Device Dossier
Acquired genetic alteration IVDs
Device Dossier for Acquired genetic alteration IVDs (CT929 - Acquired genetic alteration IVDs, Class 3, sponsor Qiagen). ARTG record, intended purpose,…
- GMDN category: CT929 - Acquired genetic alteration IVDs
Intended purpose
The therascreen PIK3CA RGQ PCR kit is intended for use as a companion diagnostic test, to aid clinicians in identification of breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA mutation detected result.