Roche receives FDA's Breakthrough Device Designation for its Tina-quant lipoprotein Lp(a) RxDx assay, a blood test for hereditary cardiovascular risk.

Roche receives FDA's Breakthrough Device Designation for its Tina-quant lipoprotein Lp(a) RxDx assay, a blood test measuring Lp(a), a key marker for hereditary cardiovascular risk. The test, developed with Amgen, aims to identify patients who may benefit from emerging Lp(a)-lowering therapies. The assay will be made available on Roche's global network of 90,000 serum work area systems.