Several companies will receive grants to develop hepatitis C molecular point-of-care and core antigen diagnostic assays.
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.
This drug is the first FDA-approved IDH1 inhibitor and will be used to treat adult patients with relapsed or refractory acute myeloid leukemia.
Akers Biosciences reported this week that its first quarter revenues dropped 55 percent year over year, as lower yields in the process of extracting antigens for its flagship test product led to lower production levels and backorders.
The firm booked $484 million in revenues for Alere rapid diagnostics in the quarter, led by sales for infectious disease and cardiometabolic testing.
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.
Researchers have established that two simple tests can determine whether a person meets guidelines to receive antiviral treatment.
The investigators noted that the Siemens assay enables more institutions to introduce high-sensitivity cardiac troponin testing for patients outside the US.
The trial, part of a multiyear effort to standardize HbA1c testing in labs, will be repeated annually with more labs participating and more countries represented.
The expanded clearance includes use of the test to assess a patient's risk of developing diabetes. The assay was cleared to run on the Afinion AS100 Analyzer.