IDYLLA™ PIK3CA-AKT1 MUTATION ASSAY (RUO*)
The Idylla™ PIK3CA-AKT1 Mutation Assay, performed on the Biocartis Idylla™ System, is a fully automated real-time polymerase chain reaction (PCR) Assay for the qualitative detection of 13 mutations in the PIK3CA gene and one mutation in the AKT1 gene in formalin-fixed, paraffin-embedded (FFPE) human tissue sections. The Idylla™ PIK3CA- AKT1 Mutation Assay covers the entire process from FFPE sample to result, including fully integrated sample preparation, liberation of nucleic acids, real-time PCR amplification and detection, and data analysis.
*For research use only. Not for use in diagnostic procedures.
SPECIMEN REQUIREMENTS
- 1x 5 μm FFPE tissue section if tissue area 50-600 mm²
- 1x 10 μm FFPE tissue section if tissue area 25-300 mm²
- Neoplastic cells ≥20% - if less, macro-dissection is required
