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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.
The FDA cleared Roche's Elecsys BRAHMS PCT electrochemiluminescence immunoassay for an expanded use to aid in antibiotic therapy decision-making.
The investigators noted that the Siemens assay enables more institutions to introduce high-sensitivity cardiac troponin testing for patients outside the US.
The FDA said that pooled testing of donations using a screening test that it has licensed is a sufficient method for complying with its testing regulations.