Roche Secures FDA Breakthrough Designation for Lp(a) Cardiovascular Risk Test
Roche announced that its Tina-quant® lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).
This designation is intended to identify patients who may benefit from innovative Lp(a)-lowering therapies currently in development.
Elevated Lp(a) levels are increasingly recognized as a significant risk factor for cardiovascular disease, a major global health concern.
Cardiovascular disease is a leading cause of mortality, with up to 30% of related deaths occurring in individuals without traditional risk factors. Lp(a) is considered a crucial marker for cardiovascular risk, but current medical options to address this issue are limited.
Roche, in collaboration with Amgen, aims to establish elevated Lp(a) as an actionable biomarker to enhance cardiovascular care.
Testing rates for Lp(a) are currently low, and existing tests may not consistently measure Lp(a) levels accurately.
By combining Amgen’s expertise in cardiovascular disease with Roche’s diagnostic capabilities, the goal is to standardize testing and provide critical information to improve cardiovascular risk assessment.
Once approved, the Tina-quant® test is expected to support the selection of patients who may benefit from new Lp(a)-lowering therapies.
