Heart disease is the leading cause of death in the US and costs healthcare systems nearly $240bn in total each year. Image credit: Shutterstock/Ahmet Misirligul.

The US Food and Drug Administration (FDA) has cleared a new test from Numares Health that measures the amount of lipoprotein by nuclear magnetic resonance (NMR) for patients at risk of cardiovascular disease. 

The Regensburg, Germany-based diagnostics company has developed a technology platform called AXINON – which was also cleared as part of the device – that incorporates algorithms into NMR spectroscopy. The device uses machine learning to identify specific metabolites relevant to diagnosis. The same platform is also used by the company for identifying biomarkers related to kidney and liver diseases.  

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Numares said that it expects a kidney assay function using the same technology to receive FDA clearance later this year.  

According to Numares, low-density lipoprotein particle (LDL-p) can provide more detailed information relating to cardiac function than low-density lipoprotein cholesterol (LDL-C) – the currently used biomarker. 

A market model by GlobalData forecasts that the cholesterol testing market will be worth over $4bn by 2033.  

There have been studies investigating the improved accuracy of LDL-p compared to LDL-C, the latter being culpable of overestimating coronary risk. Whilst LDL-C is still a good indicator, LDL-p could be particularly useful in patients with chronic conditions such as diabetes.  

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LDL-p is a bi-product of fat transport that remain in circulation. It can get stuck in the artery wall, forming fatty plaques. Over time, this can lead to artery blockage.  

Heart disease is the leading cause of death in the US and costs healthcare systems nearly $240bn in total each year.  

Numares received €20m ($22m) in funding at the end of 2022 from the European Investment Bank.

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