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.
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
References
1. Tsimikas S and Marcovina S, Ancestry, Lipoprotein(a), and Cardiovascular Risk Thresholds: JACC Review Topic of the Week, J 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.
