Roche: FDA Grants Breakthrough Device Designation For Bood Test Measuring Lp(a)

(RTTNews) - Swiss drug major Roche Holding AG (RHHBY) announced Wedensday that the Tina-quant lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration. It is to identify patients who may benefit from innovative Lp(a)-lowering therapy currently in development.

The blood test measuring Lp(a), a key marker for hereditary cardiovascular risk, has been developed in collaboration with Amgen (AMGN).

The company noted that Lp(a) is emerging as an important, yet under-recognised, potential risk factor for cardiovascular disease. Worldwide, around one in five people have elevated Lp(a) levels, putting them at increased risk of cardiovascular diseases.

Currently, there is no FDA authorised Lp(a) assay measuring Lp(a) in nmol/L available in the US.

The Roche Diagnostics Tina-quant Lp(a) assay measures lipoprotein (a) in a person's bloodstream. 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.

It will be made available on Roche's installed base of over 90,000 serum work area (SWA) systems worldwide. Roche noted that the assay will be part of its wider portfolio of tests for cardiovascular diseases.

Jay Bradner, M.D., executive vice president of Research and Development and chief scientific officer at Amgen, 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."

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