THE WOODLANDS, Texas and REGENSBURG, Germany, July 25, 2023 /PRNewswire/ -- The US Food and Drug Administration (FDA) has cleared a test from Numares Health, the AXINON® LDL-p Test System, as a new tool that clinicians can use to measure lipoproteins in patients with cardiovascular risk. Currently, Numares is the only company in the US that sells an FDA-cleared NMR test.
The FDA clearance also includes the company's core technology platform, the patented AXINON® system, which incorporates diagnostic testing algorithms into nuclear magnetic resonance (NMR) spectroscopy. Numares uses this technology to develop diagnostic tests for chronic diseases of the heart, kidneys and liver. This FDA clearance for the AXINON® technology provides a pathway for faster FDA clearance of other tests currently in development.
A second Numares trial is expected to obtain FDA 510(k) clearance later this year, the AXINON® GFR(NMR) Renal Function Trial.
Numares is a healthcare diagnostics company that develops enhanced diagnostic tests for conditions related to metabolic dysfunctions, such as chronic kidney, liver and heart diseases. From a single blood sample, Numares quantifies multiple biomarkers, known and newly discovered. Machine learning then identifies the specific metabolites relevant to the diagnosis.
The new AXINON® LDL-p Test System provides more detailed information on cardiac function than the standard measurement of LDL-C (low-density lipoprotein or "bad cholesterol").
In a joint statement from the American College of Cardiologists and the American Diabetes Association, LDL-p measurements, such as those measured by the Numares AXINON® LDL-p Test System, may assist physicians in the treatment of patients at elevated risk for cardiovascular disease, as these measurements may better reflect the true cardiac risk associated with cardiometabolic risk. El Harchaoui, et al* reported a greater association between LDL-p and future episodes of coronary disease compared with LDL-C.
The consensus report stated that standard cholesterol measurement may not accurately reflect true cardiac risk, especially in patients at cardiometabolic risk. Patients at cardiometabolic risk include those with prediabetes, abdominal obesity, abnormally high lipid levels, and elevated triglycerides.
AXINON®System authorized by the FDA
Cardiovascular disease in the US (source, US Centers for Disease Control and Prevention)
*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.
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About Numares HealthNumares Health is a healthcare company that uses AI-based technology to develop new diagnostics for conditions resulting from metabolic dysfunctions, including chronic kidney, cardiovascular and liver diseases. Numares develops advanced tests for the diagnosis and measurement of disease progression by applying machine learning to metabolomics, evaluating multiple biomarkers alone and in combination. The company has developed the FDA-cleared AXINON® system, which makes next-generation use of nuclear magnetic resonance spectroscopy for this biomarker assessment.
Contact: Alison Ruffin, Numares Health, alison.ruffin@numares.com o 770.310.6313
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