Roche's Tina-quant Lp(a) test receives FDA breakthrough device designation [Yahoo! Finance]
Amgen Inc. (AMGN)
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Source: Yahoo! Finance
This designation is a significant step towards the approval of the test, which measures lipoprotein(a) levels, a potential risk factor for cardiovascular diseases. Developed in partnership with Amgen, the Tina-quant lipoprotein Lp(a) RxDx assay is designed to identify patients who may benefit from therapies aimed at reducing Lp(a) levels. Elevated Lp(a) is considered an emerging risk factor for cardiovascular disease, which remains a major public health concern. The FDA's breakthrough device designation for the Tina-quant Lp(a) RxDx assay specifically targets its use in selecting patients with a history of atherosclerotic disease and elevated Lp(a) for Lp(a) lowering drug treatment. The test involves a routine blood draw and measures the number of Lp(a) molecules per litre of blood. On receiving approval, the test will be made available on selected cobas-branded platforms. Roche's portfolio of cardiovascular disease tests will be expanded with this assay, aiding healthcar
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