numares announces FDA 510(k) Submission of AXINON System ® , a NMR platform for metabolomics-based, AI-driven Diagnostics
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.
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/
Tel.: +49 941 280 949-14
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Loomis Sayles Welcomes Susan Sieker as Chief Financial Officer12.4.2021 16:15:00 CEST | Press release
Loomis, Sayles & Company, an affiliate of Natixis Investment Managers, announced today that Susan Sieker has joined Loomis Sayles as executive vice president and chief financial officer (CFO). She also joins the Loomis Sayles Board of Directors. Susan reports to Kevin Charleston, chairman and chief executive officer of Loomis Sayles, and will oversee the finance organization. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210412005613/en/ Susan joins Loomis Sayles from Cambridge Associates, where she was the chief financial officer and oversaw financial planning and analysis, treasury, accounting operations, financial reporting, payroll and taxes. Prior to joining Cambridge Associates in 2012, Susan served in a variety of finance and risk leadership roles at Brinker International, including vice president and treasurer, vice president of global infrastructure, vice president of benefits, vice president of business assurance
Alira Health Strengthens Its Growth Strategy With a $35M Funding, Led by Creadev12.4.2021 15:00:00 CEST | Press release
Alira Health (www.alirahealth.com), a leading international advisory firm dedicated to advancing healthcare and life sciences, announced it has closed a $35M equity financing led by Creadev, an evergreen investment company backed by the Mulliez family. This new partnership will help accelerate the firm’s growth strategy, focused on merging pharmaceutical, medical and digital technologies development with medical care through a patient-centric approach. “I would like to thank our team of investors for joining our mission to enable healthcare transformation. Their investment positions us to change the way life sciences advisory services are delivered,” said Gabriele Brambilla, Chief Executive Officer and Co-Founder of Alira Health. “We are building a powerful continuum of services that spans the product and solutions development life cycle, supported by the recent additions of our patient engagement, real-world evidence and advanced analytics practices. This financing allows us to advanc
KD Pharma Acquires Phytoextract and CBD Manufacturing Assets12.4.2021 14:45:00 CEST | Press release
The KD Pharma Group has acquired the manufacturing assets of a Swiss-based cannabinoid manufacturer. The assets give KD Pharma access to technology for producing Active Pharmaceutical Ingredients (APIs) based on phytocannabinoids and other plant extracts. The technology further expands KD’s lipid technology portfolio and can be used in combination with KD’s other fractionation and separation technologies. “KD Pharma is a leader in lipid technology focused primarily on omega-3s, but our technology suite has applications in other lipid sources like cannabinoids,” said Oscar Groet, CEO of the KD Pharma Group. “We have committed to expanding our technology portfolio to develop APIs from cannabinoids and plant extracts,” Groet continued, “and these assets give KD Pharma additional pathways to develop new products for this emerging market.” The KD Pharma Group has also licensed a novel extraction method from Herbolea Biotech S.r.l. and expects to have a complete, licensed cGMP manufacturing
Globality and BT Sourced Announce New Partnership to Unleash the Power of Procurement12.4.2021 14:00:00 CEST | Press release
Through a new partnership with Globality and BT’s new procurement company, BT Sourced, BT launched Globality’s AI-powered Smart Sourcing® Platform to transform how BT employees source and procure services. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210412005173/en/ “BT’s changing and so is procurement. Digitization is the driving force for long-term growth and value to the BT customer and operating model,” said Cyril Pourrat, Chief Procurement Officer, BT. “Partnering with Globality will help us to embrace digital technology and simplify our processes.” “Having immediate access to our current suppliers and Globality’s diverse global network will bring agility and new value to our teams,” added Pourrat. BT now uses Globality’s AI advisor, Glo™, to quickly and easily source the best suppliers for consulting, marketing, IT, HR, legal and other service categories. “BT is revolutionizing the way it sources services in order t
FLIR Wins DARPA Contract Worth Up to $20.5M to Develop Revolutionary New Protective Fabrics for Chem-Bio Defense12.4.2021 14:00:00 CEST | Press release
FLIR Systems, Inc. (NASDAQ: FLIR) announced it has won a contract with the Defense Advanced Research Projects Agency (DARPA) to rapidly develop novel fabrics with embedded catalysts and chemistries that can fight and reduce chemical and biological threats upon contact. The revolutionary fabrics will be incorporated into protective suits and other equipment such as boots, gloves, and eye protection that can be worn by troops on the battlefield, medical experts, healthcare workers, and more. FLIR received $11.2 million in initial funding for the potential five-year effort worth up to $20.5 million, including options. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210412005140/en/ The Personalized Protective Biosystems (PPB) program will create fabrics with built-in ability to fight chemical and biological agents, from VX to chlorine gas to Ebola virus. The revolutionary fabrics being developed by FLIR Systems will be incorpora
Mirum Pharmaceuticals and Vivet Therapeutics Enter into Exclusive Worldwide Option and License Agreement for Vivet’s Gene Therapy Programs Targeting Progressive Familial Intrahepatic Cholestasis12.4.2021 14:00:00 CEST | Press release
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) and Vivet Therapeutics (“Vivet”) announced today an agreement whereby Mirum has the exclusive option to develop and subsequently commercialize Vivet’s two proprietary AAV gene therapy programs for progressive familial intrahepatic cholestasis (PFIC), subtypes 3 and 2. The two programs, VTX-803 and VTX-802, are currently being evaluated in preclinical studies by Vivet, a privately-held gene therapy biotechnology company. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210412005354/en/ Under the terms of the agreement, Vivet will continue to advance the preclinical studies for VTX-803 and VTX-802 for PFIC3 and PFIC2, respectively. Mirum has the exclusive option to license the programs after which Mirum would lead the clinical development and any future commercialization of the programs. Until that time, Mirum will provide funding to support the continued research and development costs
Riffyn Launches Riffyn Nexus v4.2 to Strengthen Bioprocess Data Integrity With Automated Data Validation12.4.2021 13:50:00 CEST | Press release
Riffyn's pioneering cloud-based process data system for Intelligent Process Development has been upgraded with more powerful capabilities. The new features in Riffyn Nexus v4.2 enable customers to validate data real-time at a large scale with the ability to trace the root cause of an anomaly. Data integrity in process development is critical to rapid, high-quality drug and biotech product development. Inadequate data can mislead decisions and cost tens of million dollars in lost time, resources, and investment by sending an entire product development program down the wrong path. "Riffyn Nexus now gives the complete package of capabilities needed for process developers to ensure data integrity in their decision-making, while preserving their agility to innovate," said Riffyn CEO Timothy Gardner. "The new features in Riffyn Nexus automatically check all the collected data on each experiment in real-time — 3,300 samples, parameters, or measurements checked per second." Riffyn Nexus has al