The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.
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.
With the new clearance, DiaSorin's test can be run on genital swabs, and all cutaneous and mucocutaneous swab samples, as well as CSF samples.
Beckman said that its assay completes the reproductive menu for its Access immunoassay systems and provides better operational efficiency for labs.
A combined assay to screen blood donations for HIV and hepatitis viruses and a test for West Nile virus are now cleared to run on the Procleix Panther system.
In a new guidance, the US regulatory agency encouraged voluntary inclusion of LOINC codes with IVDs as a means to promote data interoperability.