FDA Clears Numares Health Cardiovascular Diagnostic Test and Core Technology Platform

01 August 2023 | Tuesday | News

- 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.

FDA-cleared AXINON® System

  • More than 3 million tests run using AXINON®
  • Innovative testing modality: Uses distinct, transparent algorithms to combine and quantify multiple biomarkers
  • Specific biomarker measurement: Key tool physicians can use to in managing lipoprotein disorders associated with cardiovascular diseases, including atherosclerosis
  • Automated: Runs hundreds of samples a day with just one hour of lab employee time

Heart disease in the US (source, US Centers for Disease Control and Prevention)

  • Incidence: Heart disease is the leading cause of death in the US
  • Mortality: One person dies every 33 seconds from cardiovascular disease. About 695,000 people in the US died from heart disease in 2021 — one in every five deaths
  • Health care costs: Heart disease cost about $239.9 billion per year (2018 to 2019). This includes the cost of health care services, medicines and lost productivity due to death.

*El Harchaoui, K., et al. Value of low-density lipoprotein particle number and size as predictors of coronary artery disease in apparently healthy men and women: The EPIC-Norfolk Prospective Population Study. J Am Coll Cardiol, 2007. 49(5): p. 547-53.

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