We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us

ROCHE DIAGNOSTICS CORP

Roche Diagnostics Corporation is the North American headquarters of Roche Diagnostics, a global leader in diagnostics... read more Featured Products: More products

Download Mobile App




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

By LabMedica International staff writers
Posted on 30 Jan 2025

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. More...

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."


Gold Member
Antipsychotic TDM Assays
Saladax Antipsychotic Assays
Portable Electronic Pipette
Mini 96
Urine Chemistry Control
Dropper Urine Chemistry Control
Human Estradiol Assay
Human Estradiol CLIA Kit
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Hematology

view channel
Image: New evidence shows viscoelastic testing can improve assessment of blood clotting during postpartum hemorrhage (Photo courtesy of 123RF)

Viscoelastic Testing Could Improve Treatment of Maternal Hemorrhage

Postpartum hemorrhage, severe bleeding after childbirth, remains one of the leading causes of maternal mortality worldwide, yet many of these deaths are preventable. Standard care can be hindered by delays... Read more

Immunology

view channel
Image: The CloneSeq-SV approach can allow researchers to study how cells within high-grade serous ovarian cancer change over time (Photo courtesy of MSK)

Blood Test Tracks Treatment Resistance in High-Grade Serous Ovarian Cancer

High-grade serous ovarian cancer (HGSOC) is often diagnosed at an advanced stage because it spreads microscopically throughout the abdomen, and although initial surgery and chemotherapy can work, most... Read more

Industry

view channel
Image: The collaboration aims to improve access to Hb variant testing with the Gazelle POC diagnostic platform (Photo courtesy of Hemex Health)

Terumo BCT and Hemex Health Collaborate to Improve Access to Testing for Hemoglobin Disorders

Millions of people worldwide living with sickle cell disease and other hemoglobin disorders experience delayed diagnosis and limited access to effective care, particularly in regions where testing is scarce.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.