PIK3CA Mutation Analysis, Breast Cancer, IVD
GTR Test Accession: Help GTR000569910.5
Last updated in GTR: 2023-12-08
Last annual review date for the lab: 2023-12-08 LinkOut
At a Glance
Breast neoplasm
Genes (1): Help
PIK3CA (3q26.32)
Molecular Genetics - Targeted variant analysis: RT-PCR
Not provided
Not provided
Not provided
Ordering Information
Offered by: Help
Molecular Oncology Laboratory, LabCorp
View lab's test page
Specimen Source: Help
Test Order Code: Help
Contact Policy: Help
Laboratory can only accept contact from health care providers. Patients/families are encouraged to discuss genetic testing options with their health care provider.
Test development: Help
FDA-reviewed (has FDA test name)
Informed consent required: Help
Decline to answer
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 1
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Total methods: 1
Method Category Help
Test method Help
Instrument *
Targeted variant analysis
* Instrument: Not provided
Clinical Information
Test purpose: Help
Recommended fields not provided:
Technical Information
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
Sensitivity ranges from 2.41-14.04%
View citations (1)
  • Citation: therascreen® PIK3CA RGQ PCR Kit Instructions for Use (Handbook) Germany: Qiagen; May 2019
Proficiency testing (PT):
Is proficiency testing performed for this test? Help

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
College of American Pathologists, CAP

CAP Testing Information Help
Multigene Tumor Panel; PIK3CA; MTP
Recommended fields not provided:
Regulatory Approval
FDA Review: Help
Not provided
Additional Information

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