FDA updates its list of authorized companion diagnostic devices to 226 entries, covering NGS assays, liquid biopsies, group labeling, and key biomarkers.

Australia's TGA has published a new version of its regulatory guidance for IVD companion diagnostics (CDx), with a direct impact on medical device manufacturers and sponsors of drugs and biologics. The document describes the legal framework, clinical and analytical assessment criteria, classification, ARTG submission requirements and the use of in-house developed CDx.