German medical technology company Numares Health has received the US Food and Drug Administration (FDA) approval for its AXINON LDL-p test system.
The test system provides more detailed information about cardiac function than the standard low-density lipoprotein (LDL-C) or bad cholesterol measurement.
The FDA approval also includes the company’s core technology platform, the AXINON System.
AXINON system incorporates diagnostic testing algorithms into nuclear magnetic resonance (NMR) spectroscopy.
The company uses the technology to develop diagnostic tests for chronic heart, kidney and liver diseases.
Numares AXINON LDL-p test system is said to provide a new tool for physicians to measure lipoproteins for patients at risk for cardiovascular disease.
Also, it is the only company to sell an FDA-approved NMR test in the US, said Numares.
Numares, in its statement, said: “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.”
According to the American College of Cardiologists and the American Diabetes Association, LDL-p measurements may help physicians better manage patients with high risk of cardiovascular disease.
Also, the LDL-p measurements better reflect the true cardiac risk related to cardiometabolic risk.
Previous research showed that the LDL-p measurement is strongly associated with the future event of coronary artery disease, compared to LDL-C.
Also, the standard cholesterol measurement may not accurately reflect actual cardiac risk, especially in patients with cardiometabolic risk.
People with cardiometabolic risk include those with prediabetes, abdominal obesity, abnormally high lipid levels and elevated triglycerides.
Numares Health leverages AI technology to develop novel diagnostics for conditions stemming from metabolic dysfunction, including chronic kidney, cardiovascular and liver diseases.
The company develops advanced tests for diagnosis and measurement of disease progression by applying machine learning to metabolomics, along with multiple biomarkers.
