USA – Roche Diagnostics has received FDA approval for its new blood test that measures lipoprotein (a), or Lp(a), levels in the bloodstream using molar units instead of traditional mass units.
This test, called the Tina-quant Lipoprotein (a) Gen.2 Molarity assay, marks a significant step forward in assessing cardiovascular risk and managing lipid disorders.
High levels of Lp(a) are a genetic factor associated with cardiovascular disease (CVD). Elevated levels increase the likelihood of blood clots and aortic valve calcification, making it a critical biomarker for assessing heart health.
Experts anticipate that Lp(a) testing will soon become routine in screening and managing patients with suspected cardiovascular disease.
According to Roche, this new test, announced on January 29, 2025, can help clinicians better understand a patient’s risk of atherosclerotic cardiovascular disease (ASCVD) when combined with other lipoprotein tests and clinical assessments.
Speaking about the genetic nature of Lp(a), Dr. Pam Taub, a cardiovascular medicine professor at UC San Diego School of Medicine, stated, “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.”
The Roche Diagnostics assay is the first FDA-approved test to measure Lp(a) in nanomoles per liter (nmol/L), a unit that provides greater accuracy by accounting for variations in particle size.
Unlike other biomarkers, Lp(a) levels are unaffected by diet or exercise, as genetics determine over 90% of its concentration.
Brad Moore, CEO of Roche Diagnostics North America, explained, “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.”
The introduction of this test aligns with growing efforts to incorporate Lp(a) measurements into regular diagnostic evaluations.
Approximately 1 in 5 people have elevated Lp(a) levels, with higher prevalence observed in individuals of African descent and postmenopausal women.
By measuring Lp(a) in nmol/L, clinicians can more accurately assess cardiovascular risk and develop personalized prevention strategies for patients.
Roche’s new test is expected to be widely available in the U.S. on the company’s cobas® c analyzers, enabling routine blood tests to provide crucial insights into a patient’s cardiovascular health.
Additionally, in May 2024, the FDA granted Breakthrough Device Designation to the Roche Tina-quant Lp(a) RxDx assay, a tool designed to identify patients who may benefit from forthcoming Lp(a)-lowering therapies.