The test can be used to help doctors in the emergency room diagnose heart attacks faster and more accurately than other troponin tests on the market, Abbott said.
The algorithm uses age, sex, and information about troponin concentrations in patients to determine the likelihood of a heart attack.
A European study, published today in NEJM, used a POC, PCR-based system to perform CYP2C19 genotyping to guide platelet inhibitor therapy.
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.