NEW YORK – The US Food and Drug Administration has granted 510(k) clearance to Numares Health's Axinon LDL-p test for measuring lipoproteins and identifying patients at risk for cardiovascular disease, the medtech firm said Tuesday.
Numares, which has offices in Boston and Regensburg, Germany, developed the Axinon LDL-p test system as a diagnostic that physicians can use to measure the concentration of low-density lipoprotein particles (LDL-p) in a patient's blood, high levels of which have been associated with risk of developing cardiovascular disease.
The regulatory clearance also comprises the firm's technology platform, the AXINON System, which incorporates diagnostic algorithms that quantify biomarkers and nuclear magnetic resonance spectroscopy. FDA clearance of the platform as part of the LDL-p test system will provide a pathway for Numares to garner clearance of other tests it is developing for metabolic conditions, the firm said.
Numares is expecting to receive FDA clearance for another assay, the Axinon GFR (NMR) test for gauging kidney function, later this year.