numares Made 510(k) Submission to FDA for Its AXINON IVD System

numares Made 510(k) Submission to FDA for Its AXINON IVD System

Healthcare Tech Outlook | Wednesday, April 28, 2021

numares announces FDA Submission of AXINON System, an NMR platform for metabolomics-powered, AI-driven Diagnostics.

FREMONT, CA: Pioneering NMR diagnostics firm numares AG announced that the firm made a 510(k) submission to the U.S. Food and Drug Administration (FDA) for its AXINON IVD System, an NMR-platform for AI-based, metabolomics-powered diagnostics. If cleared, AXINON would become the first NMR-powered clinical laboratory system leveraging AI-evaluated metabolic data. Many multi-marker assays for AXINON will cover many unmet medical requirements to prevent, diagnose and treat disease.

The clearance of AXINON would bring a new diagnostic method to clinical laboratories, the combination of many metabolic biomarkers, so-called metabolite constellations, analyzed by innovative nuclear magnetic resonance (NMR) technology and evaluated by numares' proprietary, AI-based AXINON diagnostic software.

After entering into partnership 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 the common endeavor to bring NMR diagnostics into clinical use and make metabolomics-powered diagnostics accessible to the patients. numares is presently developing multi-marker algorithms for several diagnostic tests on the AXINON IVD System. These comprise AXINON GFRNMR to reliably assess kidney function by enhanced determination of glomerular filtration rate (GFR). numares hopes to submit this test to the FDA also in the first half of 2021.

AXINON offers clinical laboratories with a potential technology that uses the information-rich metabolome with artificial intelligence to provide healthcare professionals new insights into disease diagnosis and management for enhanced patient outcomes. Simultaneously, automation potentials, excellent precision, seamless operability will enable easy adaption of the FDA-cleared system by clinical laboratories. They will make AXINON an indispensable routine diagnostic tool in precision medicine.

Patients will benefit from the approach to consider the patient's metabolome with smart algorithms. Once cleared by the FDA, the firm believes AXINON can meaningfully enhance health outcomes and quality of life for millions of patients. The AXINON System consists of AI-powered AXINON Software, ready-to-use AXINON kits, and an innovative NMR technology, refined by numares' proprietary Magnetic Group SignalingTM to ensure highly standardized and automated processing of serum or urine samples in high-throughput.

Weekly Brief