MarketWatch

Roche receives FDA 510(k) clearance for the first blood test in the U.S. measuring Lp(a) in molar units

-- Approximately one in five people worldwide has elevated Lp(a) levels, putting them at increased risk of cardiovascular diseases including myocardial infarction and stroke.1 -- The Roche Diagnostics ...
Nasdaq

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 ...
Ibj.com

Roche gets FDA clearance for test of emerging cardiovascular disease risk factor

Roche, the parent company of Indianapolis-based Roche Diagnostics, said it received FDA clearance to sell a new test to help determine a patient’s risk of an often untested but common, usually genetic ...
MedPage Today

CVD Risk With Twins; Hep C+ Hearts; Stethoscope Screening for Pulmonary Hypertension

FDA gave 510(k) clearance to Roche's Tina-quant Lipoprotein(a) Gen.2 Molarity assay, the test maker announced. Clinicians achieved better lipid screening rates for their patients with outreach letters ...
pix11

Roche receives FDA 510(k) clearance for the first blood test in the U.S. measuring Lp(a) in molar units

INDIANAPOLIS, Jan. 29, 2025 /PRNewswire/ -- Roche announced today that the Tina-quant® Lipoprotein (a) Gen.2 Molarity assay has received 510(k) clearance from the United States Food and Drug ...