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# FDA Clears Roche Lipoprotein (a) Assay
- URL: https://www.fdaweb.com/fda-clears-roche-lipoprotein-a-assay/
- Published: 2025-01-29T12:00:00.000Z
- Updated: 2026-09-14T14:52:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158563

FDA has cleared a Roche 510(k) for its Tina-quant Lipoprotein (a) Gen.2 Molarity assay that measures lipoprotein (a), or Lp(a), in nanomoles per liter. The company says Lp(a) is an “under-recognized, potential risk factor for cardiovascular disease due to its ability to promote the development of plaques within artery walls, clot formation and aortic valve calcification.” Lp(a) measurement is also useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease when aided by clinical evaluations and other lipoprotein tests, it says.