Test Code PIK3B Cell-Free DNA PIK3CA Test, Blood
Shipping Instructions
1. Samples should be transported at ambient temperature or refrigerated (4° C)
2. Samples are viable for 7 days in the Streck Black/Tan Top Tube Kit
Specimen Required
Supplies: Streck Black/Tan Top Tube Kit (T715)
Specimen Volume: Two, 10-mL Streck cell-free DNA (cfDNA) blood collection tubes
Additional Information:
1. Only blood collected in Streck cfDNA tubes will be accepted for analysis.
2. Whole blood will be processed to produce platelet-poor plasma before cfDNA isolation.
Method Name
Polymerase Chain Reaction (PCR)
Specimen Type
Whole bloodSpecimen Minimum Volume
One 10 mL Streck cell-free DNA tube
Specimen Stability Information
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Whole blood | Ambient (preferred) | 7 days | Streck Black/Tan top |
Refrigerated | 7 days | Streck Black/Tan top |
Reject Due To
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.Clinical Information
More than 70% of breast cancers are hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative (HR+/HER2-). Approximately 40% of patients with HR+/HER2- advanced breast cancer have activating mutations in the gene PIK3CA, inducing hyperactivation of the alpha isoform (p110 alpha) of phosphatidylinositol 3-kinase, a key upstream component of the PI3K pathway. Mutations in PIK3CA are associated with tumor growth, resistance to endocrine therapy, and a poor overall prognosis.
Patients with HR+/HER2- advanced breast cancer identified to have a PIK3CA mutation may be eligible for treatment with targeted kinase inhibitor therapy (eg, alpelisib).
This test uses circulating tumor DNA extracted from blood to evaluate for the presence of 10 clinically actionable PIK3CA mutations:
E542K (c.1624G>A)
E542K (c.1633G>A)
E545D (c.1635G>T)
E545G (c.1634A>G)
E545A (c.1634A>C)
H1047Y (c.3139C>T)
C420R (c.1285C>T)
Q546E (c.1636C>G)
H1047L (c.3140A>T)
H1047R (c.3140A>G)
Reference Values
An interpretive report will be provided
Day(s) Performed
Monday through Friday
Report Available
5 to 10 daysPerforming Laboratory

CPT Code Information
81309
Forms
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.