THE WOODLANDS, Texas and REGENSBURG, Germany, July 25, 2023 /PRNewswire/ -- The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. Currently, Numares is the only company in the US selling an FDA-cleared NMR test. Numares Health AXINON® System — Now FDA-Cleared
The FDA clearance also includes the company's core technology platform, the proprietary AXINON® System, that incorporates diagnostic testing algorithms into nuclear magnetic resonance (NMR) spectroscopy. Numares uses this technology to develop diagnostic tests for chronic heart, kidney and liver diseases. This FDA clearance of the AXINON® technology provides a pathway for more rapid FDA clearance of other tests currently in development. A second Numares assay is expected to gain FDA 510(k) clearance later this year, the AXINON® GFR(NMR) kidney function assay.
The newly cleared AXINON® LDL-p Test System provides more detailed information about cardiac function than the standard LDL-C (low-density lipoprotein or "bad cholesterol") measurement.
The consensus report stated that standard cholesterol measurement may not accurately reflect actual cardiac risk, especially in patients with cardiometabolic risk. Patients with cardiometabolic risk include those with prediabetes, abdominal obesity, abnormally high lipid levels and elevated triglycerides. FDA-cleared AXINON® System
More than 3 million tests run using AXINON®
Innovative testing modality: Uses distinct, transparent algorithms to combine and quantify multiple biomarkers
Automated: Runs hundreds of samples a day with just one hour of lab employee time
Heart disease in the US (source, US Centers for Disease Control and Prevention) Health care costs: Heart disease cost about $239.9 billion per year (2018 to 2019). This includes the cost of health care services, medicines and lost productivity due to death. *El Harchaoui, K., et al. Value of low-density lipoprotein particle number and size as predictors of coronary artery disease in apparently healthy men and women: The EPIC-Norfolk Prospective Population Study. J Am Coll Cardiol, 2007. 49(5): p. 547-53. #precisiondiagnostics #diagnostictesting #biomarkers #NMRmetabolomics #innovation #cardiovascular #CAD #heartdisease #FDAclearance #FDA #CKD #kidneyfunction #HCC #liverdisease Numares Health is a health care company using AI-enabled technology to develop novel diagnostics for conditions stemming from metabolic dysfunction, including chronic kidney, cardiovascular and liver diseases. Numares develops advanced tests for diagnosis and measurement of disease progression by applying machine learning to metabolomics, evaluating multiple biomarkers alone and in combination. The company developed the FDA-cleared AXINON® System that makes next-generation use of nuclear magnetic resonance spectroscopy for this biomarker evaluation. Contact: Alison Ruffin, Numares Health, [email protected] or 770.310.6313