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 Health AXINON® System -- Now FDA-Cleared. (Credit: PR Newswire/ Numares Health)
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.
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.
Numares is a health care diagnostics company that develops improved diagnostic testing for conditions related to metabolic dysfunction, such as chronic kidney, liver and cardiac diseases. From a single blood sample, Numares quantifies multiple biomarkers — known and newly discovered. Machine learning then identifies the few, specific metabolites relevant to diagnosis.
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.
In a joint statement by the American College of Cardiologists and the American Diabetes Association, LDL-p measurements, like those measured by the Numares AXINON LDL-p Test System, can help physicians in managing patients with elevated risk of cardiovascular disease, because these measurements may better reflect the true cardiac risk associated with cardiometabolic risk. El Harchaoui, et al reported stronger association of LDL-p and future event of coronary artery disease compared to LDL-C.
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.
Source: Company Press Release