FDA Approves Roche's First-of-its-Kind Tina-quant® Lipoprotein (a) Gen.2 for measuring Lp(a) in molar units

Roche has announced that its Tina-quant® Lipoprotein (a) Gen.2 Molarity assay has received 510(k) clearance from the United States Food and Drug Administration (FDA).

This test, designed to measure lipoprotein (a) [Lp(a)] levels in the bloodstream, is the first of its kind in the U.S. to provide measurements in nanomoles per litre (nmol/L).

Lp(a) is a recognised but often overlooked factor that increases the risk of cardiovascular diseases, including heart attacks and strokes.

Approximately one in five people worldwide has elevated Lp(a) levels, which are primarily determined by genetic factors and remain largely unaffected by lifestyle changes such as diet or exercise.

The test is performed using a routine blood draw and is intended for use with Roche's chemistry analysers, making it widely accessible in laboratories.

It is particularly useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease (ASCVD) risk when used alongside clinical evaluation and other lipid tests.

The clearance of the Tina-quant® Lipoprotein (a) Gen.2 Molarity assay supports Roche’s commitment to improving cardiovascular risk prediction and enhancing laboratory efficiency.

The ability to accurately measure Lp(a) particle concentration will help healthcare professionals make more informed decisions in identifying high-risk patients.

Additionally, Roche is advancing Lp(a)-related diagnostics through its Tina-quant® Lp(a) RxDx assay, which received a Breakthrough Device Designation from the FDA in May 2024.

This separate test is designed to assist in identifying patients who may benefit from emerging Lp(a)-lowering therapies.

The introduction of accurate Lp(a) measurement, combined with anticipated future treatments, is expected to play a significant role in improving cardiovascular disease management in the years ahead.