FDA Grants Roche Tina-qant Lp Assay Breakthrough Device Designation – a key marker for hereditary cardiovascular risk

Roche announced  that the Tina-quant® lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. FDA  to identify patients who may benefit from innovative Lp(a)-lowering therapy currently in development. Lp(a) is emerging as an important, yet under-recognised, potential risk factor for cardiovascular disease, a major public health issue.

“While modern lifestyles are a major driver, as much as 30% of mortality associated with cardiovascular disease occurs in individuals without modifiable risk factors,2” 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,3” said Jay Bradner, M.D., 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.