Numares Health's Cardiovascular Diagnostic Test and Core Technology Platform Receive FDA Clearance
Wednesday, July 26, 2023
Numares Health has received FDA clearance for its AXINON® LDL-p Test System, providing physicians with a new tool to measure lipoproteins in patients at risk for cardiovascular disease. Notably, Numares is currently the sole US company selling an FDA-cleared NMR test. The FDA's clearance also covers Numares' proprietary AXINON® System, incorporating diagnostic testing algorithms using nuclear magnetic resonance (NMR) spectroscopy. This technology is utilized by Numares to develop diagnostic tests for chronic heart, kidney, and liver diseases. The approval of AXINON® technology paves the way for expedited FDA clearance of other tests currently in the pipeline. The company anticipates that its AXINON® GFR(NMR) kidney function assay will also receive FDA 510(k) clearance later this year.
Numares Health focuses on improving diagnostic testing for metabolic dysfunction-related conditions, such as chronic kidney, liver, and cardiac diseases. Their AXINON® LDL-p Test System offers more detailed cardiac function information compared to standard LDL-C (low-density lipoprotein or "bad cholesterol") measurement. Medical experts from the American College of Cardiologists and the American Diabetes Association have recognized the value of LDL-p measurements, similar to those provided by Numares' AXINON® LDL-p Test System, in managing patients with elevated cardiovascular disease risk. These measurements may better reflect the true cardiac risk, particularly in patients with cardiometabolic risk factors, as highlighted in a study by El Harchaoui et al*.
According to a consensus report, standard cholesterol measurement may not fully capture the actual cardiac risk, especially in patients with cardiometabolic risk factors, such as prediabetes, abdominal obesity, high lipid levels, and elevated triglycerides. The AXINON® technology has been used in over 3 million tests, making it a reliable and innovative testing modality. It utilizes transparent algorithms to combine and quantify multiple biomarkers, allowing for specific biomarker measurements that aid physicians in managing lipoprotein disorders associated with cardiovascular diseases, including atherosclerosis. Additionally, the AXINON® System is automated, capable of running hundreds of samples daily with minimal lab employee involvement.