Roche receives FDA Clearance for blood test that assesses cardiovascular risk

Roche announced that the Tina-quant® Lipoprotein (a) Gen.2 Molarity assay has received 510(k) clearance from the U.S. Food and Drug Administration. This marks the first FDA-cleared test of its kind available in the U.S. to measure lipoprotein (a), or Lp(a), in nanomoles per liter (nmol/L), a crucial step in assessing cardiovascular risk, according to the company.

The National Lipid Association recommends that all adults measure their Lp(a) at least once in a lifetime to help gauge their risk for cardiovascular disease. Unlike other lipid measurements, Lp(a) varies in size and lacks a single molecular weight. Because of this, experts agree that Lp(a) should be measured in particle concentration (nmol/L) rather than in mass units (mg/dL), as conversion between the two is unreliable. Using nmol/L ensures that laboratory professionals and clinicians obtain more precise readings that reflect the actual number of Lp(a) particles present in the blood.

"We are proud to support the National Lipid Association's recommendation for Lp(a) testing, emphasizing accurate cardiovascular risk assessment with the first FDA-cleared test measuring in nmol/L units in the U.S.," said Brad Moore, president and CEO of Roche Diagnostics North America, in a statement. "Roche has an unrivaled 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."

Lp(a) has gained attention as a significant but often under-recognized risk factor for cardiovascular disease due to its role in promoting plaque buildup in artery walls, clot formation, and aortic valve calcification. Unlike cholesterol and other lipids, Lp(a) levels are primarily determined by genetics and are not significantly affected by diet or exercise. Approximately 20% of individuals have elevated Lp(a) levels, which may increase their risk for atherosclerotic cardiovascular disease (ASCVD).

"Through no fault of our own, Lp(a) levels are determined at birth by genetics and thought to be unaffected by lifestyle changes, with approximately 20% of individuals living with elevated levels of this particle," said Pam Taub, M.D., professor at the UC San Diego School of Medicine for the Department of Cardiovascular Medicine. "With the opportunity to now consistently and accurately measure Lp(a) in particle concentration units, and anticipated Lp(a)-lowering treatments coming to market, clinicians have an opportunity to help their patients understand and potentially lower their cardiovascular risk."

The development of the Tina-quant Lipoprotein (a) Gen.2 Molarity assay aligns with Roche's mission to lead with science and create innovative solutions for improved patient outcomes, according to the company. As health care professionals continue to refine cardiovascular risk assessment, biomarkers like Lp(a) and high-sensitivity CRP are playing an increasingly vital role in guiding preventive strategies.