Posted by Michael Wonder on 22 May 2024
Roche granted FDA breakthrough device designation for blood test measuring Lp(a) – a key marker for hereditary cardiovascular risk
22 May 2024 - The test has been developed in collaboration with Amgen.
Roche announced today that the Tina-quant lipoprotein Lp(a) RxDx assay has received breakthrough device designation from the US FDA to identify patients who may benefit from innovative Lp(a)-lowering therapy currently in development.
