Roche has received the US Food and Drug Administration’s (FDA) breakthrough device designation for its Tina-quant lipoprotein Lp(a) RxDx assay, a diagnostic tool for cardiovascular disease risk.

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.

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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 healthcare professionals in making informed treatment decisions.

Roche Diagnostics CEO Matt Sause said: “While modern lifestyles are a major driver, as much as 30% of mortality associated with cardiovascular disease occurs in individuals without modifiable risk factors.

“Lp(a) is a critical marker for people at risk of cardiovascular disease, but medicine has had limited solutions to adequately address the problem. Through our collaboration with Amgen, Roche is paving the way to make elevated Lp(a) an actionable biomarker.”

Amgen research and development executive vice-president and chief scientific officer Jay Bradner said: “Lp(a) testing rates are markedly low, and existing lab tests may not consistently and accurately measure Lp(a) levels.

“By combining Amgen’s deep legacy and expertise in cardiovascular disease with Roche’s diagnostic expertise, we can accelerate access to more standardised testing and equip more patients and healthcare providers with important information to better understand their risk for cardiovascular disease.”

The Tina-quant assay will also be available on the company’s installed base of more than 90,000 serum work area systems across the globe.