Within the "Big Three" conditions, misdiagnoses related to stroke, sepsis, and lung cancer accounted for the most high-severity diagnostic error cases.
A Roche executive said he expects essentially all the firm's US troponin customers will convert to the high-sensitivity assay over the next two to three years.
GenMark Diagnostics received clearance for a third BCID panel that the firm said paves the way for a customizable approach to sepsis MDx.
Beckman Coulter got regulatory clearance for three in vitro diagnostic products, including its DxH 520 hematology analyzer for low-volume clinical labs.
In a hospital setting, 1 in 20 patients had cardiac troponin levels above the cut off for diagnosing a heart attack, including patients with no clinical signs of one.
The high-sensitivity test runs on the Quidel Triage Meter Pro instrument and joins a growing list of similar tests that have recently received regulatory approvals.
In the study, the POC assay produced a result in 15 minutes with comparable performance to a high-sensitivity laboratory assay in ruling out AMI.
A high-sensitivity cardiac troponin T assay ruled out myocardial infarction in about 55 percent of patients within an hour, according to a new study.
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.