Blood Test Measures Lipoprotein (a) in Molar Units for Better Cardiovascular Risk Assessment

Around one in five people worldwide have elevated levels of lipoprotein (a), or Lp(a), which increases their risk for cardiovascular diseases such as myocardial infarction and stroke. It is advised that adults have their Lp(a) measured at least once in their lifetime to help assess cardiovascular risks. Due to its unique structure, Lp(a) can vary in size and lacks a single defined molecular weight. As a result, there is a consensus in the scientific community that Lp(a) levels should be measured in terms of the number of particles per liter of blood (nmol/L) rather than in mass units (mg/dL), as any conversion between mass and molar units tends to be inaccurate and unreliable. Using molar units allows laboratory professionals and clinicians to understand that Lp(a) measurements reflect the number of particles, not differences in particle size. Now, the first U.S. Food and Drug Administration (FDA)-cleared test for measuring Lp(a) in a person’s blood in nmol/L units is available, helping mitigate the influence of particle size variations on the measurement.

Roche’s (Basel, Switzerland) Tina-quant Lipoprotein (a) Gen.2 Molarity assay has received the first 510(k) clearance for measuring Lp(a) in nmol/L, marking a significant milestone. Lp(a) is becoming increasingly recognized as an important risk factor for cardiovascular disease because it promotes plaque buildup in artery walls, clot formation, and aortic valve calcification. Over 90% of Lp(a) levels are influenced by genetic factors controlling Lp(a) particle production, meaning lifestyle changes such as diet and exercise have little impact. Measuring Lp(a) is useful in evaluating lipid metabolism disorders and assessing the risk of atherosclerotic cardiovascular disease (ASCVD) when combined with other clinical evaluations and lipoprotein tests. The FDA has granted 510(k) clearance to the Tina-quant Lipoprotein (a) Gen.2 Molarity assay, reinforcing its importance in assessing cardiovascular disease risks.

The Lp(a) test is conducted via a routine blood draw, where a small sample is used to measure the number of Lp(a) particles per liter of blood (serum and plasma). This helps clinicians take actionable steps to reduce future risks of atherosclerotic cardiovascular disease. The test will be widely available on cobas c analyzers. The Tina-quant Lipoprotein (a) Gen.2 Molarity assay is part of Roche's commitment to leading scientific advancements in healthcare, aiming to improve patient outcomes and simplify laboratory processes. In addition to traditional modifiable risk factors, healthcare professionals increasingly rely on biomarkers like Lp(a) and high-sensitive C-reactive protein (hs-CRP) for better cardiovascular risk stratification and more comprehensive assessments. Roche’s leadership in this field underscores its dedication to advancing innovation in preventive cardiology and enhancing cardiovascular health management by providing accurate Lp(a) testing in nmol/L to improve risk prediction.

"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. "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."

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