Sam Brusco, Associate Editor08.01.23
The U.S. Food and Drug Administration (FDA) has cleared the Numares Health test, the AXINON LDL-p test system, for physicians to measure lipoproteins for patients at risk of cardiovascular disease.
The clearance also covers the company’s core AXINON system tech platform, which uses diagnostic testing algorithms in nuclear magnetic resonance (NMR) spectroscopy. Numares uses this tech to develop diagnostic tests for chronic heart, kidney, and liver diseases. The company said a second Numares assay—the AXINON GFR(NMR) kidney function assay—is slated for FDA 510(k) clearance later this year.
From one blood sample, Numares quantifies multiple biomarkers, both known and newly discovered. The company then leverages machine learning to identify the few, specific metabolites relevant to diagnosis. Numares said The newly cleared test system offers more detailed information about cardiac function than the standard LDL-C (low-density lipoprotein or "bad cholesterol") measurement.
In a joint statement by the American College of Cardiologists and American Diabetes Association, LDL-p measurements, like those measured by the Numares AXINON LDL-p Test System, can help manage patients with elevated risk of cardiovascular disease, because these measurements may better reflect the true cardiac risk associated with cardiometabolic risk.
The clearance also covers the company’s core AXINON system tech platform, which uses diagnostic testing algorithms in nuclear magnetic resonance (NMR) spectroscopy. Numares uses this tech to develop diagnostic tests for chronic heart, kidney, and liver diseases. The company said a second Numares assay—the AXINON GFR(NMR) kidney function assay—is slated for FDA 510(k) clearance later this year.
From one blood sample, Numares quantifies multiple biomarkers, both known and newly discovered. The company then leverages machine learning to identify the few, specific metabolites relevant to diagnosis. Numares said The newly cleared test system offers more detailed information about cardiac function than the standard LDL-C (low-density lipoprotein or "bad cholesterol") measurement.
In a joint statement by the American College of Cardiologists and American Diabetes Association, LDL-p measurements, like those measured by the Numares AXINON LDL-p Test System, can help manage patients with elevated risk of cardiovascular disease, because these measurements may better reflect the true cardiac risk associated with cardiometabolic risk.