Roche Diagnostics, part of Swiss pharmaceutical company Roche (SIX: RO, ROG) (OTCQX: RHHBY), announced on Wednesday that it has received 510(k) approval from the US Food and Drug Administration (FDA) for its Tina-quant Lipoprotein (a) Gen.2 Molarity assay.

This will be the first 510(k) cleared test of its kind available in the US to measure lipoprotein (a), or Lp(a), in nanomoles per litre (nmol/L). Around one in five people worldwide has elevated Lp(a) levels, putting them at increased risk of cardiovascular diseases including myocardial infarction and stroke.

Brad Moore, Roche Diagnostics' North America president and CEO, said: "We are proud to support the National Lipid Association's recommendation for Lp(a) testing, emphasising accurate cardiovascular risk assessment with the first FDA-cleared test measuring in nmol/L units in the US. Roche has an unrivalled ability to provide access to testing at scale and is committed to advancing innovation in preventive cardiology. 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."