Roche Wins FDA Nod for Blood Test to Measure Lp(a) in Molar Units

Roche revealed that its Lipoprotein (a) Gen.2 Molarity assay has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance.

According to the company, this is the first 510(k)-cleared test of its kind in the U.S. to measure lipoprotein (a), or Lp(a), in nanomoles per liter (nmol/L). The National Lipid Association (NLA) recommends all adults measure their Lp(a) (often referred to as L-P-Little-A) at least once in a lifetime to help evaluate cardiovascular risk.

Because of its unique properties, Lp(a) can vary in size and has no single, defined molecular weight. For this reason, there’s 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), instead of mass units (mg/dL), and any conversion between mass and molar units is generally imprecise and unreliable.

By using molar units, laboratory professionals and clinicians know the Lp(a) measurements reflect the number of particles, rather than any difference in the particles’ size. Lp(a) is becoming an important, yet under-recognized, potential risk factor for cardiovascular disease because it can promote development of plaques in artery walls, clot formation, and aortic valve calcification.

“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, MD, FACC, FASPC, 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.”

“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.”

Last week, the company received FDA clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat sexually transmitted infection (STI) multiplex assay panels.