Numares Health's Cardiovascular Diagnostic Test and Core Technology Platform Receives FDA Clearance
Tuesday, August 01, 2023
Numares Health has obtained clearance from the US Food and Drug Administration (FDA) for its AXINON® LDL-p Test System, a new diagnostic tool for measuring lipoproteins in individuals at risk for cardiovascular disease. This approval makes Numares the exclusive provider of an FDA-approved NMR test in the United States. The clearance also includes the company's core technology platform, the AXINON® system, which combines diagnostic testing algorithms with nuclear magnetic resonance (NMR) spectroscopy to develop tests for chronic heart, kidney, and liver diseases. With FDA clearance for the AXINON® technology, other tests currently in development may also receive faster approval.
Numares Health specializes in healthcare diagnostics, focusing on advanced tests for diseases related to metabolic dysfunction, such as chronic kidney, liver, and heart conditions. Using a single blood sample, Numares quantifies multiple known and newly discovered biomarkers, with machine learning identifying specific metabolites relevant to accurate diagnosis.
The recently approved AXINON® LDL-p Test System provides more comprehensive information about heart function compared to the standard measurement of LDL-C (low-density lipoprotein or "bad cholesterol"). This is particularly beneficial for patients at cardiometabolic risk, including those with prediabetes, abdominal obesity, high lipid levels, and elevated triglycerides.
The innovative AXINON® LDL-p Test System employs transparent algorithms to combine and quantify multiple biomarkers, serving as a crucial tool for clinicians in managing lipoprotein disorders associated with cardiovascular disease, such as atherosclerosis. Additionally, it operates in an automated manner, processing hundreds of samples daily with minimal laboratory employee involvement. As of now, more than three million tests have been conducted using the AXINON® technology.