The Erytra Eflexis is a fully automated benchtop analyzer for pretransfusion compatibility testing that facilitates multiple lab configurations and features real random access.
The guidance addresses cases in which there's enough evidence to conclude that the CDx is suitable for use with a specific group or class of oncology therapies.
The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based test for internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene.
The firm received approval for expanded use of its HIV Combo test, which detects HIV-1 and HIV-2 antibodies and the p24 antigen, on its Vitros ECi/ECiQ Immunodiagnostic System.
The test combines the superior performance of laboratory-based PCR tests and the simplicity and convenience of traditional POC rapid immunoassays, the firm said.