Roche has announced that the Tina-quant lipoprotein Lp(a) RxDx assay has received breakthrough device designation from the US Food and Drug Administration (FDA) to identify patients who may benefit from Lp(a)-lowering therapy currently in development. The test has been developed in collaboration with Amgen.
Lipoprotein is emerging as an important, yet under-recognised, potential risk factor for cardiovascular disease, the company said in a press release.
“While modern lifestyles are a major driver, as much as 30% of mortality associated with cardiovascular disease occurs in individuals without modifiable risk factors,” said Matt Sause, CEO of Roche Diagnostics. “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.”
“Lp(a) testing rates are markedly low, and existing lab tests may not consistently and accurately measure Lp(a) levels,” said Jay Bradner, executive vice president of Research and Development and chief scientific officer at Amgen. “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.”
Once approved, the new Tina-quant test is expected to be made available to support the selection of patients who may benefit from an innovative Lp(a)-lowering therapy.
