FDA clears first blood test of its kind for Lp(a)
The U.S. Food and Drug Administration (FDA) has cleared a new blood test from Roche Diagnostics designed to measure the amount of lipoprotein (a), or Lp(a), in a person’s blood stream using molar units instead of mass units.
Elevated Lp(a) levels is known to be a potential risk factor for cardiovascular disease (CVD), particularly due to its ability to cause blood clots to form and increase the risk of aortic valve calcification. As time goes on, Lp(a) testing is expected to become more and more common when screening and managing patients with suspected CVD.
The Roche Diagnostics Tina-quant Lipoprotein (a) Gen.2 molarity assay is the first FDA-cleared blood test to measure Lp(a) in nanomoles per liter (nmol/L) as opposed to milligrams per deciliter. This is intended to ensure all measurements are accurate and not influenced by differences in particle size.
“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.,” Brad Moore, president and CEO of Roche Diagnostics North America, said 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.”
“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,” added Pam Taub, MD, a cardiologist with UC San Diego School of 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.”
Click here for an in-depth look at the importance of Lp(a) levels from Cleveland Clinic.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.