The PIK3CA–AKT1 Mutation Controls consist of formalin-fixed, paraffin-embedded (FFPE) tissue slices containing embedded cellular DNA with a comprehensive panel of 23 clinically relevant PIK3CA mutations along with the AKT1 E17K mutation. These controls are organized into seven mutation panels, enabling flexible and targeted assay verification across multiple testing needs.
These controls have been used with molecular assay such as PIK3CA mutation and AKT1 assay on the Idylla™ platform (BioCartis), supporting laboratories that use automated, cartridge-based molecular systems for PIK3CA mutation analysis in validation and quality assurance workflows.
| Panel 1 | Panel 2 | Panel 3 | Panel 4 | Panel 5 | Panel 6 | Panel 7 |
|---|---|---|---|---|---|---|
| R88Q | C420R | R88L | N345S | C420G | E545D | AKT E17K |
| N345K | E545K | N345I | C420S | Q546R | ||
| E542K | M1043I | E545G | E545A | G1049S | ||
| Q546K | H1047R | Q546L | Q546E | |||
| G1049R | H1047L | H1047Y |
PIK3CA and AKT1 mutations play an important role in precision oncology and are commonly assessed in FFPE tumor samples across multiple cancer types, including but not limited to:
- Breast cancer
- Colorectal cancer
- Endometrial cancer
- Ovarian cancer
- Head and neck squamous cell carcinoma.
- Other solid tumors where PI3K/AKT pathway alterations are clinically relevant.
Key Features and Benefits
- FFPE format closely mimics clinical tumor samples.
- Coverage of hotspot and non-hotspot PIK3CA mutations plus AKT1 E17K
- Mutations grouped into seven panels for efficient testing strategies.
- Ideal for assay development, method verification, and quality control

