Device Dossier

Acquired genetic alteration IVDs

Device Dossier for Acquired genetic alteration IVDs (CT929 - Acquired genetic alteration IVDs, Class 3, sponsor Leica Biosystems Melbourne). ARTG record,…

Intended purpose

For the qualitative detection of; a) Her2 (Human Epidermal Growth Factor Receptor 2) oncoprotein status via immunohistochemistry or b) amplification of HER2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. As an aid in the assessment of patients for whom Herceptin®* (trastuzumab) treatment is being considered

TGA Public Summary