A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
PIK3CA Mutation Analysis
Test CodeCPT Codes
81309
Preferred Specimen
Minimum Volume
Other Acceptable Specimens
Instructions
Paraffin block is the preferred sample type. Sample source and block ID are required on the requisition form and a pathology report must be submitted.
Whole Blood (acceptable): Follow standard whole blood collection procedures. Collect 3-5 mL whole blood in an EDTA tube. Record sample type, collection time, and date on both tube and requisition form.
For bone marrow (acceptable) collection, the notation of sample type, collection time, and date on the tube and requisition form is required. Ship sample at refrigerated temperature or room temperature. Ship immediately to maintain stability.
Transport Temperature
Whole blood and bone marrow: Refrigerated (cold packs)
Specimen Stability
FFPE tissue/slides
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Whole blood, bone marrow
Room temperature: 72 hours
Refrigerated: 72 hours
Frozen: Unacceptable
Methodology
Next Generation Sequencing
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Report available: 7 Days
Reference Range
Clinical Significance
Phosphoinositide 3-kinase (PI3K) is a lipid kinase responsible for the generation of an important signaling second messenger involved in cell survival and proliferation. The most highly expressed catalytic subunit, p110alpha, is encoded by the PIK3CA gene (Ch3q26.32). PIK3CA has been shown to be mutated in a high percentage of human cancer (10-15% overall), including endometrial (36%), breast (27%), and colorectal cancers (23%).
Mutational hotspots in PIK3CA include exons 1, 9 and 20. Mutations in these regions have been reported to be associated with poor outcome in each of these malignancies and may provide patient stratification in breast cancers. In addition, mutations in PIK3CA correlate with resistance to cetuximab therapy in colorectal cancer patients. PIK3CA mutation status may therefore provide prognostic information for a number of solid tumors, as well as aid in the improvement of molecular stratification of patients.
PIK3CA mutation status, especially in combination with other molecular tests, will also be an important consideration in the design of therapeutic strategies for certain malignancies. This test covers greater than 95% of the reported mutations in PIK3CA.
Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153