Roche announces that its Tina-quant lipoprotein Lp(a) RxDx test has been designated a breakthrough device by the U.S. FDA to identify patients likely to benefit from an innovative Lp(a)-lowering therapy currently in development.

Developed in collaboration with Amgen, this Roche Diagnostics test measures Lp(a) in a person's bloodstream and will be available on the installed base of more than 90.000 serum working area (SWA) systems worldwide.

'Approximately one in five people worldwide has high levels of Lp(a), putting them at increased risk of cardiovascular disease, including myocardial infarction and stroke', stresses the Swiss healthcare group.

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