News | February 03, 2025

Roche's Lp(a) Gen.2 Molarity Assay Receives FDA Clearance

The Roche Diagnostics Tina-quant Lipoprotein (a) Gen.2 Molarity assay is an in-vitro test measuring lipoprotein (a) in a person’s bloodstream (serum and plasma), and will be broadly available on Roche's chemistry systems in the U.S. 


January 29, 2025 – Roche announced today that the Tina-quant Lipoprotein (a) Gen.2 Molarity assay has received 510(k) clearance from the United States Food and Drug Administration (FDA). This will be the first 510(k) cleared test of its kind available in the U.S. measuring 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 assess cardiovascular risk.

Due to its unique properties, Lp(a) can vary in size and has no single, defined molecular weight. For this reason, 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 mass units (mg/dL), and that 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 size of the particles. 

"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. 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, said Brad Moore, president and CEO at Roche Diagnostics North America.

Lp(a) is emerging as an important, yet under-recognized, potential risk factor for cardiovascular disease due to its ability to promote the development of plaques within artery walls, clot formation and aortic valve calcification. More than 90% of the Lp(a) level is influenced by variations in the genes controlling the Lp(a) particle production,2 in which lifestyle interventions such as diet and exercise have no significant impact. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease (ASCVD) risk when used in conjunction with clinical evaluation and other lipoprotein tests.3,4

"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. 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, said Pam  Taub, M.D., FACC, FASPC, professor at UC San Diego School of Medicine for the Department of Cardiovascular Medicine.

The development of the Tina-quant® Lipoprotein (a) Gen.2 Molarity assay aligns with Roche’s commitment to lead with science in order to develop transformational solutions that help improve patient outcomes and simplify lab operations. In addition to addressing traditional modifiable risk factors, healthcare professionals increasingly rely on biomarkers like Lp(a) and high sensitive-CRP to enhance cardiovascular risk stratification and provide more comprehensive assessments. Roche’s leadership in this field highlights its commitment to advancing innovation in preventive cardiology, emphasizing the importance of accurate Lp(a) testing in nmol/L to refine risk prediction and improve cardiovascular health management.

For more information, please visit www.roche.com.

 

  1. Tsimikas S and Marcovina S, Ancestry, Lipoprotein(a), and Cardiovascular Risk Thresholds: JACC Review Topic of the WeekJ Am Coll Cardiol. 2022 Aug, 80 (9) 934–946
  2. Kronenberg F. et al, Lipoprotein(a) in atherosclerotic cardiovascular disease and aortic stenosis: a European Atherosclerosis Society consensus statement, European Heart Journal, Volume 43, Issue 39, 14 October 2022, Pages 3925–3946
  3. Koschinsky ML et al. A focused update to the 2019 NLA scientific statement on use of lipoprotein(a) in clinical practice. J Clin Lipidol. 2024 May-Jun;18(3):e308-e319. doi: 10.1016/j.jacl.2024.03.001.
  4. Arnett DK et al. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e563-e595. doi: 10.1161/CIR.0000000000000677.

 


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