The test can be used to rapidly and accurately identify patients suffering from heart attacks, and to help identify low-risk patients who may be safely discharged, the firm said.
The company is developing point-of-care tests for monitoring kidney function (penKid) and endothelial dysfunction in patients at risk of heart failure.
The test uses the same blood draw of a routine health exam and was designed to be unaffected biotin, a vitamin supplement that may skew some lab test results.
The agency cleared two of the firm's high-sensitivity troponin I assays for use on the Atellica IM and Advia Centaur XP/XPT immunoassay analyzers.
The investigators noted that the Siemens assay enables more institutions to introduce high-sensitivity cardiac troponin testing for patients outside the US.
They found that cMyC protein was more abundant than cardiac troponin in heart disease patients and that it could be used to quickly rule out heart attack.
Sphingotec's proenkephalin and adrenomedullin biomarkers and Nexus Dx's Nexus IB 10 point-of-care testing platform will be merged under jointly owned holding company Polaris MediNet.
Practice recommendations could serve as a guide for labs considering using the high-sensitivity assays as they become available, authors said.
The company will pay the US $33.2 million to settle allegations that it caused hospitals to submit false claims to federal healthcare programs.
Randox believes its cash commitment will fill its clinical diagnostics pipeline for years to come, and collaborators include specialists in high-resolution imaging and nanotechnology.