The FDA does not allow labs to report hs-troponin results below assays' limits of quantitation, which some argue leaves actionable information on the table.
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.
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.
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.
