PIK3CA Mutation Analysis

PIK3CA Mutation Analysis

Test Code

16897
81309
16897
81309
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection is not available in your area through Quest Mobile.

Clinical Significance

PIK3CA Mutation Analysis -

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 ...

Test Resources

Test FAQ

PIK3CA Mutation Analysis

Test Details

Methodology

Next Generation Sequencing

Assay Category

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.

Reference Range(s)

Not detected

Alternative Name(s)

PI3K,Phosphatidylinositol 3-Kinase,Phosphoinositide 3-Kinase,p110alpha

LOINC® Codes, Performing Laboratory

Service Area must be determined

Methodology

Next Generation Sequencing
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.

Reference Range(s)

Not detected

Alternative Name(s)

PI3K,Phosphatidylinositol 3-Kinase,Phosphoinositide 3-Kinase,p110alpha
Service Area must be determined

Preferred Specimen(s)

Formalin-fixed, paraffin-embedded tissue

Alternative Specimen(s)

5 mL whole blood collected in an EDTA (lavender-top) tube or sodium heparin (green-top) tube • 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube or sodium heparin (green-top) tube • 8 unstained charged (+) slides 

Minimum Volume

3 mL whole blood • 1 mL bone marrow aspirate • 4 unstained charged (+) slides 

Collection 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 collections procedures. Collect 3-5 mL whole blood in an EDTA tube. Record sample type, collection time, and date on both tube and requisition form.

Bone marrow (acceptable) collection: The notation of sample type, collection time, and date on the tube and requisition form is required. Ship sample refrigerated or room temperature. Ship immediately to maintain stability.

Do not reject specimens. Send to laboratory for screening.

Transport Container

Formalin-fixed, paraffin-embedded tissue block 

Transport Temperature

Room temperature

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

Setup Schedule

Service Area must be determined
Formalin-fixed, paraffin-embedded tissue
5 mL whole blood collected in an EDTA (lavender-top) tube or sodium heparin (green-top) tube • 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube or sodium heparin (green-top) tube • 8 unstained charged (+) slides 
3 mL whole blood • 1 mL bone marrow aspirate • 4 unstained charged (+) slides 
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 collections procedures. Collect 3-5 mL whole blood in an EDTA tube. Record sample type, collection time, and date on both tube and requisition form.

Bone marrow (acceptable) collection: The notation of sample type, collection time, and date on the tube and requisition form is required. Ship sample refrigerated or room temperature. Ship immediately to maintain stability.

Do not reject specimens. Send to laboratory for screening.
Formalin-fixed, paraffin-embedded tissue block 
Room temperature

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

Service Area must be determined
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection is not available in your area through Quest Mobile.
Test Details

Clinical Significance

Test Resources

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

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