July 2024—Roche announced that the Tina-quant lipoprotein Lp(a) RxDx assay, developed in collaboration with Amgen, has received breakthrough device designation from the FDA. The assay measures lipoprotein (a) in a person’s bloodstream and is for use in identifying patients who may benefit from Lp(a)-lowering therapy now in development. If approved, the assay will be available on select Cobas platforms.
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