The FDA-cleared AXINON® LDL-p Test System, is 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.
A second Numares assay is expected to gain FDA 510(k) clearance later this year, the AXINON® GFR(NMR) kidney function assay.
The AXINON® HCC(NMR), a liver assessment and cancer early detection test, is in development.
AXINON® LDL-p Test System: Now FDA-cleared, provides more detailed information about cardiac function than the standard LDL-C (low-density lipoprotein or “bad cholesterol”) measurement.
AXINON® lipoFIT®: For cardiovascular risk assessment. CE-marked in the EU. For research use only in the US.
AXINON® GFR(NMR): New kidney function assay that combines two novel biomarkers, valine and myo-inositol, with creatinine and cystatin C using highly accurate nuclear magnetic resonance (NMR) spectroscopy. FDA 510(k) pending and available as CE-labeled IVD in the EU.
AXINON® HCC(NMR): Liver risk assessment and cancer early detection test. In development.