Device Category Dossier

CT929 - Acquired genetic alteration IVDs

Device Category Dossier for CT929 - Acquired genetic alteration IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

In vitro diagnostic tests detect genetic alterations including gene mutations, sequence variations, and gene rearrangements using techniques such as high throughput parallel sequencing and multiplex polymerase chain reaction analysis on DNA or RNA extracted from tissue, blood, or bone marrow specimens. These tests serve as companion diagnostics to guide treatment selection and monitor disease burden in patients with cancers including non-small cell lung cancer, acute myelogenous leukaemia, and B-cell malignancies.