Blood test measuring Lp(a) granted breakthrough device designation by FDA
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Key takeaways:
- A lipoprotein(a) assay received breakthrough device designation from the FDA.
- The assay is designed to aid in the selection of patients who may benefit from an Lp(a)-lowering drug.
Roche announced its lipoprotein(a) assay received breakthrough device designation from the FDA to identify patients with history of atherosclerotic CVD who may benefit from Lp(a)-lowering therapy currently in development.
The breakthrough device designation is intended to expedite the development and review of devices intended to treat a serious condition in which preliminary clinical evidence indicates potentially substantial improvement over available devices.
This assay (Tina-quant), developed in collaboration with Amgen, measures Lp(a) molecules per liter in a patient’s blood, which may serve as an actionable biomarker, according to a company press release.
Currently, there is no FDA-approved Lp(a) assay measuring Lp(a) in nmol/L in the U.S. If approved, the assay will be available on selected serum work area platforms (Cobas, Roche), according to the release.
"Lp(a) testing rates are markedly low, and existing lab tests may not consistently and accurately measure Lp(a) levels," Jay Bradner, MD, executive vice president of research and development and chief scientific officer at Amgen, said in the release. "By combining Amgen’s deep legacy and expertise in cardiovascular disease with Roche’s diagnostic expertise, we can accelerate access to more standardized testing and equip more patients and health care providers with important information to better understand their risk for cardiovascular disease."
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