Jan. 30, 2025—Roche announced that the Tina-quant Lipoprotein (a) Gen.2 Molarity assay has received 510(k) clearance from the FDA. It’s the first 510(k)-cleared test of its kind available in the United States that measures Lp(a) in nanomoles per liter. By using molar units, laboratory professionals and clinicians can mitigate the influence of particle size differences on the measurement of Lp(a). The test measures Lp(a) in serum and plasma and is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease risk, when used in conjunction with clinical evaluation and other lipoprotein tests.
The test will be broadly available on Roche’s Cobas c analyzers in the United States.