Diagnostics Regulatory News

The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.

Research has found that antibodies to the marker HMGCR are highly specific to myositis and are associated with, but not limited to, statin exposure.

Siemens Healthineers received FDA clearances for several assays, including separate allowances for tests using hemoglobin A1c, troponin I, and procalcitonin biomarkers.

The firm is also developing a second system designed to run clinical chemistry tests for low- and medium-volume labs.

A manufacturing defect caused the control line on the affected tests to not display, which can cause test results to be misinterpreted as negative for the presence of amniotic fluid.  

The agency's regulatory plan differs in key areas from a draft of the Diagnostic Accuracy and Innovation Act that had shored up lab industry support.