PIK3CA

Biomarker

PIK3CA mutations activate the PI3K signaling pathway. These alterations are actionable in breast and other cancers.

Approvals
6
Indications
1
Therapies
3
Mapped tests
4

Where this biomarker is used

Each approval combines this biomarker with a specific indication and therapy. Select a therapy in the tables below to open its FDA-defined testing pathway.

Indication-specific approvals

Approvals where PIK3CA is defined directly in the indication labeling.

IndicationBiomarker criteriaTherapies
Breast Cancer
Solid Tumor · Breast
  • C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y
  • alterations (including mutations)
  • AKT1/PTEN alterations
Tumor-agnostic approvals

Approvals defined at the solid tumor level where PIK3CA is part of the eligibility criteria.

No tumor-agnostic approvals are currently mapped for this biomarker.

Tests that measure this biomarker

These assays report PIK3CA as part of their validated menu. In many cases they are identified in FDA labeling as acceptable companion diagnostics for specific approvals.

Test
FoundationOne CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Tissue (FFPE)

Reports PIK3CA as part of its biomarker panel.

Test
FoundationOne Liquid CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Whole blood

Reports PIK3CA as part of its biomarker panel.

Test
MI Cancer Seek (MCS)
Caris Life Sciences
Method
NGS
Specimen
Tissue (FFPE)

Reports PIK3CA as part of its biomarker panel.

Test
therascreen PIK3CA RGQ PCR Kit
QIAGEN GmbH
Method
PCR
Specimen
Tissue (FFPE)

Reports PIK3CA as part of its biomarker panel.

This view is scoped to PIK3CA. You can also see how it compares with other biomarkers and indications on the Know Your Companions™ map.