Roche Diagnostics, a unit of Swiss drug major Roche, has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Tina-quant lipoprotein Lp(a) RxDx assay.

Developed in collaboration with Amgen, the Tina-quant Lp(a) test is designed to identify patients who could benefit from Lp(a)-lowering drugs that are presently in the development phase.

The test measures Lp(a), a key marker for hereditary cardiovascular risk, in a person’s bloodstream.

It is intended to be used for identifying patients with high levels of Lp(a) and a history of atherosclerotic disease.

Amgen chief scientific officer and research and development executive vice president Jay Bradner said: “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.”

An Lp(a) test involves a normal blood draw, wherein a small blood sample is used for assessment.

Roche’s test quantifies the concentration of Lp(a) molecules per litre in the bloodstream, supporting Lp(a) as a valuable biomarker for the future.

The Swiss firm said the Tina-quant Lp(a) test will be accessible on specific cobas platforms upon approval.

Presently, there is no FDA-authorised Lp(a) assay in the US for measuring the biomarker in nmol/L, said Roche.

The test will join the company’s portfolio of tests for cardiovascular diseases. Collectively, these tests are said to empower healthcare providers to make informed decisions, granting patients access to new and advanced treatments.

The Tina-quant assay will also be accessible on the drug maker’s installed base of more than 90,000 serum work area systems all over the world.

Roche Diagnostics CEO Matt Sause said: “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.”