armis Labs’ Trusted Vibing Benchmark Report, which evaluates 18 leading generative AI models across 31 test scenarios, reveals a 100% failure rate in generating secure code. These vulnerabilities are most prevalent in high-risk areas like memory buffer overflows, design file uploads and authentication systems. Therefore, organizations should immediately implement AI-native application security controls to reduce risk. “The era of vibe coding is here, but speed should not come at the cost of security,” said Nadir Izrael, CTO and Co-Founder of Armis. “Our research finds that the worst offenders are the same ones selling security
Morocco’s FRMF Welcomes CAF Appeal Board as Upholding Rules, Stability of International Competitions19.3.2026 12:53:00 CET | Press release
Following the announcement by the CAF Appeal Board, the Royal Moroccan Football Federation (FRMF) welcomes the decision, which reaffirms the primacy of competition regulations and reinforces the conditions necessary for the proper conduct of international tournaments. From the outset, following the incidents that led to the interruption of the match, the FRMF maintained a clear and consistent position: the strict application of the governing regulations. The Federation’s approach was solely guided by this principle. Following its appeal, CAF has now confirmed that the applicable regulations were not properly enforced. Throughout the process, the FRMF acted in full compliance with all relevant legal and procedural frameworks, with a constant focus on upholding its rights and preserving the integrity of the competition. This decision provides clarity on the applicable framework and strengthens the consistency and credibility of international competitions, particularly within African foot
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