NEW YORK – Roche said Wednesday that its Tina-quant Lipoprotein (a) Gen.2 Molarity assay has received 510(k) clearance from the US Food and Drug Administration.
The test, which is intended for assessing cardiovascular risk, is the first lipoprotein (a), or Lp(a), test measured in nanomoles per liter to receive FDA clearance.
Lp(a) can promote the development of arterial plaques, clot formation, and aortic valve calcification and is a potential risk factor for cardiovascular disease. Roughly 20 percent of individuals have elevated Lp(a) levels, which are largely due to variations in the LPA gene. The National Lipid Association recommends that adults measure their Lp(a) level at least once in a lifetime.
According to Roche, Lp(a) particles can vary in size and have no single, defined molecular weight, making a measurement in molar units potentially more informative than measurements made in mass units.
While Lp(a) levels are not impacted by lifestyle interventions like diet changes and exercise, Lp(a) lowering drugs are in development.
"Roche has an unrivaled ability to provide access to testing at scale and is committed to advancing innovation in preventive cardiology," Brad Moore, president and CEO of Roche Diagnostics North America, said in a statement. "This clearance comes in advance of disease-modifying therapies on the horizon expected to help clinicians use this biomarker to guide patients to improved cardiovascular health."