PIK3CA Mutation Analysis, Tumor
Use
Identification of hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer tumors that may be eligible for treatment with targeted kinase inhibitor therapy (eg, alpelisib). More than 70% of breast cancers are HR positive and HER2 negative. Approximately 40% of patients with HR+/HER2- advanced breast cancer have activating mutations in the PIK3CA gene, inducing hyperactivation of the PI3K pathway.
Special Instructions
A pathology report (final or preliminary) containing specific information must accompany the specimen for testing to be performed. The test will include a slide review, always performed at an additional charge.
Limitations
A negative (wildtype) result does not rule out the presence of a mutation below the detection limits of this assay. This test cannot differentiate between somatic and germline alterations. Rare genetic alterations may lead to false-negatives or false-positives. Test results should be interpreted in the context of clinical findings and other laboratory data.
New York Approved
Methodology
PCR-based (qPCR)
Biomarkers
LOINC Codes
- 60034-6
- 50397-9
- 82939-0
- 69047-9
- 48767-8
- 31208-2
- 80398-1
- 18771-6
Result Turnaround Time
8-12 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
tissue 18 mm(2)
Container
formalin-fixed, paraffin-embedded tissue block
Collection Instructions
Submit a formalin-fixed, paraffin-embedded tissue block with acceptable amount of tumor tissue.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Ambient (preferred) |