Siemens Healthineers received FDA clearances for several assays, including separate allowances for tests using hemoglobin A1c, troponin I, and procalcitonin biomarkers.
Since introducing new clinical platforms last year, Sciex has launched an automated sample prep system while Thermo Fisher has begun customer beta testing.
Roche Diagnostics CEO said that it seeks to continue generating cash from its current IVD businesses, in part to fund investments in digital diagnostics.
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 Cobas HPV Test is now approved for use as a primary screening test with BD's SurePath and Hologic's ThinPrep PreservCyt Solution.
Revenues for Roche Diagnostics totaled CHF 6.26 billion for H1, driven primarily by demand for immunodiagnostic solutions.
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 Elecsys beta-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF assays are used to measure peptide biomarkers in the CSF of patients with cognitive impairment.
In June, the FDA cleared tests for a broad range of conditions, including Group B strep, systemic rheumatic disease, and chlamydial or gonococcal urogenital disease.